SABIN VACCINE REPORTthe newsletter of the Albert B. Sabin Vaccine Institute

Volume III, Number 1, May 2000

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In This Issue

The Hookworm VaccineInitiative Unfolds

International disease burdennecessitates vaccine

development.

6,7

The Search for an AIDSVaccine

Gary Nabel gives AIDSVaccine Research a Face.

4,5

China Confronts her AIDSEpidemic.

5

UNICEF and RotaryIntensify Polio

Eradication Efforts.

Public and private sectorspartner to free the world of

polio by 2003.

8

SmithKline Beechamintroduces a new

combination vaccine.

Pentavalent vaccine joins theranks of common combinationvaccines like DPT and MMR.

3

Cancer VaccineResearchers Making

Advances.

11

Experts Recommend NewFlu Vaccine

3

BOOK REVIEW: The Politics ofInternational Health

10

SVI Chairman advocatesvaccine use.

12

JOHN M. CLYMER

The Albert B. Sabin Vaccine Institute hasreceived an $18 million grant from the Bill& Melinda Gates Foundation. The funds will

be used for the development of a vaccine to preventhookworm infection. Approximately one-quarter ofthe world’s population is infected with hookworm.

“This grant from the Bill & Melinda GatesFoundation represents enlightened philanthropybecause it will help us over the major economicbarriers that have prevented development of ahookworm vaccine,” said H. R. “Shep” Shepherd,chairman of theSabin VaccineInstitute.

“This is a hugestep towarddemocratizingh e a l t h c a r ethroughout theworld,” saidS h e p h e r d .“Hookworms infectabout one billionpeople, mostly indeveloping countries.They stunt children’sgrowth, sapvictims’ energyand make themanemic. Avaccine is the only realistic way to protect all peoplefrom this parasite.”

Peter J. Hotez, called “one of the world’s fewhookworm experts,” in a 1998 Washington Postarticle, will be the principal scientist directing theproject. He is a member of the Institute’s council ofscientific advisors.

“Hookworm is a particularly serious problemin rural China. In some villages, more than one halfof the population is infected,” Hotez said. He

frequently visits remote areasof China to conduct researchas a visiting professor at theChinese Academy ofPreventive Medicine’sInstitute of Parasitic Diseaseand the Peking Union MedicalCollege. The parasite isestimated to be similarlyprevalent in India, and is amajor health problem in

certain Latin American countries, as well.“Hookworms infect people of all ages but they

are particularly devastating in children,” explainedHotez. “Chronic hookworm-associated intestinalblood loss leads to iron deficiency and proteinmalnutrition. These conditions often retardintellectual and physical growth,” according toHotez. People who are treated for hookworm tendto become reinfected, he added.

No single sector – academia, government,industry or philanthripy – can develop a vaccinealone, Shepherd noted. The Sabin Vaccine Institute

will draw on expertise and resources from eachsector to translate scientific knowledge abouthookworm antigens into areal product that helpspeople lead healthier lives, hesaid.

“We are proud tosupport the Albert B. SabinVaccine Institute and itsquest to find a hookwormvaccine, which will freemillions of the world’s mosteconomically disadvantaged

p e o p l efrom thisdisease,”s a i dGordon W. Perkin, M.D.,director of the Global HealthProgram at the Bill & MelindaGates Foundation.

The Sabin VaccineInstitute’s mission is to save livesby stimulating development ofnew vaccines and by increasingimmunization rates. It wasfounded in 1993 and named forAlbert B. Sabin, developer of theoral polio vaccine that has beenat the heart of the nearly-complete worldwide effort toeradicate paralytic polio. This is

the Institute’s first research and developmentprogram. Other Institute programs bring scientiststogether to share cutting-edge ideas and data toaccelerate vaccine development, and advocatesound immunization strategies to combat disease.

The Bill & Melinda Gates Foundation isdedicated to improving people’s lives by sharingadvances in health and learning with the globalcommunity. Ledby Bi l l Gates’father, William H.Gates, Sr., andPatty Stonesifer,the Seattle-basedFoundation hasan asset base ofapproximately$21.8 billion. Preventing disease among poorchildren by expanding access to vaccines, anddeveloping vaccines against malaria, HIV/AIDS andtuberculosis, are central priorities. Other majorefforts include extending unprecedentedopportunities for learning by bringing computers withInternet access to every eligible public library in theU.S. and Canada, and providing scholarships toacademically talented minority students with severefinancial need through the Gates Millennium ScholarsProgram. v

John Clymer is director of external affairs for the AlbertB. Sabin Vaccine Institute.

“Hookworm is aparticularly seriousproblem in ruralChina. In somevillages, more thanone half of thepopulation isinfected,” Hotezsaid.

“This grant from theBill & Melinda GatesFoundationrepresentsenlightenedphilanthropy becauseit will help us overthe major economicbarriers that havepreventeddevelopment of ahookwormvaccine...”

“Chronic hookworm-associatedintestinal blood loss leads toiron deficiency and proteinmalnutrition. These conditionsoften retard intellectual andphysical growth...”

For complete information and grant guidelines visitwww.gatesfoundation.org.

Gates Foundation Awards $18 Million to Sabin InstituteFunds Awarded for Development of Hookworm Vaccine

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Dr. Peter Hotez visits children at a health clinic in Beijing.

2 SABIN VACCINE REPORT February 2000

Too often, these deaths occur becauseother countries’ restrictive or bureaucraticpolicies make vaccines unavailable to theircitizens. The United States works hard to helpremedy this problem, but if our own citizensbegin to doubt vaccines, we could initiate adangerous chain reaction around the world.And if the number of unvaccinated childrenbegins to grow, the worldwide benefits ofimmunization will rapidly erode - causingpreventable illnesses to proliferate globally.

This has already happened in the past.In the 1970s, rumors associated with apertussis vaccine lead to a drop in vaccinationrates in several countries and a consequent

r ise in theprevalence ofthe disease.We must notmake the samemistake again.

As weenter the 21stc e n t u r y ,vaccines are

poised to play an increasingly central role inour future, saving millions of lives each yearwhile dramatically cutting health care costs.On the near horizon, a new vaccine awaitingFDA approval promises to protect children frompneumonia and meningitis. And in the years tocome, vaccines could conquer some of ourcentury’s worst scourges - malaria, dysentery,AIDS and even some cancers. However, amisinformed public outcry could delay thisexciting progress and cost countless lives.

Despite early fears, vaccines never didendow people with the qualities of cows. Letus not be cowed today by the latest crop ofvaccine myths. We must spread the facts - notignorance - so that humankind will continue toenjoy the benefits of our greatest medical miracle.

H. R. Shepherd is Chairman of the Albert B. SabinVaccine Institute.

Doubting Vaccines Is Dangerous BusinessIn the 1790s,people receivingthe world’s firstvaccine - thesmallpox vaccine -were convincedthey would take onthe physicalcharacteristics ofthe cows that wereused to create themedicine. Todaywe know theirfears were

unfounded; in fact, smallpox has now beeneradicated. Yet after two centuries of successagainst a host of crippling and fatal diseases,vaccines are under attack from unwarrantedfears once again.

Recent television, print and radio newsstories in the United States, along with agrowing number of Internet sites, are claiming

vaccines aredangerous or evenfatal. In response torumors that vaccinesare the catalysts ofsuch wide-ranging

disorders as autism, asthma and diabetes,some parents have begun questioning thewisdom of vaccinating their children. Thesefears are both strange and perilous. They arebased not on reality or scientific evidence buton ignorance and, in many cases, the need tof ind a medical scapegoat when theunexplainable occurs. Those who allowthemselves to be ruled by these baselessmisconceptions risk undermining one ofhumankind’s greatest medical resources. AsGoethe warned, “Nothing is more dangerousthan ignorance in action.”

In this case, ignorance could bringirreparable harm to us all.

Before the development of a measlesvaccine in the 1960s, there were some500,000 cases each year, and thousands died

from the disease. By 1998 there were only1,000 diagnosed cases and none of thosecases were fatal. In 1968, there were morethan 150,000 cases of mumps in the U.S. butby 1993, there werejust over 11, 500.

Vaccines havereduced infectionand death from the fluby 54%. And thanksto vaccines, therehas not been a single case of polio in theUnited States since 1975. Cholera, typhoid,German measles, whooping cough anddiphtheria are only a sampling of the diseasesthat vaccines currently control in the U.S.

In all, vaccines have protected countlessmillions of lives - including yours and mine -from once-common killers. The fact isvaccines are one of the safest and mosteffective medical interventions of our time.Moreover, they are one of the mosteconomical; today, every dollar spent onvaccines saves $27 in treatment.

Unfortunately, the very success ofvaccines has caused a dangerous outbreak ofcomplacency and misunderstanding. Many oftoday’s young parents have neverencountered the diseases their children’sinoculations prevent and consequently believethese horrors couldn’t possibly return.Meanwhile, preventable killers such asmeasles, pertussis (whooping cough) andhepatitis B lurk patiently in the shadows -poised to make a widespread comebackshould immunizations decline.

If we are to keep infectious diseases atbay, we must eliminate the notion that they nolonger pose a serious threat. Every year in theUnited States, approximately 70,000 people- including 500 children - die unnecessarilyfrom diseases that could have been preventedby existing vaccines. That’s one person everyeight minutes. Throughout the world, millionsof people die annually from vaccine-preventable diseases.

H. R. Shepherd,Chairman of the SabinVaccine Institute

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“Nothing is moredangerous thanignorance in action.”

Today, every dollarspent on vaccinessaves $27 intreatment.

Every year in the UnitedStates, approximately 70,000people - including 500children - die unnecessarilyfrom diseases that couldhave been prevented byexisting vaccines.

The Sabin Vaccine Report is published by theAlbert B. Sabin Vaccine Institute.

Subscriptions are free.

The Albert B. Sabin Vaccine Institute is anon-profit institute dedicated to continuingthe work and achieving the vision of Albert

B. Sabin: to fully realize the potential ofvaccination to prevent disease.

Founded in 1994, the Institute strives toprevent disease by promoting the

development of new vaccines and deliverysystems.

Dedicated to Disease Preventionwww.sabin.org

WRITERS/STAFF

John ClymerNishiena GhandiGboku Lumbila

Jessica Quinn

CONTRIBUTORS

Peter J. Hotez, MD PhDH. R. ShepherdJohn Shao, PhD

Myrna Watanabe, PhDPatricia Thomas

EDITOR

Charlene A. Flash

ASSISTANT EDITOR

Veronica Korn

COPY EDITOR

Daphna Gregg

H. R. Shepherd, Chairman

Fran Sonkin, Executive Vice President

Philip K. Russell, Special Advisor to the Chairman

Peter J. Hotez, Chair Scientific Advisory Board

Lea Gill, Aide to Chairman

John M. Clymer, Director External Relations

Valerie Manda, Visiting Postdoctoral Fellow

Charlene A. Flash, Research Fellow

Veronica Korn, Research Associate

Gboku Lumbila, Executive Assistant

Please direct inquiries to:

SABIN VACCINE REPORT

58 Pine StreetNew Canaan, CT 06840

phone: 203.972.7907facsimile: 203.966.4763email: info@sabin.org

SABIN VACCINE INSTITUTE STAFF

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SABIN VACCINE REPORT February 2000 3SABIN VACCINE REPORT February 2000

Combination Vaccines Minimize Pain; Save Money

Experts Recommend New Flu Vaccine For Next SeasonBY JESSICA QUINN

The rising temperatures and bloomingflowers not only signal the beginning ofspring, but also the end of the flu

season. Very early this season betweenDecember 25, 1999 and January 15, 2000,many people contracted the flu. This earlypeak in the season sent many scrambling toget flu shots for fear this was to be the worstflu season yet. Statistics compiled by theCenters for Disease Control show, however,that this year was not much different thanprevious years. The flu vaccine effectivelypreempted what would have been the worstflu season yet. “Epidemic” flu rates andhospital visits linked to the flu were fairlycomparable to the last five seasons.

According to the CDC, deaths frompneumonia or those directly linked to influenzawere only up 2 percent to 11.2 % during thelast few seasons. The flu season lasts fromOctober until February.

According to the Mortality ReportingSystem (MRS), the highest percentage ofpatient visits for influenza-like-illness (ILI) andpatient deaths occurred in January. One

hundred and twenty-two cities contribute to theMRS data, reporting the number of deathsattributed to influenza or pneumonia. BothMRS and the State and TerritorialEpidemiologists Report are part of the Centersfor Disease Control’s (CDC) influenzasurveillance system. By this system the CDCaims to determine the strains of flu virusescirculating and monitors their effects on theUnited States population.

Last year’s flu season was marked bypeople who contracted the flu although theyhad already been vaccinated. Health expertscannot determine whether the strain has grownless effective or whether they received moresamples of this population than usual.According to the FDA, each Fall between 60and 80 million Americans receive the influenzavaccine. Health experts choose the formulathey believe will protect the most people fromthe most common type of the flu virus at leastone month prior to the distribution of shots.

Although the flu season is behind us, healthofficials continue to study the virus and itseffects. Work has already begun on developingnext season’s vaccine for our next flu season

that will counter the strains circulated thiswinter. The influenza viruses infecting humansand animals are isolated and studied. WHOCollaborating Centers then sequence andidentify the categories of the viruses. EachFebruary the results are discussed in Genevaand a recommendation for the composition ofthe next season’s vaccine is made by theWHO. The composition of the vaccine for theNorthern Hemisphere’s flu season (November2000- April 2001) has been determined andgiven to vaccine manufacturers by the WorldHeath Organization (WHO).

In the Unites States a panel of experts,or Federal Health Advisors, reviewed theWHO findings and recommended a change tothe formula for next season’s flu vaccine. InMarch these experts advised the Federal DrugAdministration in the United States to replaceType A strain vaccine with a new strain notedin Panama. The type A strain, common last fluseason, was first identified on the South Pacificisland of New Caledonia. v

Jessica Quinn is a Sophomore Biology major andEnglish minor at Georgetown University.

BY VERONICA KORN

Infant immunization schedules requiring severalinoculations during each doctor’s visit maybecome a thing of the past as more

combination vaccines are developed andapproved. A combined vaccine will have far-reaching affects for global immunizationcampaigns particularly in developing nations. Theavailability of a combined vaccine—a vaccineproduced from cultures of a number oforganisms—simplifies the actual implementationof inoculations, by enabling a single injection forapplication of multiple vaccines. Combinationvaccines minimize pain and discomfort, cost andtime; and would maximize successful immunizationprograms by increasing compliance.

The DTP (diphtheria pertussis poliovaccine) was among the first of suchcombination vaccines, being developed in1943, and licensed for use in the US in 1948.This and others are commonly used in doctors’offices and hospitals, namely the MMRvaccine against measles, mumps and rubella(manufactured by Merck), and the DTaPvaccine against diphtheria, tetanus andpertussis (multiple manufacturers). Currently,North American Vaccines and WyethVaccines and Nutrition are concentrating onfurther increasing the coverage in combinationvaccinations to protect against up to five,rather than the standard three, childhooddiseases at once.

In July 1999, SmithKline Beecham (SB)submitted a license application to the UnitedStates Food and Drug Administration (FDA) fora new combination vaccine against diphtheria,tetanus, pertussis, hepatitis B and polio. Whilethe much used DTaP combined vaccine hasexisted for some time, the SmithKline product,called InfantrixDTaPaÒHepB-IPV, would nowprotect against five major childhood diseases andreduce the number of shots required for effectiveimmunization from nine to three. U.S. SmithKline

spokesperson Carmel Hogan during a telephonicinterview recently, said that should the FDAapprove this vaccine, it would be the firstpentavalent vaccine licensed in the country. Thecompany already has had success with othercombination vaccines such as Twinrix, forHepatitis A and Hepatitis B, as well as Infantrix,the DTaP inoculation, which the FDA approvedin 1997. Hogan said the success of thesevaccines has largely led to a greater concentrationwithin SB on combination vaccine development.

Valerie Manda, a medical microbiologistfrom the Medical University of South Africa(MEDUNSA) in Pretoria, South AfricaCombination vaccines will increase comliancebecause they will minimize multiple shots.“Combination vaccines will increase comliancebecause they will minimize multiple shots. It’sgood for technology to go ahead...progress, butbasic problems still need to be conquered.”Amongst these problems, Manda citedaccesibility to vaccines and vaccination clinics.In poorer countries, she noted, simple situations

such as staffing issues in clinics and basic povertyoften prevent the population from receiving vaccines.

Preliminary randomized studies on over7,000 children in the U.S. for a total of 20,000worldwide show the combination vaccine to beas safe, efficacious and immunogenic as themonovalent vaccines. Although combinationvaccines such as the SKB pentavalent requirejust one inoculation per visit, the pentavalentvaccine would still be repeated on the childhoodimmunization schedule at two, four and six monthsof age, said Hogan.

When asked about individual vaccines andthe future of companies who manufacture them,Hogan said those vaccines will still be needed asbooster, or supplemental, shots for both childrenand adults. SB has other combination vaccinesin Phase three of development (see fig.1). Theseinclude an MMR-Varicella, measles, mumps,rubella and chicken pox in phase IIIa and hepatitisA + Salmonella typhi in phase IIIb. v

Veronica Korn is a Research Associate at the SabinVaccine Institute.

Brand Combination Company Stage

OTHER COMBINATION VACCINES

Twinrix Hepatitis A+B SmithKline Beecham Marketed

Tetracel Diptheria,Tetanus, Wyeth-Lederle Phase IIPertussis,Hib Disease (American Home Products)

Certiva Diptheria and Tetanis Toxoids, North American Vaccines MarketedAcellular Pertussis Vaccine Absorbed

Unnamed MMR+Varicella SmithKline Beecham Phase III

SOURCE: SmithKline Beecham PLC, American Hompe Products, North American Vaccines

4 SABIN VACCINE REPORT February 2000

BY PATRICIA THOMAS

On a muggy Sunday morning inBaltimore, speaking at thegraduation ceremony of Morgan State

University, President Clinton challenged science todevelop an AIDS vaccine within 10 years. To speedthis globally important effort, he announced that a

major new AIDSVaccine ResearchCenter (VRC) would becreated at the NationalInstitutes of Health. “Ifthe 21st century is to bethe century of biology, letus make an AIDSvaccine its first greattriumph,” the Presidentsaid to great applause.

Few would haveguessed that nearly twoyears would pass beforeHealth and Human

Services Secretary Donna Shalala officiallyannounced that physician-scientist Gary Nabel,known primarily as a gene therapy researcher atthe University of Michigan, would come on boardto lead the VRC.

The long interval between the President’sMay 1997 announcement and Nabel’s hirein March of this year provided plenty of timefor loose talk. Many vaccine researchers saidthat the 10-year goal was overly optimistic;others predicted that the VRC would benothing more than a cosmetic reshuffling ofcurrent NIH researchers and resources. Therewas no director in sight in August 1998, whenthe NIH broke ground for the VRC, a five-story building expected to cost $26-million.Top drug company executives and experiencedvaccinologists were said to have turned downthe job because the pay was too low, therewere too many bosses and too little authority,or the whole idea was nothing more than anempty political gesture.

Gary Nabel walked into this gossipytown square with no visible signs ofdefensiveness or distress. Whether he’spresiding over planning sessions, speaking atlarge scientific meetings, or meeting with AIDSadvocates, he speaks his mind calmly andcomes across as a solid, reasonable fellow.He’s a tall lean man of 46, losing hair earlierthan he would like, with expressive hands thathe uses to underline his points. He listensclosely to others and is quick to murmur assentwhen he hears something he likes.

Dark horse from MichiganNIH Director Harold Varmus first

approached Nabel about the VRC directorship in

early 1998. Although he had shepherdedexperimental gene therapies from the lab to theclinic, and this work was central to him, he knewthat these advances could help only a limited numberof people. And here was Varmus talking about thesearch for an AIDS vaccine, something that couldpotentially save millions of lives throughout the world.It was a tantalizing prospect.

But Nabel could not say yes right away. Hiswife, Elizabeth Nabel, is a well-known cardiologistwith her own laboratory and clinical duties at theUniversity of Michigan, where Gary Nabel himselfwas director of the Center for Gene Therapy. Theyhave juggled two careers ever since they met asinternal medicine residents at a Boston hospital, andit was only after Elizabeth Nabel was offered aposition at NIH’s National Heart, Lung, and BloodInstitute that the Nabels and their children headedeast. Nabel says that his favorite leisure activity isbeing with his family, and he wanted everyone tobe happy with the move.

Although an article in Science described himas “a relative newcomer to AIDS vaccine work,”Gary Nabel is hardly a stranger to HIV research orto the ways of the NIH. Nabel went straight fromHarvard College to a joint M.D.-Ph.D. program atHarvard Medical School. “I knew that I wanted todo medicine, but I also wanted to do science,” herecalled. “It was something I decided very early on.”He studied immunology in graduate school,completed an internal medicine training program inBoston, and in 1985 became a postdoctoral fellowin David Baltimore’s virology lab at the WhiteheadInstitute at the Massachusetts Institute of Technology.

This postdoc put Nabel in the vortex of AIDSresearch. Baltimore was not only a Nobel laureate,the founding director of the Whitehead, and an experton HIV and other retroviruses, he was also in theinnermost circle of the scientific establishment. In1986, for example, he chaired a blue-ribbon Instituteof Medicine panel that assessed the overall state ofAIDS research. His lab launched the careers ofmany outstanding young scientists, and Nabel wasamong them. At the Whitehead, Nabel exploredhow HIV subverts the machinery of T-cells,published impressive papers, and went to seek hisfortune in Ann Arbor.

Gaining something intranslation

At Michigan, Nabel began to inject foreigngenetic material directly into human tumors, in hopesof inducing the patient’s immune system to attackthe cancer. When preclinical studies showedpromise, he arranged for Vical, a San Diego-basedbiotech company, to package the genetic materialin tiny lipid beads called liposomes. (In the world ofHIV vaccines, Vical is better known for the DNAvaccine technology it licensed to Merck.)

Nabel soon discovered that moving a radical

new therapy into humans is no easy task. “I wrotethe clinical protocol, I wrote the IRB (request toexperiment on humans) and the FDA application,we developed the production process, I went downfor the IND (Investigational New Drug) meetingswith the FDA, I treated the first patient, I even wrotethe informed consent,” Nabel recalls, sounding gladto have done this but relieved that it’s over. “I sawevery aspect of what’s needed to bring somethingforward into a clinical study, and I learned from that.”This product is now being tested in a Phase III studyenrolling patients with advanced melanoma, and in aPhase I trial with head and neck cancer patients.

Bridging the gapsAlthough Nabel has never designed an HIV

vaccine, his lab is working on a vaccine for Ebolavirus. More relevant to the VRC’s mission is his“translational” experience with gene therapy. Nabelhopes that the VRC will remove stumbling blocksfrom the path of vaccine developers. Some vaccineefforts, for example, are stymied when theiracademic inventors don’t have the resources to maketest batches. Other ideas languish in the labs ofcorporate scientists, who must put all their energyinto the company’s lead technology instead ofexploring new approaches.

The VRC will enable vaccine scientists “tosee it through,” an opportunity that he hopes willlure new talent to the enterprise. Instead ofreorganizing long-time NIH personnel, Nabel hasthe go-ahead to recruit about 100 full timeemployees, including researchers and support staff.Completion of the Dale and Betty Bumpers VaccineResearch Center, honoring the former Senator fromArkansas and his wife is expected in August 2000,and the facility will provide containment facilities forhandling dangerous organisms, a small GLPmanufacturing facility for making test batches, anda research group focused on developing assays forclinical trials. These resources can be used to helpresearchers elsewhere at NIH, in academia, or incorporate settings. The point is to keep promisingideas from withering on the vine.

Research agenda evolvingNabel and his new scientific team will be

closely watched as they set their scientific priorities.Nabel reports to an executive committee of topNIH administrators, including not only NIH directorVarmus but also Tony Fauci of the National Institutefor Allergy and Infectious Disease and RichardKlaussner of the National Cancer Institute. TheVRC also answers to an intramural scientific boardand to an external advisory committee that willprobably be an offshoot of the AIDS VaccineResearch Committee. David Baltimore, Nabel’sformer mentor, chairs the AVRC.

Fortunately, Nabel is no stranger to the worldof NIH committees. He was a member of theNIAID’s AIDS Research Advisory Committeefrom 1993 to 1997, and chaired the group duringhis final year of service. In 1994, Nabel was amongthe majority of ARAC members who voted not toexpand clinical testing of the recombinant gp120vaccines owned by Chiron and Genentech (nowVaxGen). Over the years he’s kept track ofcandidate vaccines for HIV, and expects the VRCto throw its early support behind combinationstrategies that appear to elicit both antibodies andCTL-activity. In the long run, Nabel expects goodresults from DNA vaccines or live vectors.

Gary Nabel: Vaccine Research Center Head Rises to Challenge

Gary Nabel directs thenation’s first AIDSVaccine ResearchCenter.

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SABIN VACCINE REPORT February 2000 5

Nabel wants the VRC to play an active rolein developing vaccines for the world, not just theUnited States. Although there are clear geneticdifferences among HIV subtypes from differentparts of the globe, “it’s still an open question whatthese differences mean in terms of immuneresponses,” Nabel said, vowing that the VRC willhelp back international clinical trials. Africa and otherparts of the developing world are suffering mightilyfrom the AIDS pandemic, and the U.S. shouldsupport international trials mainly because “ it’s justthe right thing to do.”

While the pursuit of a vaccine that can protectmillions against AIDS is the central mission of theVRC right now, “I hope that we’re going to bedeveloping, as much as possible, a set of rules orlessons that we can apply to other vaccines,” Nabelsaid. There’s every reason to expect that newepidemics are waiting in the wings, and Nabel hopesto be better prepared when they step onstage. v

Patricia Thomas was editor of the Harvard HealthLetter from 1991to early 1997. Since then, she hasbeen at work on a book about the search for an AIDSvaccine, which will be published in 2001 by PublicAffairs. Thomas was among the earliest healthy vol-unteers to be injected with an experimental DNAvaccine for AIDS, in a National Institutes of Healthtrial conducted during 1997 and 1998.

given by Shao at the meeting. The next group inwhich HIV was identified was intravenous (IV)drug users in Yunnan Province who injected pureheroin. Cases also were identified along China’scoast and in its large cities.

Yunnan, in southwestern China, adjacentto the Golden Triangle region of Myanmar(formerly Burma), currently has the highest HIVinfection rate in the country. According to HeheCheng of the Yunnan Center for AIDSPrevention, Care and Research in Kunming,89.3% of the people from Yunnan infected withHIV are IV drug users s.

Molecular epidemiological evidenceindicates that the infection spread in anortheasterly direction into Sichuan Province, theneastward into Hebei and Henan. It also spreadnorthwest from Sichuan, into Gansu and Xinjiang.Xinjiang, in the far northwest of China, isestimated to have between 15,000 and 25,000people infected with HIV, according to YuanzhiZhang, director of the Center for AIDS Detectionand Supervision, Station of Hygiene andEpidemic Prevention of Xinjiang UygurAutonomous Region. Ninety-seven percent ofXinjiang’s 2,341 diagnosed cases of HIVinfection are IV drug users. S h a oexplained that almost all known subtypes of theHIV-1 virus have been found in China, althoughthe majority of cases are B’ and C. A unique C/B’ recombinant strain has been traced throughits transmission via the drug trafficking routes fromsouthern China north to Xinjiang, where it is theonly strain of HIV found. HIV has been identifiedin samples from all of China’s provinces andautonomous regions. Recently, several cases ofHIV-2 were identified in Shanghai, Shao noted.

The question the Chinese now confront—and which they posed to the meetingattendees—is how China can best interface andcooperate with researchers worldwide to stopthe spread of HIV before the country faces an

China Holds First International HIVVaccine Workshop

BY MYRNA E. WATANABE, PHD

On November 18-23, 1999, the NationalCenter for AIDS Prevention andControl (NCAIDS), Chinese Academy

of Preventive Medicine, Ministry of Health, andMinistry of Science and Technology of thePeople’s Republic of China hosted their firstInternational AIDS Vaccine Workshop. Nearly40 foreign scientists and about 70 Chineseresearchers, clinicians, government officials,graduate students, and post-doctoral studentsattended the workshop. The goals of the meetingwere to introduce foreign HIV research toChinese scientists, especially those unable totravel extensively, and to introduce the data Chinaalready has compiled on its growing HIV problemto the international scientific community.

The meeting began in Beijing and endedwith a trip to Yunnan Province to visit a vaccinemanufacturing facility and a primate facility andto meet Chinese HIV patients. The dogged workof Yiming Shao, deputy director of NCAIDS,and his colleagues yielded significant internationalsupport. The foreign sponsors included the JointUnited Nations Programme on HIV/AIDS, theUS National Institutes of Health (NIH), theEuropean Union, the International AIDS VaccineInitiative, the Henry M. Jackson Foundation, andNIH funds via Harvard University and theUniversity of North Carolina-Chapel Hill.

Chinese epidemiologists estimate thatthere are 400,000 people infected with HIV inthe country. By the end of September 1999,15,088 cases of HIV infection were identified.As of that date, a total of 240 deaths in Chinawere attributable to AIDS.

HIV was first identified in China in themid-1980s in hemophilia patients who receivedcontaminated factor VIII (a blood-clotting factorthat is given to hemophiliacs), in severalforeigners, and in a few (people of Chineseancestry who live abroad, according to a paper Continued on page 5

SOURCE: Professor Yiming Shao, National Center for AIDS Prevention and Control (NCAIDS)Beijing,PRC

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6 SABIN VACCINE REPORT February 2000

The Albert B. Sabin Vaccine Institute and the Medical Helminthology Laboratory at Yale University under Dr. Peter Hotez have workedand collaborated extensively with China since 1994, and more recently with India. Reprinted below are two examples of how urgent thehookworm problem is and how desperate medical personnel from these countries feel in regards to the disease. The following letters were

instrumental in securing funding to make a vaccine against hookworm possible.

Testimonials Bring Deeper Meaning To the Burden of Hookworm

Hookworm infection is a majorpublic health problem in the ruralareas of our country. Based on

a nationwide survey between 1988 and1992 organized byour Ministry ofHealth, we haddetermined that theoverall prevalenceof hookworm is17%. This numberis based on1,477,742 fecalexam ina t i ons .Therefore wecalculated thatthere are anestimated 194

million cases of hookowrm. Over the lastdecade, the prevalence of hookwormhas decreased in some areas whereaggressive economic reforms haveoccurred. The best example of this is insuburban areas of Jiangsu Province whichare close to the large cities, includingShanghai and Wuxi. This study waspublished together with Peter Hotez in theSoutheast Asian Journal of TropicalPublic Health (September 1998).

However, in the highly rural areas ofHainan, Sichuan and even AnhuiProvinces hookworm continues to be a

major health threat. Working withPeter’sgroup we published papers this year inActa Tropica (in press, 1999) whichshow that the prevalence and intensity ofhookworm is the same or even higher thanit was 10 years ago! There are severalreasons for this, including the continueduse of human feces as fertilizer andinadequate sanitation. This is essentiallythe situation in this part of China forhundreds of years. In the absence ofaggressive economic reforms in theserural areas, it is not reasonable to expectthis situation to change anytime soon.Therefore we anticipate that hookwormrates will decline only in suburban areasclose to major cities.

Unfortunately, albendazole and otheranthleminthic drugs are not adequate forcontrolling hookworm in these rural areas.Unless we administer the drugs several timesa year, the people remain infected with notonlyhookworm, but also ascariasis as well.However, it is usually not possible to administerthe drugs to large populations on this frequentbasis. Therefore the people remain infected.Now we are also worried about anthleminthicdrug resistance, especially to albendazole.

In many ways the problem ofhookworm is similar to the problems ofmany helminth infections in China,including schistosomiasis. For that reason,

we are working with Dr. Hotez’s groupto develop an alternative strategy throughanti-hookworm vaccination. This is a newidea, but one which we are excited about.A successful vaccine could prevent theproblem of rapid reinfection which occursalmost immediately several months afteranthelminthic chemotherapy, and wouldhelp us lessen use of anthelminthic drugs.Therefore use of an anti-hookwormvaccine might also help us preventemerging drug resistance. We couldanticipate using a vaccine as part of anoverall anti-helminth control strategy.

Therefore we at the Institute of ParasiticDiseases, which is the major parasitic diseasecomponent of the Chinese Academy ofPreventive Medicine, hope that you willseriously consider the Hookworm VaccineInitiative proposal submitted by Dr. Hotez. Weanticipate that our Institute will continue tocollaborate closely with Peter on this project.As you may know, there are not many U.S.scientists like Dr. Hotez who have thecommitment to work with institutes such asours to solve problems in developing regionsof Asia. We greatly enjoy working with Peter.

Sincerely,Feng Zheng, ProfessorInstitute of Parasitic DiseasesChinese Academyof Preventive Medicine

A Letter From India:Hookworm Weakens an Already Impoverished Nation

A Letter From China:Experts Hope For a Vaccine To Combat Emerging Drug Resistance

major public health problem. Drugs areavailable but are cost prohibitive. Thepeople who are infected are extremelypoor and cannot afford the cost ofmedicinesin view of repeatedreinfections in endemic areas. So thereis a pressing need for vaccines that canprevent hookworms from penetratingand establishing in the gut, a normal sitefor the parasite.

It is unfortunate that the problem ofhookworm infection has been ignored bypublic health officials in this country asthe disease does not cause instant death.[Nevertheless,] the hookworm diseaseundoubtedly is one of the majorimpediments in the socio-economicprogress in India and warrants immediateattention for containment of the parasite.

With warmest regards,

DR. H.G. SENSenior ScientistHindusthan CIBA-GEIGY

Theproblemof hookworm disease inThird World countries has been thesubject of investigation for several

decades. It perhaps outranks all otherworm infections of human misery, debilityand morbidity. In India more than 130million people are infected withhookworms due to either Ancylostoma

duodenale orN e c a t o ramericanus orboth. The formerparasite, a morevirulent pathogen,is distributedexclusively in thenorth while thelatter is prevalentin the rest of thecountry.

Both parasitesare voraciousblood suckers as

each one sucks 0.1 to 0.2 ml of blood perday. The vast majority are the sameindividuals who suffer from malnutrition,lethargy and poverty. The highest incidenceof infection is in wet areas and in coalmines.The epidemiological study in India revealsthat the 15 to 20 year age group iscommonly infected and a larger segment ofthis population have enough worms to causeclinical symptoms of anemia, loss of vitalityand chronic illness.

Though the disease is never spectacularlike some other diseases but is essentiallyinsidious year after year, generation aftergeneration and undermines the health andefficiency of whole communities. Sincethere are hardly any sanitary indoor toiletsin homes, people have the habit of releasingthemselves in open fields where hookwormeggs are discharged with faeces.

In course of time they pick upinfection and reinfection from their owncontaminated environment which is a

“Though thedisease is neverspectacular likesome otherdiseases but ise s s e n t i a l l yinsidious yearafter year,generation aftergeneration andundermines thehealth andefficiency of wholecommunities. “

A successfulvaccine couldprevent theproblem of rapidreinfection whichoccurs almostimmediatelyseveral monthsa f t e ranthelminthicchemotherapy.

SABIN VACCINE REPORT February 2000 7

Few Lured To Study Hookworm Despite ItsGlobal Prevalence

BY CHARLENE A. FLASH

“As it was when I first saw it, so it is now, one ofthe most evil of infections. Not with dramatic

pathology as are filariasis, or schistosomiasis,but with damage silent and insidious. Now thatmalaria is being pushed back (sic) hookwormremains the great infection of mankind. In my

view it outranks all other worm infections of mancombined... in its production, frequently

unrealized, of human misery, debility, andinefficiency in the tropics.”

In the 1960’s Professor Norman Stoll ofthe Rockefeller Institute eloquently described thedisease burden caused by hookworm in anaddress to the New York Society of TropicalMedicine. Four decades later hookworms infectmore than 1.3billion peoplein Asia, Africaand SouthA m e r i c a ,haunting thew o r l d ’ sp o o r e s tchildren andconsigningthem to livesmarred bystunted mentaland physical development. Hookworm bearsthe dubious distinction of being the second mostprevalent infection of humans; nevertheless, only

two laboratoriesin the entire worldare exploringsolutions onebeing the MedicalHelminthologyL a b o r a t o r ydirected by Dr.Peter Hotez,chair of the

Scientific Advisory Board of the Albert B. SabinVaccine Institute. His lab is on the front lines ofbattle as the search for an anti-hookworm vaccinedraws ever closer to success.

I ttakes au n i q u eindividual tospearheadthese typesof efforts,and one isfound in Dr.P e t e rHotez. AsDr. PeterH o t e zgraciouslyacceptedthe 1999H e n r yB a l d w i nWard Medal from the American Society ofParasitologists, he shared his earliest scientificpursuits when as a child he would look at themurky waters of a nearby pond under hismicroscope and marvel at the wonders he saw.In that watery microscopic world he encountereddaphnia and learned of their symbiotic

relationship with ducks and geese.

The complexities of symbiosis wouldcontinue to intrigue Dr. Hotez, as his scientificpursuits for the next three decades focused onworms and parasites. At age fourteen, Dr. Hotezvolunteered at the Connecticut State Departmentof Health compiling records of parasite incidencein fecal samples. In high school he studiedearthworms. In college he analyzed the proteinsof a parasitic worm specific to the Africancontinent. Dr. Hotez received both his medicaldegree and his PhD from R RockefellerUniversity, and it is there that he began studyinghookworms in particular.

Labeled the “germ of laziness,” hookwormis indescribably debilitating even though it does

not yield thed r a m a t i cc l i n i c a lmanifestationof Ebola virusor HIV.When theseworms attachtheir teeth-l i k eappendagesto the wallsof their

intestinal homes in a human host, hemorrhagingresults. Hookworms cause chronic blood lossand thus anemia and protein deficiency; theyinhibit physical development in children and retardintellectual development. The large-scale socialaffects hookworm infections have on educationand economic progress explain hookworm’sability to quietly cause the deterioration of entirecommunities.

Charles Wardell Stiles, one of the earlychampions in the battle against hookworm playeda key role in eradicating hookworm from theSouthern United States. In the internationalarena, the solutions Stiles discovered and helpedimplement will not work because they requirechanges in agricultural, religious and social

practices inC h i n a ,India, ands u b -S a h a r a nAfrica thathave beeningrainedf o rdecades.Hookworm’saffects canbe bestnullified byimplementationof an anti-hookwormvaccine in

tandem with improved sanitation, use ofantihelminthic drugs, and new fertilizationtechniques.

Charlene Flash is a research fellow at the AlbertB. Sabin Vaccine Institute and Editor-in-Chief ofthe Sabin Vaccine Report.

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Ancylostoma Duondenale (l) and Necator Americanus (r) are the mostprevalent species of hookworm found on the continents of South America,Africa, and Asia. Necator Americanus is also found in Australia.

Dr. Peter Hotez’s Medical Helminthology Laboratory has committedthemselves to developing an antihookworm vaccine.

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Labeled the “germ oflaziness,” hookworm isindescribably debilitatingeven though it does notyield the dramatic clinicalmanifestation of Ebolavirus or HIV.

Hookworm Glossary

Helminthology: the study ofparasitic worms.

Nematodes: a zoological phylum ofworms. These include parasitic andfree-living species. Therefore it isfrequently qualified to talk about“parasitic nematodes” or “intestinalnematodes.”

Ancyclostoma: one of two generaof human hookworms. The other isNecator.

Necator: one of two genera ofhuman hookworms. The other isAncyclostoma.

Albendazole: a majorbenzimidazole drug used for treatinghookworms.

The other is mebendazole.

Eukaroytes: organisms with a

Hookworm Glossary

China Aids Conference (cont’ from page 5)

extremely serious problem. Vice Minister ofHealth Da-kui Yin invited foreign assistance:“I welcome everyone to enhance ourcommunication and collaboration in thisfield.” He asked, “Why don’t we cooperatetogether and contribute to this importantwork?” The important work includesdevelopment of vaccines against HIV.

China already has several ongoingprojects to develop HIV vaccines. Shaonoted that among these are: 1) constructionof virus-like particles from HIV-1 subtypesB’, C, C/B’, and E that have been placed ina baculovirus system and were expressed ininsect cells (in cooperation with Universityof Regensburg, Germany); 2) using yeastsystems to express HIV proteins; 3)development of a DNA vaccine (gp120 andgag p55 clones in a DNA vector) (also incooperation with University of Regensburg);4) development of a vaccinia virus vector(Tiantan strain); 5) development of a fowlpox vaccine expressing subtype B’, C, C/B’, and E; and 6) development of anadenovirus expressing B’, C, C/B’, and E.

China also has facilities for testingvaccines in primates and for vaccineproduction. The country’s main problemsare financial resources. The Chineseresearchers and administrators hope thatwith this meeting, foreign researchers will seethe opportunities for joint research, clinicaltrials, and epidemiological monitoring in acountry that has good science andtechnology, a good public health andepidemiology infrastructure, largepopulations for clinical trials, and acommitment to HIV vaccine development.

8 SABIN VACCINE REPORT February 2000

WHO, UNICEF, CDC, Rotary Intensify Polio Eradication Effortsduring National Immunization Days (NIDs),

c) acute flaccid paralysis surveillance wherebyevery single case of child paralysis must be investigated,and

d) “Mopping up” immunization activities whichare in place to re-immunize children in high-risk areas.

The last case of polio in the Western hemisphereoccurred in Peru in 1991 and in the Western pacific

region in Cambodia in 1997.There were only 6000 cases ofpolio reported world-wide in1998 which represents a decreaseof 85 percent of cases ascompared to the 350,000 casesreported in 1988. Althoughsignificant progress has beenmade to date, there are still threemajor reservoirs where poliotransmission occurs: South Asia,West Africa, and Central Africa.Forty-eight countries are presentlyknown or suspected to beendemic, and recent poliooutbreaks such as those in Angolaand Eastern Europe call for anintensification of eradicationactivities. The Polio EradicationInitiative has in particular identifiedIndia, Bangladesh, Pakistan,

Sudan, Somalia, Democratic Republic of Congo(DRC), Ethiopia, Angola, Afghanistan and Nigeria aspriority countries.

In its final and most crucial phase, the majorchallenges in the initiative have been identified asstopping polio transmission in endemic countriesespecially those in conflict, and strengtheningsurveillance and laboratory networks. To achievethe termination of transmission, WHO urges itsmember nations to improve vaccine coveragebeyond the already impressive rate of nearly 90percent. They are advocating, “Immunizing everychild because every child counts.”

Rotary International, a nonprofitorganization which has played a leading rolein polio control, addressed Gro HarlemBrundtland, the WHO’s Director-General, tooffer its 1.4 million volunteers as “foot soldiers”in the eradication effort. Dr. Brundtlandwarned, “One of the paradoxes of aneradication initiative is that control efforts mustbe intensified as the disease disappears. Weneed to accelerate house-to-house delivery ofthe vaccine ... and continue negotiations with

warring parties, and we need to improvesurveillance systems so that every paralyzedchild is investigated for polio and we canconfidently say that countries, regions, andeventually the entire world are polio-free.”

To address the changing needs of theinitiative in the last and final phase of eradication,a new set of priorities were identified during the1999 meeting of the Social Mobilization AdvisoryGroup for Polio eradication which includedUNICEF, WHO, Rotary International, Basics,Change, Voice of America, CDC, USAID, WorldBank, ARCH (Harvard University) and PCS(Johns Hopkins University).

The need toimprove the quality ofNational ImmunizationDays was discussedand it was determinedthat in order to obtaina better understandingof the immunizationstatus of a region anddeliver vaccinescomprehensively, dis-aggregated data oncoverage needed to be generated so thatpopulations with inadequate coverage can beidentified. This would improve the accuracyof the target population and enableimmunization efforts to be more focused. ,Additional efforts focus on giving children inregions of conflict access to immunization,increasing support for the ten priority countries,and improving surveillance methods.

The number of worldwide cases of poliohas dropped by almost 90% since thecampaign began 10 years ago. The greatmajority of countries are already polio-free,and the 6,415 confirmed cases in 1999 camemostly from the Indian subcontinent and sub-Saharan Africa. From now on, WHO hopesto investigate each singular case to betterunderstand the specifics around the infection.Specific populations have been targeted andsurveillance efforts have increased. Withcontinuing effort on the part of WHO and otherhealth and volunteer agencies, a polio free worldseems possible within the next three years if notthe next 11 months.

Remembering Polio: Karen Veronica Recalls the Polio Scourge

BY NISHIENA GHANDI

Global polio eradication as defined byWorld Health Organization (WHO)involves the complete interruption of

wild polio transmission. Efforts to achieveeradication by the year 2000 have beenunderway since the late 1980s. In fact, the PolioEradication Initiativewas launched in May1988 at the WorldHealth Assembly’sannual meeting inGeneva. At that timethis governing body ofWHO resolved toeradicate polio fromthe world by the year2000. The success ofthis initiative, however,depends oncollaboration of manypublic and privatepartners, including theUnited Nation’sChildren’s Fund(UNICEF), whichprovides the oral poliovaccine; the U.S. Centersfor Disease Control and Prevention, which offerstechnical expertise; and the service organization RotaryInternational, whose 1.2 million members in 159countries have made polio eradication the main focusof their fund-raising and volunteering.

The polio eradication initiative is currently in itsfinal and most crucial phase. Although some observershave suggested that the campaign may take until 2003to eliminate paralytic polio,the World Health Assemblydelegates and two independent expert advisory groupsto WHO, The Global Technical Consultative Groupfor Polio Eradication and the Scientific Advisory Groupof Experts at their 52nd annual meeting in May 1999 inGeneva, Switzerland, asserted that “establishederadication strategies, when fully implemented, willachieve eradication by the target date.” Acceleratingefforts in reservoirs such as Angola and Bangladeshmake eradication by the end of the year 2000 is still areasonable goal.

The strategy developed by WHO and itspartners to eradicate polio is four-pronged:

a) a strong routine immunization program via theeffective and inexpensive oral polio vaccine,

b) supplementary additional doses of OPV

The iron lung was used in the first half of the centuryto enable paralyzed polio vistimes to breathe.

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Nishiena Ghandi is a Master’s Candidate at theYale University School of Public Health.

In these first months of the new year,those of us trying to clean up and clean outencounter memorabilia of days long gone.Karen Veronica, Executive Director andFounder of an HIV/AIDS hospice inConnecticut called Bread & Roses, chancedupon a single wrinkled sheet documenting theday she received her polio vaccination. Ms.Veronica remembers the seemingly never-ending line outside the newly constructedJunior High School in her home town ofBerea, Ohio population 20,000, where hersiblings, parents, and neighbors patientlyawaited their turn to take the contents of alittle white cup holding the precious white

cube containing the Sabin oral polio vaccinedose. After the days when the townspeoplelined up for their sugarcubes, she recalls theybreathed a “collectivesigh of relief.”

During that post-World War II era, ageneral sense of fearcloaked adults andchildren alike with thebeginnings of the ColdWar and the shroud ofinfectious diseases likeinfluenza and polio.

Foremost however was the fear of Polio. Inthose days, “People were always thinking

about it,”according to Ms.Veronica. Duringthe hot summersparents, rich andpoor alike,restrained theirchildren fromswimming for fearthey mightcontract thisdreaded viralillness by ingesting

BY CHARLENE FLASH

Mia Farrow, actress and mother of a son withpolio, speaks at the Progress of Nations at theUN in 1999.

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Although significantprogress has beenmade to date, thereare still three majorreservoirs wherepolio transmissionoccurs: South Asia,West Africa, andCentral Africa.

SABIN VACCINE REPORT February 2000 9

this disease predominantly afflicts not only thepoorest countries in places regions as sub-Saharan Africa, but in particular the poorest ofthe poor in these developing nations. What thenis the incentive for major vaccine producers toinvest the hundreds of millions of dollars in R&D,manufacture and post-license marketing thatwould be required to produce an anti-malariavaccine? Case studies presented for not only

malaria, but also HIV, dengue fever andhookworm infection illustrated over and overagain that “business as usual” would never result

in thesuccessfuldevelopmentof vaccineto fightt h e s edevastatingillnesses.

Thus,although it

is now possible to apply modern techniquesdeveloped by academia and the biotechnologyindustry to make vaccines for these ancient andemerging scourges, we now find ourselves in anunusual and distressing situation. Our technicalabilities to employ modern biotechnology for themanufacture of these desperately neededvaccines have outpaced our vision. Ourtechnology is exceeding our wisdom. This isoccurring at several different levels, regarding the

issues of R&D, payment structure andmacroeconomics. Yet for the most part, our politicaland spiritual leaders, our legal and medical scholars,our ethicists and artists, have remained silent aboutour ability to combat the great plagues of AIDS, TB,malaria, dengue, hookworm. In this sense there is aconspiracy of silence. Our colloquium attempted tobreak the conspiracy of silence about developmentof vaccines for the great neglected diseases of

humankind, such as AIDS, TB,malaria, dengue, hookworm. Thismeeting broke the silence.

The colloquium reaffirmedthat combating infectious diseasesmust be accorded a central role ininternational strategies for improvedpublic health, poverty reduction,and economic development in theheavily indebted poorest countries(HIPCs). A number of novel pushand pull funding strategies wereoutlined to provide mechanisms bywhich to solve these issues. Thesewere put forward with some urgencybecause of a series of key actionsanticipated in the YR 2000. Theseinclude finalization and submission toCongress of the FY 2001

Administration budget; parliamentary budget cyclesin Europe, Japan, and Canada; a White Housemeeting early next year, following up on PresidentClinton’s U.N. address this Fall; ongoingpreparation for the G-7 Summit in Japan in June2000; a planned Summit of African Leaders onMalaria next Spring to be hosted by Nigeria andsupported by the WHO; the launch of the enhancedHIPC initiative on debt relief; decisions by theExecutive Board of the World Bank.

The Colloquium has launched a concertedeffort by the pharmaceutical industry, GAVI, andother participants to work intensively over the nextyear. Extraordinary interdisciplinary leadership ofvision and wisdom is needed to seize this uniqueopportunity and find solutions. Our goals will beto ensure that an expanded global vaccine effortis brought to fruition.

International Leaders Seek Solutions to Developing World Challenges

BY PETER HOTEZ

While most of us think of December7 as a day that will“live in infamy” because of its

association with the bombing of Pearl Harbor, in1999 that date also witnessed a remarkable dayof human compassion. Between December 5 and7 last year, the Sabin Vaccine Institute held acolloquium at Cold Spring HarborLaboratory, which brought togetherleading economists, international healthpolicy experts, philanthropists, vaccinemanufacturers, and physician-scientistsin order to tackle one of our greatestsocial challenges - namely how will weafford the next generation of vaccinesfor developing countries. Over thesetwo days an extraordinary team ofexperts selected from such diverseorganizations as the White House Officeof Science and Technology, the U.S.Treasury Department, the NationalSecurity Council, World Bank,UNICEF, Global Alliance for Vaccinesand Immunization (GAVI), WHO,

InternationalA I D SVaccine Initiative (IAVI),GAVI, WHO, IAVI, theBill and Melinda GatesFoundation, economicthink tanks, leadinguniversities, and majorprivate sectorrepresentatives from

Merck, Wyeth, SmithKline Beecham, and GlaxoWellcome debated and explored innovativesolutions for a pressing issue that will affect hundredsof millions of children in less developed countries.

The problem we focused on was how wecan encourage the development of desperatelyneeded vaccines for which the markets either donot exist or are grossly inadequate. For instance,falciparum malaria kills an estimated 1-2 millionchildren under the age of 5 every year. This diseaseis arguably the single leading killer of youngchildren in the world. The biotechnology is nowavailable to begin making a serious attempt todevelop a safe and effective malaria vaccine. Yet,

Cold Spring Harbor Colloquium Tackles the Issue of Affordable Vaccines

Peter J. Hotez is the director of the Medical Hel-minthology Laboratory at Yale University and isalso an Associate Professor at the School of PublicHealth and Epidemiology .

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water contaminated by infected feces.Ms. Veronica chuckles as she

remembers preparing for her family vacationto northern Michigan by picking out an extrabathing suit— an extravagance at other times— but a necessity because she was notallowed to even sit by the crystal clear lakein a wet bathing suit. Though she could notunderstand how the crystal clear waters ofthe lake could hold anything infectious orbad, she was excited at the prospect of anew bathing suit.

In about the fifth grade one of Ms.Veronica’s classmates contracted polio.News spread through her community as pity

for his parents and siblings filled each house.Although he left school, the constant hum ofconversation about his ailment made his presencefelt. “That’s all we talked about. We all sentcards.” Paralysis of individual muscles is one ofthe symptoms of polio, and a few years later hereturned to school with a “bad limp.” Many of herfriends did not know how to approach the topicof his limp, the calling card of his bout with polio.It was a tragic curiosity. He and his family latermoved away from Berea.

The actual vaccination process stands out inMs. Veronica’s memory as one of her best publichealth experiences. She recalls her poliovaccination as a positive experience among a host

of negative health encounters such as beingtreated as a second-class citizen when going infor STD testing. This experience was proactive,clean, upbeat, all-inclusive and it made sense.Most importantly it erased the fear.

Now as executive director and founderof Bread & Roses, Karen Veronica strivesto create positive health experiences forpeople suffering with HIV or AIDS. Sheand her staff “walk alongside people withAIDS, through direct care, education,outreach and advocacy.”

Our technicalabilities to employmodernbiotechnology for themanufacture of thesedesperately neededvaccines haveoutpaced our vision.

The colloquium reaffirmed thatcombating infectious diseasesmust be accorded a central rolein international strategies forimproved public health, povertyreduction, and economicdevelopment ...

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Dr. Peter Hotez (left) of Yale University and Dr. Jeff Sachs (right), Director ofthe Center for International Development at Harvard University, co-chairedthe colloquium at Cold Spring Harbor.

10 SABIN VACCINE REPORT February 2000

The Politics of InternationalHealth:

Children’sVaccine

Initiative andthe Struggle to

DevelopVaccines for

the ThirdWorldWilliam

Muraskin, StateUniversity of New York Press, 1998

BY VERONICA KORN

Published shortly before the controversialdissolution of the Children’s Vaccine Initiative (CVI)in March 1999, William Muraskin’s The Politicsof International Health: The Children’s VaccineInitiative and the Struggle to Develop Vaccinesfor the Third World is an in-depth exploration ofthat organization’s vision and effort to bring togetherthe private and public sectors to target vaccinedevelopment for the nations of the Third World.Muraskin’s predictions that the future of the CVIseemed precarious were accurate, as it turns out.Through many short and lively interviews andquotes, the author highlights the difficulties in thisprocess and the differences in the organizationalcultures of the key players.

Created at the World Summit for Children in1990, the CVI was born out of inspiration andhumanitarian vision on the cusp of a revolution inbiotechnology that would make vaccine productionmore affordable and carve out a place for vaccinesas a profit-making entity. Co-sponsored by theUnited Nations Children’s Fund (UNICEF), the UNDevelopment Programme (UNDP), the WorldHealth Organization (WHO), the World Bank, andthe Rockefeller Foundation, the CVI was a uniqueglobal coalition of public, non-governmental, andprivate organizations. Its original goal was todevelop a single oral vaccine that could be given tonewborns shortly after birth to prevent more thantwelve deadly diseases. Vaccines are the leastexpensive and most effective means of diseaseprevention against many infectious diseases that still

ravage children of the Third World.When formed in 1990, the CVI was intended

to act as a facilitator in the product developmentaspect of vaccine research, especially on theinternational level. Immunization efforts in the ThirdWorld were severely hampered by a communicationgap between the public and private sectors, and thefounders of the organization that would evolve asthe CVI hoped to bring together researchers,developers, and health networks. Muraskindescribed the process of vaccine development as“a disarticulation.” As he clearly explains in writingto both the scientific and the lay community:

…shelves of research facilities were filled withvaccines...not picked up as a usable commodity.[Health agencies] delivering vaccines…had littleinteraction with scientists or commercial interests.They are forced to work with whatever vaccinesthe other two groups [researchers and private sectordevelopers] have decided to work on.”

Although the coordination of a three-foldsystem that would involve researchers, developers,and those ultimately responsible for deliveringvaccines in the field was one of the CVI’s initialundertakings, the real impetus lay in involving thepublic sector more in vaccine product development.

Muraskin takes the reader on a journey throughthe private sector, beginning with the attitude ofcomplacency towards vaccines, despite theirpotential to change the face of the Third World, andthen describing the dawning realization that newbiotechnology would make vaccines very profitable.All the while, the author intertwines the role of thepublic sector in this process as it endeavored to putaside its suspicion of the private sector’s commercialinterests and the subsequent formation of the CVIfor a fascinating historical account.

Despite the unfortunate timing of the CVI’sorigins from an economic standpoint, as the worldeconomy entered a recession in 1990, Muraskinpoints out that its failures and frustrations were reallymore the result of decision-making and in-fightingamong the players in such health network giants asthe WHO and UNICEF. He describes the dissimilarcorporate cultures, personality clashes, and culturaldifferences that oftentimes fueled a heatedcompetition between the two agencies. Most vividly,he describes the absorption of the CVI into WHO,the ensuing struggle between the agencies, andWHO’s inability to reach the important private sector

once CVI was officially based inside WHO. Inaddition, Muraskin predicts what can best bedescribed as the slow death of the CVI once it wassubordinated by WHO. He writes:

“…CVI leaders believed WHO wasincapable of doing what the CVI did: [being]flexible…seizing opportunities, attractive to outsideagencies, working comfortably with the privatesector, seeking out the best people. The tendencyof WHO to subordinate expertise to equalrepresentation of nations and regions…differentiatedit from the CVI. The WHO’s corporate culture wassimply the wrong place for the CVI. In addition,groups [like] UNICEF would not financially supportprograms implemented by WHO.”

Indeed CVI Coordinator Roy Widdus wrotein the final issue of the CVI Forum, the organization’snewsletter (no.18, July 1999), that because WHOwas a public-sector agency, it could not “formallyintegrate” private partners into a true coalition, ashad been the initial vision of the CVI.

It seems almost inevitable that the CVI itselfwould eventually become something of the past.Muraskin’s work describes a relatively simplesolution to some international health problems: adiverse coalition cooperating to find and delivervaccines to the Third World, where immunizationrates are extremely low and disease rates areenormous. Yet, each chapter is filled with powerstruggles and competition among key internationalplayers with good intentions but without the abilityto play together as a team. Muraskin concludes hisbook by focusing on the far-reaching successes ofthe CVI: its legacy of stirring interest in vaccinedevelopment and production across the internationalhealth scene; the renewed interest of organizationslike WHO in taking on effective roles in health; theestablishment of the International Vaccine Institutein Seoul, Korea, which is wholly dedicated tovaccine research and development; and arevolutionary plan to coordinate the work ofprivate and public sectors involved in vaccineproduction from beginning (development) to end(delivery). The lessons learned from theendeavors of the CVI are thought provoking,especially when one considers the challenges ofimmunizing almost 4 million children who,without vaccines, will die annually from vaccine-preventable diseases.

Find out more about the Children’s Vaccine Ini-tiative at http://www.vaccines.ch.

Lessons learned; opportunities missed

BY JOHN M. CLYMER

The Albert B. Sabin Vaccine Instit1ute hasselected Raymond V. Gilmartin to receivethe 2000 Sabin Lifetime Achievement

Award and Mary Flake de Flores to receive theAlbert Sabin Humanitarian Award. The awardswill be presented at a black tie dinner on Wednes-day, May 31 at The Pierre Hotel in New York City.

Mr. Gilmartin is chairman, president andchief executive officer of Merck & Co., one ofthe principal vaccine research and developmentcompanies in the world.Mr. Gilmartin has investedheavily in vaccine research. During his tenure, Merckhas introduced the only vaccine that preventschickenpox, as well as vaccines against hepatitis Aand Haemophilius influenzae type B (meningitis).The company’s pipeline features vaccines to preventHIV/AIDS, human papillomavirus/cervical cancer,

and rotavirus, a major cause of acute diarrhea anddehydration in infants.

Mr. Gilmartin’semphasis on re-cruiting and re-taining a talentedworkforce hashelped Merck benamed the bestpharmaceuticalfirms to work forin the U.S. byFortune maga-zine.The theme for thedinner is “Cel-ebrating Health in

the Americas.” It will focus attention on the eradi-

cation of polio throughout the Americas, and theongoing campaign to eradicate measles from theWestern Hemisphere.

Merck is an established leader in solvinghealth problems in developing countries. AfterMerck discovered that one annual dose of itsMectizan® (ivermectin) drug prevents river blind-ness, it decided in 1987 to donate Mectizan® freeof charge to all people affected by river blindness.It formed a partnership of industry, nongovernmentdevelopment organizations, and nongovernment or-ganizations to help it distribute the drug in Africanand Latin American countries where river blind-ness is prevalent. The company donates approxi-mately six million doses of Mectizan® annually. And,it has created a donation and distribution model thatcan be used to address other disease threats.

The first lady of Honduras, Mrs. Flores,

Merck CEO and Honduran First Lady to Receive Sabin AwardsCelebrating Health in the Americas

Ray Gilmartin, Chairman,President and CEO of Merck& Company

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SABIN VACCINE REPORT February 2000 1 1

BY ALLAN GOLDSTEIN

Thirty of the leading U.S. cancerresearchers presented work at the 2nd

Annual Walker’s Cay Colloquium onCancer Vaccines that indicates we are on theverge of a major victory in the “war on cancer.”“We are seeing meaningful results in thedevelopment of weapons to treat and preventvarious types of cancer,” said Allan Goldstein,Chairman of Biochemistryand Molecular Biology atGeorge WashingtonUniversity School ofMedicine and a participantin the meeting. “Recentadvances in immunologyare now being applieddevelop novel to vaccinesfor cancers and the resultsare encouraging,” he said.

The goal of themeeting convened by theAlbert B. Sabin VaccineInstitute was to shorten the time needed totranslate scientific discoveries to meaningfultreatments for cancer. The work presentedthere “indicates that we are at the stage of finetuning therapeutic and prophylactic cancervaccines,” Goldstein observed.

A number of novel cancer vaccines usingcombinations of the patients own cancer and dentriticcells plus cytokines have now entered human trials,have shown remarkable regression of advancedtumors and restoration of anti-tumor immunity.These results provide proof of principle for a vaccineapproach to cancer treatment.

“Scientists in multiple disciplines have madeextraordinary advances in molecular biology andgenetics over the past few years,” Goldsteinobserved. “These advances have vastly increasedour understanding of the role of cellular componentsof the immune system and the soluble growth factorsand cytokines produced by T-cells, NK cells,macrophages and dendritic cells responsible forantitumor activity. This knowledge has resulted inthe development of novel cancer vaccines whichare now being tested humans,” he added.

That approach to treating cancer and thecolloquium’s impact on scientific progress were

underscored by Dr. Carl June, Director oftranslational research programs at the Leonardand Madlyn Abramson Family Cancer ResearchInstitute at the University of PennsylvaniaCancer Center. June, a participant in the 1999and 2000 meetings, reviewed a case in whichhe developed a new biochemotherapy for apatient with a recurrence of ovarian cancer inApril 1999. He incorporated experimentalmateriel developed and disclosed by other

participants inthe 1999m e e t i n g .June’s therapya p p e a r ssuccessful atthis juncture;the cancer is inremission andthe patient isp h y s i c a l l ya c t i v e .“Without thissharing of

unpublished data and information at last year’smeeting, I would not have known about thesebrand new therapies, so I could not haveincorporated them into this cocktail. Icontacted these investigators and they wereextremely helpful in sharing additional data andproviding materiel to me,” June said. His clinicalprotocol therapyhas just beenapproved for aPhase I trial inpatients withadvanced ovariancancer.

Formationof a vaccineb i o m e d i c a lc o n s o r t i u m ,which the SabinVaccine Institutehas advocated for several years, was discussedat the 1999 colloquium. This year, DennisPanicali, chief executive officer of TherionBiologics, reported on an industry-government-academia consortium formed by his company.Therion, a closely-held biotechnology company,

Cancer efforts at Critical Stage Show PromiseReport from Walker’s Cay Cancer Vaccine Colloquium

has several cancer vaccines in its R&D pipeline,most of which have produced encouragingresults in clinical testing. “No one can do italone,” Panicali said. “Every one of thepromising products in our pipeline is the resultof this consortium that allows the NIH,academic research centers and our companyto stick to our strengths and combine our bestefforts to develop effective cancerimmunotherapies.”

The Walker’s Cay Colloquium is a thinktank-style meeting. Ralph A. Reisfeld,professor of immunology at the ScrippsResearch Institute and co-chair of thecolloquium, said the meeting is “distinctive forits small size and its emphasis on lively, opendiscussion.” The colloquium atmosphereencourages free exchange of data andinformation about the latest advances beingmade in cancer vaccine design andimmunotherapy. Participants share unpublisheddata and conclusions in discussions that sparknew ideas and experiments.

The site of the meeting, Walker’s Cay, isa small island in the northern Bahamas ownedby Robert Abplanalp, chairman and chiefexecutive officer of Precision ValveCorporation. Richard Nixon was a frequentvisitor to Walker’s Cay during his presidency.The secluded tropical island provided solitudeas he pondered major decisions. He was atWalker’s Cay when he decided to commit theUnited States to a “war on cancer.”

The “war” began with enactment of theCancer Control Act of 1971 which greatlyincreased National Institutes of Health fundingfor cancer research. Elliot Richardson, secretaryof Health, Education and Welfare at the time,“directed [funds] into areas of basic researchthat offered significant promise of shedding lighton the fundamental causes of cancer” such inmolecular biology, he wrote in a 1999 letter toSabin Institute chairman H. R. Shepherd.Twenty-nine years later, that research is payingoff with experimental vaccines to prevent andtreat a variety of cancers.Allan Goldstein is a Professor and Chairman ofthe Department of Biochemistry and MolecularBiology at the George WashingtonUniversity inWashington, D.C.

will be recognized for leading both public and pri-vate efforts to prevent disease and improvehealthcare in Honduras. Her involvement in thisarena began in the 1970s, long before her husband’sJanuary 1998 election as president. She is an out-spoken advocate for immunization. Her leader-ship helped the XIX Vaccination Crusade in May1999 reach 95% coverage nationwide. She ob-tained a donation from Merck of one-third milliondoses of measles, mumps and rubella vaccine,which were used in the crusade.

Mrs. Flores formed Fundación María, anonprofit organization dedicated to amelioratingpoverty, and improving health conditions, educa-tion , recreation and sustainable development forHondurans. In the aftermath of Hurricane Mitchin October 1998, the foundation distributed hu-manitarian aid to people left homeless by the storm,

an effort led by Mrs. Flores.Currently, Mrs. Floresis raising private funds to build a children’s hospitalin the country’s capital, Tegucigalpa. She is founder

and honorary president of the Honduran Founda-tion for Children with Cancer. She donates the prof-

its of her book, Virgencita de Suyapa, tothe foundation.

“Mary Flake de Flores is a tireless advo-cate for better healthcare for Hondurans and allpeoples of Central America,” said Sabin VaccineInstitute chairman H. R. “Shep” Shepherd. “LikeAlbert Sabin, she is dedicated to preventing dis-ease. She rolls up her sleeves and does the heavylifting that is required to truly make a difference.”

Mr. Shepherd praised Mr. Gilmartin as “anextraordinary corporate leader who is focused onmore than meeting Wall Street’s expectations forthe next quarter. He has strengthened Merck’s com-mitment to preventive health care, investing in re-search, bringing innovative vaccines to market, andcreatively applying Merck’s resources to preventdisease in all corners of the world, rich and pooralike. Although Ray is young, he already hasestablished a legacy as an astute executive and aglobal citizen,” Shepherd said.

Victor J. Menezes, chairman and chief

Continued on page 12

Participants enjoy the surroundings at the Walker’s Cay

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A number of novel cancervaccines usingcombinations of thepatients own cancer anddentritic cells pluscytokines have nowentered humantrials...these resultsprovide proof of principlefor a vaccine approach tocancer treatment.

Mary Flakes de Flores, First Lady ofHonduras

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12 SABIN VACCINE REPORT February 2000

CYRO DE QUADROS RECEIVES SABIN GOLD MEDAL

sabin calendarThe Institute is not responsible fornon-Institute events listed below.

Dr. Ciro deQ u a d r o s ,director of thePan AmericanH e a l t hOrganization’sDivision ofVaccines andImmunization,will receive theAlbert SabinGold Medalfor his roles inthe eradicationof polio and

measles from the Western Hemisphere.“Ciro de Quadros is an extraordinarily apt

choice for the Sabin Gold Medal because he upholdsAlbert Sabin’s ideals and quest to conquer diseasewith vaccines,” says H.R. Shepherd, chairman of theSabin Vaccine Institute. “Dr. Sabin showed us that,just as viruses know no borders, vaccine research

and immunization can transcend politicalboundaries and tensions. Dr. de Quadroscontinues to blaze trails in vaccine diplomacy,working to make all peoples healthier and tobreak down barriers to peace.”

Dr. de Quadros earned his medical degreein 1966, and a master’s in public health in 1968.He joined PAHO in 1977 after working onsmallpox eradication in Ethiopia. He led polioeradication efforts in the Americas, from 1985to 1991 when Peru reported the last case ofpolio. Efforts continue to globally eradicate polioby 2003. PAHO, which also serves as theRegional Office for the Americas of the WorldHealth Organization, works to improve healthand living standards in the Americas.

Dr. D.A. Henderson, a 1999 Sabin GoldMedal recipient who led the successful globalsmallpox eradication program, will present theaward to Dr. de Quadros at the 3rd AnnualConference on Vaccine Research in Washington,D.C. on April 30.

“A consistent mission pursued through dynamicprograms,” is chairman H. R. Shepherd’s assessmentof the Albert Sabin Vaccine Institute. The Institutewas founded in 1993 to carry on Albert Sabin’scommitment to disease prevention throughimmunization. That is our guiding principal even asthe Institute evolves,” he explained.

Based in New Canaan, Connecticut since itsfounding, the Institute recently moved its Washingtonsatellite office from the Georgetown Universitycampus to Rockville, Maryland. The New Canaanexecutive office coordinates all researchadvancement, educational, and advocacy programs,and communications including the Sabin VaccineReport and the Institute’s World Wide Web presence.The satellite office headed by Dr. Philip K. Russell,the Institute’s founding president, supports theInstitute’s research advancement initiatives. Thesatellite office is located closer to the NationalInstitutes of Health and the Food and DrugAdministration in Maryland’s biotechnology corridor.

Sabin Institute Establishes Satellite Office inResearch Corridor

Fran G. Sonkin recently joined the SabinInstitute at its New Canaan headquarters as ExecutiveVice-President. Reporting directly to the ChairmanH.R. Shepherd, Sonkin will direct all major operationsof the Institute. She received her Masters inInternational Relations at Columbia University.

You may contact the Sabin Vaccine Institute atthe following locations and numbers:

Office of the Chairman58 Pine StreetNew Canaan, CT 06840Tel. 203-972-7907Fax 203-966-4763

Washington Office6290 Montrose RoadRockville, MD 20852-4163Tel. 301-231-7092Fax 301-231www..sabin.org

précis5 December – 7 December 1999Cold Spring Harbor Laboratories

Cold Spring Harbor, NY 11724-2213Compiled by

Charlene A. FlashResearch Fellow

Vaccines for Developing Economies,Who will pay?

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For your copy please call:203.972-7907 or fax 203.966-4763

email:veronica.korn@sabin.org

April 30, 2000Albert B. Sabin Gold Medal AwardsRenaissance Hotel, Washington, DC

DR. CIRO DE QUADROS,DIRECTOR OF THE PAN AMERICAN

HEALTH ORGANIZATION’SDIVISION OF VACCINES AND

IMMUNIZATION, WILL RECEIVE THE

ALBERT SABIN GOLD MEDAL FOR

HIS ROLES IN THE ERADICATION OF

POLIO AND MEASLES FROM THE

WESTERN HEMISPHERE.

October 5-7, 2000Cold Spring Harbor, NY

INTELLECTUAL PROPERTY IN APHILANTHROPIC WORLD

Sponsored by the Sabin VaccineInstitute and organized by Jeffrey

Sachs, M.D. Ph.D. and PeterHotez, M.D. Ph.D.

May 31, 2000Dinner to Honor Ray Gilmartin

Pierre Hotel, NY, NY

RAY GILMARTIN, CEO OF MERCK

PHARMACEUTICALS WILL RECEIVE

THE LIFETIME ACHIEMVEMNT

AWARD FOR HIS OUTSTANDING

CONTRIBUTIONS TO VACCINE

DEVELOPMENT.

July 5-8, 2000Washington, DC

Marriot Wardman Park Hotel34TH NATIONAL IMMUNIZATION

CONFERENCE

September 7-10, 2000New Orleans, LA

38TH ANNUAL MEETING OF THE

INFECTIOUS DISEASE SOCIETY OF

AMERICA

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