immediate#hypersensi0vity#reac0on#related#to#rabies#...

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Abstract

Immediate Hypersensi0vity Reac0on Related to Rabies Post-‐Exposure-‐Prophylaxis in Thailand with Subsequent Rabies Vaccine Change to Avoid Polygeline Vaccine Excipient with Successful Challenge and Treatment Tolerance in the United States

(1) Texas Children's Hospital, Houston, TX; (2)School of Medicine, Baylor College of Medicine; (3)Pediatrics, SecEon of InfecEous Disease, Baylor College of Medicine; (4)Immunology, Allergy, and Rheumatology, Baylor College of Medicine

J. Michael Beckham, Medical Student1,2; J. Chase McNeil, MD1,3,; Lenora Noroski, MD MPH1,4

•  According to the AAAAI, anaphylaxis is considered probable when the reacEon involves at least 2 systems (cardiovascular, respiratory, gastrointesEnal, dermatologic) within 4 hours of exposure

•  Anaphylaxis is considered possible if only 1 system is involved within 4 hrs, or at least 2 systems are involved aUer 4 hrs.

•  Therefore in our paEent, anaphylaxis was possible, but considered unlikely. However, the Emecourse and type of reacEon does suggest a Type 1 (IgE mediated) hypersensiEvity reacEon.

Types of Cell Culture Rabies Vaccines Available in Thailand and USA

Purified Vero Cell Rabies Vaccine

(PVRV)

Verorab (approved in Thailand)

Purified Chick Embryo Cell

Vaccines (PCECV)

Rabipur (approved in Thailand)

Rabavert (approved in

USA)

Human Diploid Cell Vaccine (HDCV)

Imovax Rabies (approved in

USA)

•  Rabies kills 26,000-‐61,000 people annually worldwide •  11th most deadly infecEous disease

•  Growth in internaEonal travel makes exposure to rabies and therapy spanning naEonal borders increasingly common.

•  Many types of vaccines are used internaEonally, with different excipients and rates of adverse reacEons.

•  Rabies is uniformly fatal disease when untreated, so post exposure prophylaxis (PEP) must be completed

•  No consensus guidelines exist for choice of rabies vaccine for administraEon aUer adverse reacEon

•  The paEent had received all childhood vaccines up to age 4 without incident, allowing some excipients to be ruled out prior to administraEon of Imovax Rabies. (See Figure 4)

•  2 possibiliEes remained as cause of reacEon: Polygeline, and the combinaEon of Beta-‐Propiolactone with Human Serum Albumin.

•  Polygeline is a bovine derived gelaEn found in Rabipur. GelaEn is the most common cause of immediate vaccine reacEons.

•  The combinaEon of Beta-‐Propiolactone and Human Serum Albumin has been found to cause a Type 3 hypersensiEvity reacEon characterized by urEcaria in 6% of paEents receiving booster doses of HDCV Rabies Vaccines, but is much rarer in primary immunizaEon sequences.

•  The paEent subsequently tolerated Imovax Rabies, decreasing the likelihood that Beta-‐Propiolactone and Human Serum Albumin caused the reacEon, and leaving polygeline as the most likely candidate (See Figure 4), although other excipients remain possible.

•  The paEent ate nothing new that day, and had no abnormal environmental exposures aUer the cat, but it remains possible that an exposure unrelated to the vaccine caused the reacEon.

Background: Untreated rabies is fatal, globally killing 60,000 persons/yr. Rabies vaccine (RV) is life-‐saving, of various types and used in high-‐risk rabies exposure (HRRE) as a post-‐exposure prophylaxis (PEP) series of iniEal (RV-‐i) and compleEon (RV-‐c) doses. Polygeline has been implicated in immediate allergic reacEons to Eck-‐borne encephaliEs vaccine and is an excipient in Rabipur, a purified chick embryo vaccine (PCECV) as part of Thai Red Cross (TRC) RV protocol. In United States (US), RVs are Rabavert (PCECV), containing polygeline, and Imovax Rabies, a human diploid cell vaccine (HDCV) that does not. RV-‐associated adverse reacEons occur up to 6% as mostly non-‐IgE/skin-‐limited or immune complex and rarely non-‐fatal anaphylaxis. We describe TRC-‐RV-‐immediate allergic reacEon in a male child traveling in Thailand and how aUer his return to US, we were able to overcome RV-‐PEP delays and demonstrate safe treatment tolerance with a different RV. Methods: Review of literature, Thai/US RV and Allergy Protocols, Pink Book/RV Inserts Results: A healthy 4-‐yr old US boy had HRRE from feral cat bite in Thailand with immediate disseminated hives at 1hr post-‐TRC-‐RVi (Day 0), resolved with oral anEhistamine. Upon US return (Days 3-‐8), clinicians stopped RV-‐PEP due to RV allergy fears; Day 6 rabies-‐immunoglobulin given. On Day 9, US academic Allergist/InfecEous Disease referral done: no other medical problems found; HDCV skin prick test (negaEve); TRC-‐RV (not available); 2-‐step HDCV-‐RV challenge performed (10%, then full); Days 13 & 20, HDCV-‐RV-‐c full tolerated; Days 30+, asymptomaEc; serum tryptase 3.2 ng/ml; Rapid Fluorescent Foci InhibiEon Test (RFFIT) ≥0.5 IU/ml Conclusion: RV type I hypersensiEvity reacEons are uncommon, components to RVs vary worldwide and such adverse RV reacEons should not stop RV-‐PEP. Analysis of vaccine content, exposures and relevant tesEng is criEcal to deducing likely reacEon type and candidate anEgens as excipients in non-‐RVs and across RV types. IgE-‐vaccine tests may not be reliable/possible and mid-‐series RV change to non-‐polygeline type may be a viable opEon when RV-‐c must be done to reach Emely RV-‐c-‐PEP treatment tolerance and avoid hypersensiEvity reacEons.

•  Regardless of severity of adverse reacEon, rabies prophylaxis must be completed.

•  In case of reacEon to Rabies vaccine, changing to a non-‐polygeline rabies vaccine and performing a 2 step graded vaccine challenge may be a viable approach.

•  Comparing excipients in already tolerated vaccines can be helpful for determining cause of reacEon and safety of administering subsequent vaccinaEons.

•  Various rabies vaccines are theoreEcally interchangeable, but there are few studies confirming this. If changing vaccines or deviaEng from the recommended CDC vaccinaEon schedule, consider confirming immune response with RFFIT.

•  It was difficult to definiEvely determine which vaccine our paEent got in Thailand. As global travel increases, exposure to diseases such as rabies and treatment across borders will become more common in US paEents. Beeer methods are needed to determine local standards of care and communicate about care received internaEonally. Methods:

Background

Results

Conclusions

Was this Anaphylaxis?

Confirming Immune Response Determining Cause of Reac0on

•  J. Michael Beckham •  MD Candidate, Class of 2018 •  Baylor College of Medicine

•  [email protected] •  325-‐660-‐7233

Verorab (PVRV) Rabipur (PCECV) Rabavert (PCECV) Imovax (HDCV)

Maltose Polygeline Polygeline MRC-‐5 Human Diploid Cells

Human Albumin Human Albumin Human Albumin Human Albumin

Sodium Chloride Amphotericin B Amphotericin B Phenolsulfonphtalein

B-‐Propiolactone B-‐Propiolactone B-‐Propiolactone B Propiolactone

Neomycin Neomycin Neomycin Neomycin

Streptomycin EDTA Sodium EDTA

Polymyxine B Ovalbumin Ovalbumin

Water for injecEon Potassium Glutamate

Potassium Glutamate

Chlortetracycline Chlortetracycline

TRIS-‐(hydroxymethyl-‐) aminomethane

Bovine Serum

Saccharose Chicken Fibroblasts

Sodium Chloride

Water for injecEon

•  Since one possible Thai Vaccines was a PCECV, and one of the US vaccine opEons (Rabavert) is also a PCECV, we thought it best to switch to Imovax Rabies (HDCV) to complete PEP (See Figure 2)

•  To be sure that the Imovax (HDCV) had a lower chance of reacEon, we compared the excipients of all 4 US and Thai vaccines. (See Figure 3, shared excipients are shaded in blue )

Changing Vaccine Type: Why We Chose Imovax Rabies •  Various rabies vaccines are theoreEcally interchangeable

for inducing immunity.

•  However, there are only scaeered case reports, and 1 study that demonstrated this by using a PCECV rabies vaccine for a booster aUer iniEal pre-‐exposure prophylaxis with an HDCV rabies vaccine.

•  The CDC/ACIP recommended rabies vaccinaEon schedule is a total of 4 doses on days 0, 3, 7, and 14.

•  Our paEent received doses on days 0, 9, 13, and 20.

•  Since our paEent switched vaccine types and had deviaEons from the recommended schedule, we confirmed anEbody response by performing RFFIT tesEng. RFFIT was ≥ 0.5 IU/ml, which is considered an acceptable response according to WHO guidelines

•  Review of literature •  Review of Thai Red Cross, WHO, and CDC/ACIP Rabies

VaccinaEon Guidelines

•  Review of AAAAI Anaphylaxis Criteria

•  Review of CDC Pink Book and Rabies Vaccine Inserts

Figure 3: Changing Vaccine Type, Why We Chose Imovax Rabies

Figure 2:

Figure 4:

The Clinical Scenario •  A 4 year old American boy was bieen by a feral cat while

visiEng his grandmother in Thailand. He received a Rabies Vaccine, thought likely to be Verorab or Rabipur based on literature review of the Thai Red Cross Protocol. He developed truncal urEcaria, but no other symptoms.

Performing a 2 Step Graded Vaccine Challenge

• Premedicated with CeErizine. Epinephrine and diphenhydramine on hand.

• Gave 0.1 ml of Imovax Rabies IM at full concentraEon (1/10th of total dose)

• Observed for 30 minutes • Gave remaining 0.9 ml Imovax IM (9/10ths of dose)

• Observed for 90 minutes.

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