hepatitis b immunization in infants of hepatitis b surface antigen-negative mothers

8/12/2019 Hepatitis B Immunization in Infants of Hepatitis B Surface Antigen-Negative Mothers

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1993;92;717PediatricsGAETANO FILICE

andMARIA CERBO, GIORGIO RONDINI, CATHERINE KLERSY, PAOLO ORSOLINIGAETANO CHIRICO, CESARE BELLONI, ANTONELLA GASPARONI, ROSA

Hepatitis B Immunization in Infants of Hepatitis B Surface Antigen-Negative Mothers

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E X P E R IE N C E A N D R E A S O N 717

tho se o f o ld er in fan ts a nd a du lts . H o w ev er, the ex -

o ge no us stim u la tion u sed in th e H an na s tu dy m a y

h a ve a ltered ad ren al funct ion an d th ereb y m ask ed

su b tle ab no rm a lit ies .4 C lea rly , th e pa tho ge ne s is o f

th e tran sien t g lu cocor tico id in su ffic ien cy ob serv ed in

som e pre m a tu re ne w bo rns rem a ins un ex p la in ed .

In co nc lu sion , w e h av e de scribe d s ix 510 - to 750 -g

n ew b orns w ho m an ifes te d hy po ten s ion th at w a s ro -

sistan t to v o lu m e exp a n ders an d v aso presso rs b u t

th a t d id resp on d to g luc oc o rtic o id the rap y . T h e

p ath op hy s io lo g ic m ec ha n ism an d fre qu en cy o f o c-

c u rre nc e o f th is d iso rd er rem a in to be e lu cida ted .

T h is w i l l requ ire care fu l ly d es ig ne d s tud ies th at p ro -

sp ec tive ly de fin e th e s ta tu s o f ad ren al fu n ction in

prematu re n ew b orn s. F u rth erm ore , con tro lled cm i-

ca l tr ia ls a re n ecessa ry to eva lu a te p ossib le com p li-

c at ion s o f th is the ra py be fo re g lu co co rtic o id s c a n be

reco m m en d ed as a stan d ard trea tm en t fo r h y p oten -

s io n in p re m a tu re ne w bo rns .

A C K N O W L E D G M E N T S

D r Insoft w a s su ppo rte d b y N ation al In stitu te of C hild H e alth

a n d H u m a n D ev e lo p m en t tra in in g g ra n t 2 T 3 2 -H D 0 7 6 1 2 .W e a re g ra te fu l to D r J o sep h K itterm a n , D ep a r tm en t o f P ed ia t-

r ica , U niv ersity o f C alifo rn ia , S an F ra nc is co , fo r h is v a lu a b le re-

vie w of th is ma n u scr ip t .

H A R O L D J. H E L B O C K , M D

R O B E R T M . Ir so v r, M D

F E U X A . C o i’m , M D

C a rd iov asc u la r R e sea rch In s titu te

D ep t o f P ed ia trics

Divisions of N eon ato log y an d E n d o cr in o lo gy

U niversity of C a lifo rn ia , S an Franc isco

R E F E R E N C E S

1. O rth D , K ouacs W , D eB old C . T h e a dr en al cor tex In : W ilson J D , F o ste r

D W, ad s. W i l li a m s T e x tb o o ko f E nd o c ri n ol o gy 8 th ed . P h ilad elp h ia , P A : W B

Sanders ; 1992

2 . K no w le s R , Sa lte r M , B ro ok s S , M oncada S . Anti- in f lammatory gluc o-

co rtic o id s in h ib it the in du ctio n by en do tox in of n itric ox id e syn thase in

the lun g , liver and ao rta of the ra t . B ic he m B io ph ys R e s C om m u n

1990;172:1042-1048

3 . W inter J SD . In : P olin R A , F ox W W , e ds. F eta l an d N eon ata l P hysio log y

Ph ilade lph ia , P A: W B S au nders ; 19922:1829-1841

4 . T h om as 5 , M u rph y JF , D y a s J, R y alls M , H u gh es I. R e spo nse to A C T H

in th e n ew bor n . A rc h D is C h ild 1986;61:57-60

5 . V e rsm old H , K itte rm a nJ, P h ib bs R , G re go ry G , T ooley W . A ort ic b loo d

pre ssu re du rin g th e firs t 1 2 ho urs of life in in fan ts w ith b ir th w eight 6 10

to 42 20 gram s. Ped ia trics 1981;67 :607-610

6. E steba n N , L o ugh lin T , Y er ge y A , et a l. D a ily co rtiso l p rod uc tion ra te in

m an d ete rm in ed by s tab le isotop e d ilu tion /m ass sp ectrom etry . I Clin

E nd oc rin ol M eta b 1991;72:39-457. D icks tein G , S hechnerC , N icho lso n W , a t a l. A dre noc ortico trop in s tim u-

la tion tes t: e ffec ts o f basa l co r tiso l leve l, t ime o f d ay , a nd s ug ge ste d ne w

sensi t ive lo w d ose te st. J C lin E n do crin o l M eta b 1991;72 :773-778

8. Shaffer 5, K ilb rid e H , H a yen L , M ea de V . W ara dy B . Hyperkalemia in

very lo w b ir th w eig ht in fa n ts. I Ped ia tr 1992;121:275-279

9 . S c o tt S . B ack kstrom S , W erne r S , H a rte nbe rge r C , W ells L . R ela t ionsh ip

of nutritiona l to leranc e to resp ira to ry co m p rom ise and co rtiso l values .

P ed ia tr R es 199231:222A

10 . S co tt 5 , W a fte rbe rg K , B lack strom C , W ern er S , W ells L C o rtiso l c o n-

cen tra t ions in th e ifi v ery low birth w eigh t in fan t. P ed ia tr R es

199231:222A

11 . H a nna C , K eith L , C ola su rd o A , et a l. H yp oth alam ic-p iim ta ry-ad ren al

funct ion in th e ex trem ely pr em atu re in fant . I C lin E n do crin o l M eta b

199326:384-387

H ep a tit is B Im m u n iza tio n in

In fa n ts o f H ep a tit is B S u rfa ce

A n tig en -N e g a tiv e M o th er s

A B B R E V IA T IO N S . A A l A m er ica n A ca d em y o f P ed ia tr ics ; H B V ,

h ep a titis B v iru s ; H B sA g , h ep a titis B su rfa ce a n tig en ; a n ti-H B s ,

an t ibody to H BsA g.

T h e A m e ric an A c a de m y of P e d ia trics (A A P ) C om -mittee on In fe c tiou s D isea ses a n d th e Im m u niz at ion

P ra ctic e s A dv iso ry C o m m itte e o f th e C en ters fo r D is-

ea se C on tro l h av e re c en tly p o in te d ou t tha t th e so -

lec tiv e s tra te gy o f im m u n iz at ion aga ins t hep atitis B

viru s (H B V ) o f h igh -r isk p op u la tio n s h as no t resu l ted

in the lim ita t ion o f the d iffu s ion o f the d isea se . In

fac t, in sp ite o f v ac c ine av ailab ility fo r m o re tha n 10

years, a b ou t 200 00 0 to 3 00 000 n ew cases of infect ion

o cc u r in th e U n ite d S ta tes e ac h y ea r. T h e refo re , th e

A A P rec om m en de d th e “ un ive rsa l he pa titis B im m u -

n iz atio n” stra te gy a s a m ea ns to c on tro l th e d is -

ease .1’2

In Ita ly , w he re a bo u t 40 0 00 0 n ew ca ses o f in fec tio n

a re e xp ec te d e a ch y ea r, the v a cc ina tio n h as b ee n ex -ten ded to a ll n ew b o rn s, rega rd less o f m other ’s sero -

lo g ic s ta tu s (a nd , fo r th e firs t 1 2 y ea rs , to a ll 12 -y e ar-

o ld ad o le sc en ts ), w ith a law p rom ulg a ted in M a y

1 9 9 1 .

F rom th at da te , w e ca rrie d o u t a s tu dy a im e d to

e va lu ate th e re spo nse to H B V v ac c ina tio n in in fa n ts

o f he pa titis B su rfac e an tig en (H B sA g) ne ga tiv e

m othe rs. M o reo ve r, w e co m p are d an a cc e lera te d

a n ti-H B V im m u niz at ion sc he du le (v ac c ine g iv en at 0 ,

1 , a nd 3 m o n th s o f life ) w ith a tra d it ion al, m o re

w id ely spa ce d sc he du le (va cc in e g iv en at 0 , 1 , an d 6

m on ths o f life ) a nd ev alu a ted the in flue n ce o f som e

fa cto rs , suc h a s sex , p re m a tu rity , o r typ e o f fee d ing ,

o n th e im m un e resp onse to v ac c ina tio n ag ain s t h e pa -tit is B in in fa n ts .

M E T H O D S

A ll h eal thy te rm and p reterm infa n ts born t o H B s A g- ne ga ti ve

m o t h e r s f rom M a y I to D ecem b er 3 1 , 1 9 9 1 , a fter a n in fo rm ed

w ritten co nsen t w a s o b ta in ed b y a t lea st o n e p a ren t, w ere in d u d ed

in th e stu dy a nd r an do m ly a l loca ted to th e a cce lera ted (g ro u p A )

o r tra d itio n a l (g ro u p B ) im m u n iza tio n sch ed u le . In g ro u p A in -

fan ts 10 pg of recom b in an t an ti-H B V vacc ine (E ng erix B , S m ith

K line & F ren ch ) w a s a d m in is tered in tra m u scu la r ly b e fo re d is-

ch a rg e f rom th e h o sp ita l, a t I m o n th a n d a t 3 m o n th s o f life , w h ile

in gro up B in fan ts th e sa m e dose o f v a cc in e w as a d m in istered

b e fo re d isch a rg e, a t I m o n th a n d a t 6 m o n th s o f life .

In fan ts w ith in fec tio n , m a lfo rm a tio n , o r sev ere illn e s s w ere ex -

c lu d ed f rom th e s tu dy .

T h e fo llo w in g d a ta w ere recorded fo r ea ch in fa n t: sex , g es ta -tio n a l a g e , birth weigh t , an d m aternal m ilk or fo rm ula fe ed ing .

In all in fan ts a sa m p le o f 1 .5 m L o f b lo o d w a s o b ta in ed fo r

m ea su rem en t o f serum a n ti-H B sA g a n tib o d y (a n ti-H B s) co n cen -

tra tio n b e fo re th e a d m in istra tio n o f th e fir st do se o f v a cc in e a n d I

m o n th a fter th e la s t d o se, ie , a t 4 m o n th s o f a g e in g ro u p A in fan ts

a n d a t 7 m o n th s in g ro u p B in fan ts.

S eru m con cen tra tion of an ti-H B s w a s eva lua ted by e nzy m e -

l inked im m u n o so rb en t a ssa y u s in g th e a n ti-H B s (M B S , I ta ly ) co m -

R eceiv ed for pub lic atio n Feb 8 , 1 9 9 3 ; accep ted A pr 30 , 1993 .

R eprin t re qu ests to (G .C .) D ivis ion e d i P a tolo gia N eon ata le, P o lic lin ico Sa n

Matteo , 27100 Pa v ia , I ta ly .

P E D IA T R K S (IS S N 0 031 400 5). C op yr igh t © 19 93 b y th e A mer ica n A ced -

em y o f Pediatr ics.








71 8 E X P E R IE N C E A N D R E A S O N

mercial kit; te s ts w ere a u to m a tica lly p erfo rm ed b y th e B eh r in g

E LIS A P ro ces sor II instrum ent . L ow er a n d h ig h er sen sitiv ity lim it s

o f th e assay w e re 2 a n d 10 0 m IU /m L, respec tiv e ly .

A n in fan t w as con side red a nonrespon der if the an ti-H B s serum

lev e l w a s u n d e tecta b le , a lo w resp o n d er if a n ti-H B s w a s le ss than

1 0 m IU /m L , a n d a h ig h resp o n d er w h en serum a n ti-H Bs co n cen -

tra tio n w a s 1 00 m IU /m L .

S ta t is tica l a n a ly s is w a s ca rr ied o u t b y m ea n s o f F ish er ’s E x a ct

T es t o r 2 te st w ith Y a te s ’ co rrec tio n fo r continu i ty to e va lu ate

diffe ren ces b etw een gro up s. L o gis tic reg res sio n m o de ling w as

used to id en tify po ss ib le p rognos tic fac to rs fo r b eing a h igh re -

sp o n d er . W ith th is m ultivar ia te te chn iqu e th e in d ep en d en t v a lu e

o f sev era l fa c to r s , co n s id ered to g e th er , ca n b e a sse ssed in rela t io n

to a b in a ry response v ariab le (h igh o r n o n -h ig h resp o n d er ). A c -

cord ing to A itk in e t a l,3 m a rg in a l a n d cond i t iona l te s t s w ere p er-

fo rm ed in o rd er to se lec t th e b est p red ic to r fo r th e m o d e l. T h e

se lec t ion o f v a r ia b le s to b e in c lu d ed in th e m o d e l w a s b a sed o n

cl in ical c on sid era tion s; th e fo llo w in g cov ariate s w ere con sid ere d:

va ccinat ion sche dule , sex , g e sta tio n a l a g e , bir th w eig h t, a n d ty p e

o f feed in g . T h e G lim 3 sta tist ical p ack age w as u sed .

R E S U L T S

T h e re su lts o f a n ti-H B s e va lu a tion w er e ava ila b le

in 4 08 in fan ts ; o f th ese ne w b orn s , 2 08 w e re m ale an d

20 0 fe m a le, 3 71 w e re te rm (g esta tion a l ag e fro m 3 8 to

43 w e e ks) an d 37 p reterm (g es ta tio na l a ge from 27 to

37 w eek s), 13 5 w ere fed m o th er ’s m ilk a nd 2 73 ro-

ce iv ed a m ilk fo rm u la ; 18 3 infants w e r e in c lu d ed in

group A a n d 22 5 in gr ou p B .

In a ll in fan ts o f b o th g rou ps , an ti-H B s w a s u nd o-

tec ta b le a t b irth , b efo re th e im m un iza tio n .

A n ti-H B s co nc en tra tion s m e a su red I m o n th a fter

co m p letio n o f th e immun iz a t ion sc h e d u le a re re -

ported in T a b le 1 . In 1 00 (5 4 .6 % ) grou p A a nd in 1 96

(87 .1 % ) grou p B in fa n ts, seru m an ti-H B s a ntib od y

co nc e n tra tio n w a s 1 00 m IU /m L P < .000 1 by the

x2 sq u a re te st).

T h er e w er e on ly tw o n on re sp on d e r in fan ts w ith

un de te cta b le le v els o f a n t i-H B s, bo th in g ro up B .

A n ti-H B s c on c en tra t ion be lo w 1 0 m IU /m L w a s ob -

ser ve d in 4 g ro u p A an d in 4 g ro u p B in fa n ts; th e re -

for e , th e gr e at m ajo rity (97 .8% o f gr ou p A an d 9 8 .2%

of g roup B ) o f th e in fan ts stu d ied d e ve lop ed a p ro -

te c tive lev el o f an tib od y (1 0 m IU /m L ).

In in fa n ts o f b oth g ro u p s n o sig n ific a n t d iffer e n c es

in im m un e re sp on se w e re rec o rd ed in re la t ion to sex ,

b irth w eigh t, o r m e th od o f fe ed in g .

A s see n in T ab le 2 , a ll th e p rete rm in fa n ts de ve l-

o_ a p r ote ctive lev el o f a n ti-H B s (10 m IU /m L );

21 (56 .7 % ) of th em w e re h igh re spo nd ers .

Log ist ic re g re ss ion a na ly s is co n firm e d th e s ig nifi-

ca n t in flu e n ce of th e v ac c in a tion sc h e d u le on an ti-

b o d y r esp o n se : in fan ts w h o re c eiv ed th e m o re w id e ly

sp ac e d va c cin a tion sch ed u le ha d a risk (od ds ra tio )

o f be in g h igh re spo nd ers 5 .78 tim es (95 % c on fide nc e

in te r va l 5 .29 to 6 .27 ) th a t o f th e in fan ts w h o r ec eive d

th e a c ce le ra ted im m u n iza tion sc h e d u le . M o r eo ve r, a

T A B L E 2. Serum C on cen tration o f Antibody to H ep a titis B

S urface A n tige n (m IU /m L ) in Te rm an d P reterm In fan ts A fter

Vaccinat ion*

Gestat ional A g e , w k N o . o f S u b jec ts G M C R a n g e

27-33 6 3 .4 13-100

34-37 23 7 0 .2 10-100

38-42 371 73 .5 < 2-10 0

R esults are exp res sed a s g eo m etr ic m ea n co n cen tra t io n (G M C ).

sign if ican t in flu en c e o f g esta tion a l ag e w as ob se rv e d :

th e risk (od ds ra tio ) o f be in g a h ig h re sp on de r w a s

1 .16 7 tim es (95 % c o nfid en ce in terv al 1 .03 to 1 .3 )

h ig h e r for e ac h in cr e ase o f 1 w ee k of g e sta tion a l age .

L og istic reg re ssion a n alys is d id n ot sh ow sign ifica n t

d iffe ren ces fo r the o the r cov aria tes cons ide red : b irth

w eigh t, sex , an d ty p e o f fee d in g .

N o sign ifica n t s id e e ffec ts w ere re c o rd ed a fte r v ac -

cine adm ini s tr a t ion .

D I S C U S S I O N

D a t a from th e p r e se n t stu d y c on fir m th e ve ry go od

neonatal response to H BV im muniza tion ; in fa ct, a

pro tect ive lev el o f an ti-H B s (10 m IU /m L ) w as ob -

served in 98 % of infants , w hile o n ly 0 .5 % of the in -

fa n ts w ere no nre spo nde rs . T he se re su lts are in a g re e -

m e n t w ith p r ev iou s stu d ies w h ic h re p o rte d th a t

m o re th an 95 % of infants b o rn to H BsA g -p o sitive

m o th e rs d e ve lop ed a satisfa cto ry im m u n e re sp o n se.1

M c M a h o n et a 14 r ep or ted th a t th e v ac c in a tion o f a ll

suscep tib le su b jec ts , in duc tin g infants of H B sA g -

n e ga tive m o th e rs , resu l ted in th e r ed u c tion of th e

in c id en c e of H B V in fe c tion in A lask an n a tiv es ; h o w -

e ve r, in th at stu d y , n o d ata h av e b ee n re p o rte d o n

d e ve lo p m e n t of im m u n e r esp on se in in fa n ts .

B o oy e t a l5 fou n d low er a n tib o d y c on ce n tr atio n

against d ip h th er ia an d te tan u s afte r a n ac c ele r ate d

n ew im m un iz atio n sch ed u le (v ac c in e g iv en at 2 , 3 ,

an d 4 m on th s o f l ife), as c om p ar e d to th e o ld , m or e

w id e ly sp ac ed r eg im e n (v ac c in e g iv en at 3 , 5 , a n d 9

m o nths o f life) . T h is d iffe rence w as th oug h t to be due

e ith e r to th e in h ib ito ry e ffe ct o f m a ter n a l sp e cific

an tibo dy transferred to th e fetu s th r ou g h th e p la -

c en ta , o r to th e r ela tive immatu ri ty of th e im m u n e

syste m in sm aller in fan ts. In ac co rd an c e w ith B o o y

an d c o w ork er s’ f ind ing afte r im m u n iza tion ag a in st

d ip h th e r ia a n d te tan u s , w e ob se rv e d th a t a n a cc e ler -

a te d h ep atitis B v ac cin atio n sch ed u le ca n r esu lt in

pro tect ive con cen tratio n o f an tib od ies ag a in st H B V ;

h o w ev er , th e re s pons e w as red uced w h en co m p ar ed

w ith th e re sp on se to th e tr ad ition a l, m or e w id ely

sp aced s c he du le . S in c e n o n e o f th e infants evaluated

h a d d e tec tab le p re im mu n iz atio n s e rum c onc e ntr a-

tio n o f an ti-H B s, w e ca n ex d u d e th e in ter fe re n c e b y

T A B L E 1 . S erum C on cen tra tion of A n t i b o d

c ina t ion in th e T w o G ro u p s o f In fa n ts S tu d ied

y to H ep a titis B S u r fa ce A n tig en I M o n th A fter V a c -

Vaccinat ion S ch ed u le

0 , 1 , 3 m o , N o . (% ) 0 , 1 , 6 m o , N o . (% )

U ndetecta b le (n on resp on der )

< 1 0 m IU /m L (lo w resp o n d er)

1 0 m IU /m L (resp o n d er )

1 00 m IU /m L (h igh respon der)

2 (0 .9 )

4 (2 .2 ) 4 (1 .8 )

7 9 (4 3 .2 ) 2 3 (1 0 .2 )

1 00 (5 4.6 ) 1 9 6 (8 7 .1 )

G eometr ic m e an c on ce nt ra ti on 60 .4 m IU /m L 8 5.0 m IU /m L









E X P E R IE N C E A N D R E A SO N 719

m a ter n a l sp ec ific an tib od ies; w e c an sp ec u la te th at

th e re d u ce d re sp on se a fter th e ac ce le ra ted sch ed u le

w a s m ain ly d ue to th e re la tive immatur i ty of the

i m m u n e sy stem in y ou ng er in fa n ts .

D e M ar tin o e t a l6 re p o rte d a tr an sie n t, s ligh t ro -

d u c tio n o f sp e cific a n tib od y p r od u ction afte r va cc i-

n a tion ag a in st h e p a titis B in m ate rn a l m ilk -fe d in -

fan ts , co m p are d w ith fo rm u la-fe d in fa n ts. T h is

red uc tio n w a s a ttr ib u te d to th e inh ib ito ry effe ct o f

an ti-H B s an tibo dy in m a tern al m ilk . W e fo und n o

in f luence o f the m e tho d of feed ing on resp on se to the

vacc ine . H o w e v er , th e m o th er s in o u r stu d y w er e

H B sA b -n eg ativ e ; the re fo re, ou r fin d ing s, a ltho ugh

in d ire ct ly , se e m to c on firm D e M a rtin o a nd co l-

leag ues’ hyp o thesis .

In th e p r e ter m in fan ts in clu d e d in ou r stu d y , w e

ob se rv ed a n ad eq ua te im m un e resp on se , a lth oug h it

w as s ligh tly re du ce d co m pa red w ith the re sp on se o f

term in fa n ts; th e refo re , ou r fin d ing s sup po rt th e rec -

om m en da tion o f th e A A P tha t p rem a tu re in fan ts

sh ou ld r e ce ive h e p atitis B va cc in e at th e sa m e

ch ron o log ic ag e as term in fan ts.2

L au e t a l,7 a t v ar ian ce w ith ou r r esu lts , re p o rte d a

low se r op o sitiv ity r ate (7 9% ) in a gr ou p of p re d o m i-

na n tly C h ine se pr e te r m in fa n ts w ith b irth w e igh t o f

less tha n 1 75 0 g w h o re ce iv ed the va c cin e a t b irth , a t

1 m o n th , an d at ap p ro x im ate ly 5 m on th s o f life . T h e

seropos i t ivi ty r ate w a s b e tte r (91 % ) if th e ad m in is-

tra tion o f th e fir st d ose of v ac c in e w as d ela ye d un t i l

the in fa n ts w e igh ed m ore tha n 200 0 g . T h e h igh in -

c id e nc e o f n on resp on de rs in L au an d c ow ork e rs ’

s tud y co u ld b e due eithe r to a g en e tic p red ispo si tion

to h y p or e sp on sive n e ss to H B V va cc in e in th e e th n ic

group ev a lu ate d , o r to th e e xtr em e p r e m a tu rity of th e

infants .

In c on clu s ion , im m u n iz atio n a ga in st h e p atitis B

w a s a s e ffec tiv e in in fan ts o f n on c a m e r m o th er s a s in

in fa n ts b o rn to H B 5 A g -po s itiv e m o the rs .T h e a d m in istr a tio n of an ac ce le ra ted i m m u n i z a -

tion sc h e d u le c an b e u sed in p atie n ts a t ve r y h igh risk

o f d ev elo p ing he pa tit is B in fe ction , suc h a s in fan ts

bo rn to ca rrie r m o th ers o r w ith h ou se ho ld c on tac ts o f

H B V ca r rie r s. H ow ev er , in p atie n ts a t low risk , th e

tra d itio n a l, m or e w id ely sp ac e d im m u n iz atio n

sch e d u le is to b e p r efe r re d b e c au se o f th e b e tter re -

spon se w ith h ig he r se rum co nc en tra tion o f a n ti-H B s

an t ibod ies .

A C K N O W L E D G M E N T

W e a re v ery thankfu l to nu rse A nn a D a l C in fo r h elp w ith b lo o d

sa mp l in g .

G o C iuuco , M D *

C ss au B E L L O N I , M D*

A N T O N E L L A G P oM , M D *

R O S A M AR IA C iaso , M D *

G Io R cIo R o r i, M D *

C A TH ER IN E K L E R 5Y , M D I :

P AO LO O RS OL IN I, M D

G o F iuc M D

D ivisio n o f N eon ato log y an d N e ona tal In tens ive C a re

S cie n tif ic D ire ct ion

§ Ins titu te o f In fec tious D iseases

P o lid in ico San M afteo I R C C S

Pav ia , Ita ly

R E F E R E N C E S

1 . A m e ric an A cad em y of P ed iatrics , C om miftee on In fect iou s D ise ase s.

Unive r sa l he pat itis B immuniz a t ion . Ped ia trics 199289:795-800

2 . H all C B , H a lsey N A . C on tro lof h epa titis B : to be o r n o t to be? Ped ia trics

199290:274-277

3 . A itk in M , A n de rson D , F ra ncis B , H in deJ . S ta tis tic a l M ode llin g in G UM

Oxford , E n gl an d: C la re nd on Press ; 1989

4. M cM ah on B J, R hoades E R , H ey w a rd W L , e t aL A com prehensive pro -

g r a m m e to reduce th e in cidence o f h ep a titis B v irus in fe ctio n its s e-

quelae in A l a sk a n na t ives . Lancet 1987330:1134-1136

5 . B ooy R , A itk en S JM , T a ylo r 5, et aL Immunogenici ty o f co m bin ed d ip h -

the ria, te tan us an d pertussis vacc in e g iven a t 2, 3 an d 4 m onths ver sus

3 , 5 a nd 9 m onths of a ge. Lancet 1992339:507-510

6 . D e M a rtin o M , R es ti M , A pp en din o C , V ierucc i A . D iffere n t deg ree of

an tibody response to h ep atitis B v irus vacc ine in b rea st-fed a nd for -

m ula -fe d in fan ts born t o H B s A g - p o s it i v e mothers. I P ed ia tr G a st ro en te m l

Nu b 19876:208-211

7 . L an Y , T am A Y C , N g K W , a t a L R esp ons e of pre te rm in fan ts to hepat i t is

B vaccine. I Ped ia tr 1992;121:%2-965

A E ute ctic Mixtu re o f L id oca in e

a n d P r ilo c a in e fo r A llev ia tin g

V a cc in a tio n P a in in In fa n ts

A B B R E V IA T IO N . E M L A , eu tectic m ix tu re o f lo ca l a ne sth etic s.

T h e d isco m fo rt a n d p a in ca use d b y va cc in ation

m a y p rev en t som e paren ts fro m h av in g th eir yo u n g

ch ild re n v ac c ina te d . Im m un iza tio n u p tak e is go od

am o n g sc h o o l-a ge c h ild r en , b u t u p ta k e r a tes a ve ra ge

only a bou t 70 % in yo un ge r c h ild ren a nd fig u re s as

low a s 2 5% h a ve be e n re po rte d a t 19 m on ths .5 Y e t it

w o u ld be im po rta n t to a ch ie ve a s h igh a n im m un i-

zat ion u p ta k e as p o ssib le , s in c e if th e va cc in a tion

co ve ra ge is good en ou g h , ev e n n o n va cc in ate d m d i-

v idua ls w ill b e p r ote c ted b y th e h e r d im m u n ity th at

h inders th e oc cu rr e n ce o f e p id e m ics .P a in fu l p ro ce du res are frigh te n in g , e spe cia lly in

in fa nc y , w h e n c h ild re n do no t u nd ers ta nd w ha t is

happen ing to th em . V ac cin atio n -a sso cia ted p a in m ay

affe ct in th e sh o rt-te rm b oth th e p h y sica l a n d m en ta l

w e ll-b ein g o f c h ild re n an d th e ir fa m ilies , a s w e ll as

th eir ov er a ll ap p ro ac h to m e d ic a l ca r e. A e u te c tic

mix tu re of lo ca l a ne s th etic s (E M L A ) c on ta in in g p ri-

loc aine 2 5 g /L a nd lid oc ain e 25 g /L in a n o ily b ase

ha s re ce n tly be c om e av ailab le fo r top ica l a ne s the s ia6 ;

it is a lso re g is te red in the U n ite d S ta tes a nd h as b ee n

sh ow n to b e e ffe ctive in re liev ing pa in a ris ing fro m

ve n ou s ca n n u la tion a n d m in or su r g ic a l p r oc o-

dure s P11 T h e p o ss ib ility o f u s in g this p rep a ra tio n to

re lie ve th e pa in assoc ia ted w ith vaccin atio n in infantsw a s e va lu a ted in a r an d om ize d , d o u b le-b lin d tr ia l in

connect ion w ith a n or m a l va cc in a tion p r og ra m .

M E T H O D S

A ll p a ren ts br ing ing their in fan ts to clin ic s in th e to w n o f O u l u

from February 1991 to June 1992 fo r th e n o rm al v a cc in a tio n pro-

g ram w ere offe red th e o p p o r tu n ity to p a r ticip a te in th e su rv ey .

Received fo r pub lica tion N ov 23 , 1 99 2; a cc ep te d A pr 2 8 , 1993 .

R ep rin t re qu es ts t o ( M U. ) D e p t of P ed iatr ics , U n ive rsi ty ofO ulu , F IN -90 22 0

O u l u , Fin land .

P E D IA T R K 3 (IS S N 0 03 1 400 5). C o py righ t © 19 93 b y th e A merican Ac e d-

em y of Pediatr ics.








1993;92;717Pediatrics

GAETANO FILICEandMARIA CERBO, GIORGIO RONDINI, CATHERINE KLERSY, PAOLO ORSOLINI

GAETANO CHIRICO, CESARE BELLONI, ANTONELLA GASPARONI, ROSAHepatitis B Immunization in Infants of Hepatitis B Surface Antigen-Negative Mothers

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hepatitis b immunization in infants of hepatitis b surface antigen-negative mothers

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