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Controlled Trial of Immune Response of Preterm Infants to Recombinant Hepatitis B and Inactivated Poliovirus Vaccines Administered Simultaneously Shortly After Birth

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Controlled Trial of Immune Response of Preterm Infants to Recombinant Hepatitis B and Inactivated Poliovirus Vaccines Administered Simultaneously Shortly After Birth F24 2000;83:F24–F27 Arch Dis Child Fetal Neonatal Ed Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/fn.83.1.F24 on 1 July 2000. Downloaded from Controlled trial of immune response of preterm infants to recombinant hepatitis B and inactivated poliovirus vaccines administered simultaneously shortly after birth Nehama Linder, Rachel Handsher, Boris German, Lea Sirota, Mike Bachman, Sigal Zinger, Ella Mendelson, Asher Barzilai Abstract Keywords: preterm infants; hepatitis B; poliovirus; vac- Aim—The study was conducted to evalu- cination; antibody ate the immunogenicity of an early, extra dose of enhanced inactivated poliovirus During the summer of 1988, an outbreak of vaccine (IPV) administered simultane- poliovirus type 1 occurred in Israel. One of the ously with recombinant hepatitis B vac- victims was a 2 month old baby who had not cine (HBV) to preterm infants shortly yet been immunised.1 Two studies performed after birth. since then have shown that approximately 50% Methods—Three groups were studied. of preterm infants lack positive titres ( 1:8) to Fifty preterm infants received IPV intra- > at least one of the poliovirus types, and may muscularly within 24 hours of birth, in benefit from early vaccination with inactivated addition to routine recommended child- polio vaccine (IPV).23 hood immunisations. Fifty two preterm In 1992 hepatitis B vaccine (HBV) was infants and 35 full term infants received introduced in Israel for vaccination of all new- routine immunisations only (routine vac- borns, including preterm infants, soon after cination timing: HBV at birth, 1 and 6 birth. Concomitant administration of HBV months of age; IPV at 2 and 4 months; oral and IPV has been shown to be eVective in full polio vaccine (OPV) at 4 and 6 months; term infants,4 but there are no studies in diphtheria-tetanus-pertussis (DTP) at 2, preterm infants. 4, and 6 months; and Haemophilus influ- This study aimed to evaluate the immuno- enzae B vaccine at 2 and 4 months). Blood genicity of IPV and HBV administered simul- samples were taken at birth, 3 and 7 taneously to premature infants within the first months of age from all infants, and at 1 24 hours of life. month of age from preterm infants only. Results—At birth, a lower percentage of both study and control preterm infants Materials and methods Department of had antipoliovirus type 3 titres > 1:8 than SUBJECTS Neonatology, The study population included 177 infants: http://fn.bmj.com/ Schneider Children’s full term infants. At 1 and 3 months of age Medical Center of significantly more early IPV infants had 127 preterm infants and 50 full term infants. Israel, 14 Kaplan St, antipoliovirus type 3 titres > 1:8 than rou- Preterm infants were born between June and Petah Tikva 49202, December 1994 (gestational age 30–35 weeks, Israel tinely vaccinated preterm infants N Linder (p < 0.05). At 7 months of age there were weight > 1000 g). Fifty healthy full term B German no significant diVerences in percentage of infants (gestational age > 37 weeks, weight L Sirota > 2500 g), born consecutively in the morning M Bachman antipoliovirus titres > 1:8 or geometric mean times (GMTs) between the early IPV hours between 1 June 1994 and 15 June 1994 on September 30, 2021 by guest. Protected copyright. Department of group and the routinely vaccinated pre- were recruited as controls. Forty children were Neonatology, The term group. At 3 and 7 months of age, the excluded: 22 preterm infants who received Chaim Sheba Medical blood products, three preterm infants with Center, Tel Hashomer, percentage of positive antihepatitis B and Sackler School of titres (> 1:10) and the GMT of the early sepsis, and 15 full term infants who were with- Medicine, Tel Aviv IPV preterm group did not diVer signifi- drawn by their parents after the first blood test. University, Tel Aviv, The preterm infants were divided into a Israel cantly from those of preterm controls. S Zinger There was no significant diVerence in per- study group (group A; n = 50) and a control centage of positive antihepatitis B titres group (group B; n = 52) by 1:1 randomisation The Central Virology between the early IPV group and full term using a blinded envelope drawn by the parents. Laboratory, The All full term infants were included in control Chaim Sheba Medical controls at any time. GMTs for hepatitis B Center antibodies were significantly lower in the group C. R Handsher early IPV preterm group than in full term The study protocol was approved by the E Mendelson controls at 3 and 7 months of age. hospital human ethics committee and in- Pediatric Infectious Conclusions—Administration of an addi- formed parental consent was obtained for all Diseases, The Chaim tional dose of IPV simultaneously with subjects. Sheba Medical Center routine HBV to preterm infants shortly Infants in the study group A received an A Barzilai after birth provides early protection from extra, early dose of IPV within 24 hours of Correspondence to: poliovirus and hepatitis B infection, and birth, simultaneously with the routine HBV, Dr Linder followed by all routine vaccinations at the email: [email protected] does not interfere with poliovirus antibody production at the age of 7 months. appropriate times (table 1). The early IPV was Accepted 11 November 1999 (Arch Dis Child Fetal Neonatal Ed 2000;83:F24–F27) administered to one thigh and the HBV to the F25 Preterm immune response to vaccines Arch Dis Child Fetal Neonatal Ed: first published as 10.1136/fn.83.1.F24 on 1 July 2000. Downloaded from Table 1 Vaccination protocol: first six months of life portion of infants in each group with detectable antibodies to poliovirus types 1, 2, and 3 was Vaccination Birth One month Two months Four months Six months compared for each type of antibody using the IPV X* X X Pearson ÷2 test. Seroconversion was defined as OPV X X the appearance of neutralising antibodies in HBV X X X DTP X X X seronegative infants or a fourfold or greater HiB X X increase over the titre expected following the decay of transplacentally acquired antibodies. *Only study group A received IPV at birth. IPV, enhanced inactivated poliovirus vaccine, one ampoule intramuscularly (RIVM, Bilthoven, The expected titre was calculated using an Holland); OPV, oral poliovirus vaccine, two drops by mouth (SmithKline Beecham, Rixemsart, antibody half life of 28 days.89The proportion Belgium); HBV, hepatitis B vaccine, 0.5 ml (10 µg/0.5 ml) intramuscularly (Engerix; SmithKline Beecham, Belgium); DTP, diphtheria-tetanus-pertussis vaccine, 0.5 ml intramuscularly (Pasteur of infants seroconverting was compared for Merieux, Lyon, France); HiB, Haemophilus influenzae B vaccine intramuscularly (H-B-VAX; each type of antibody using the Pearson ÷2 test. Merck, Sharp and Dohme, West Point, USA). The geometric mean titres (GMTs) for Table 2 Clinical characteristics antipolio were derived from the mean values after log2 transformations. Titres < 1:8 were Preterm study Preterm control Full term control calculated as 1:4, whereas titres > 1:8192 were group (A) group (B) group (C) (n = 50) (n = 52) (n = 35) calculated as 1:16 384. The GMTs for anti- hepatitis B were calculated from the log of the Male/female 23/27 22/30 17/18 10 Median (range) gestational age (weeks) 32 (30–35) 32 (30–35) 40 (38–42) titres. Titres < 1:10 were calculated as 1:5, Mean (SD) birth weight (g) 1528 (384) 1597 (402) 2990 (676) while titres > 1:1000 were calculated as 1:2000. To determine the significance of the diVer- other thigh. Preterm infants in group B and full ences in antibody levels, we applied analysis of term group C received only routine immunisa- variance to the log values (antipolio titres) and tions (table 1). 2 the log10 values (antihepatitis B titres) of the Blood samples for the determination of anti- reciprocal antibody titres with Bonferroni’s body titres were obtained from all infants correction for multiple comparisons. All statis- within the first 24 hours of life and at 3 and 7 tical tests were two sided with a significance months of age, and additionally from infants in level of p < 0.05. groups A and B at 1 month of age. SEROLOGY Results Sera were kept frozen at −20°C until tested Patient characteristics are presented in table 2. using a microneutralisation system for the Groups A and B were similar for sex distribu- three poliovirus antibody serotypes.5 Serial tion, median gestational age, and mean birth twofold dilutions of sera were prepared and weight. No local or systemic side eVects to divided into aliquots in duplicate into 96-well either vaccine were noted. microtitre plates; 32–100 TCID50 of poliovirus were added to each well. The mixtures were POLIO incubated at 36°C for 20 hours, and then The percentage of infants with antibody titres 20 000 Hep-2 cells were added to each well. > 1:8 and the GMTs for poliovirus types 1, 2, The plates were incubated at 36°C for four and 3 are shown in tables 3 and 4. days. On the fifth day, cells were fixed, stained, At birth, a lower percentage of preterm http://fn.bmj.com/ and examined macroscopically for cytopathic infants (from both preterm groups) than full eVects. term infants had antipoliovirus type 3 antibody Titres were determined as the highest dilution titres > 1:8 (p < 0.05). A significantly higher of serum protecting 50% of the cultures against number of early IPV group A premature infants had antipoliovirus type 3 titres > 1:8 32–100 TCID50 of challenge virus. Titres > 1:8 were considered seropositive.6 than routinely vaccinated premature controls Hepatitis B surface antibodies (HBsAB) (group B) at 1 and 3 months (p <0.05).
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