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Chin‐Yun Lee, Li-Min Huang, Mei‐Hwei Chang, Ching-Ying Hsu, SHOU-JON Wu, JUEI-LO Sung, A. Safary (1991)
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Abstract • Objective. —To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth. Design. —Randomized study of infants born to mothers positive for hepatitis B surface antigen (HBsAg) and hepatitis Be antigen (HBeAg). Setting. —Three large city hospitals and one rural area providing prenatal care and obstetric services. Subjects. —Eighty neonates of HBsAg- and HBeAg-positive carrier mothers received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine (10 μg) at 0,1, 2, and 11 months of age (group A) or at 3, 4, 5, and 11 months of age concomitant with diphtheria, pertussis, tetanus, and polio immunization (group B). A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months. Main Outcome Measures. —Blood samples were collected at 0,3,6,11, and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg. Follow-up visits were scheduled annually up to 5 years of age. Results. —Eight infants were excluded from analysis. During the study period, six children became HBsAg carriers, three in each group, which corresponds to a 5-year incidence of infection of 9% and 8% for groups A (three of 35) and B (three of 37), respectively. Subclinical infections (persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc) were encountered in another eight infants (four in each group). Conclusion. —Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age.(AJDC. 1993;147:1316-1320) References 1. Mazel JA, Schalm SW, De Gast GC, et al. Passive-active immunization of neonates of HBsAg-positive carrier mothers: preliminary observations . BMJ . 1984;288:513-515.Crossref 2. Schalm SW, Mazel JA, De Gast GC, et al. Prevention of hepatitis B infection in newborns through mass screening and delayed vaccination of all infants of mothers with hepatitis B surface antigen . Pediatrics . 1989;83:1041-1047. 3. Beasley RP, Hwang LY, Lin CC, et al. Hepatitis B immune globulin (HBIG) efficacy in the interruption of perinatal transmission of hepatitis B virus carrier state . Lancet . 1981;2:388-393.Crossref 4. Szmuness W, Stevens CE, Harley EJ, et al. Hepatitis B vaccine in medical staff of hemodialysis units: efficacy and subtype cross-protection . N Engl J Med . 1982;307:1481-1486.Crossref 5. Goudeau A, Yvonnet B, Lesage G, et al. Lack of anti-HBc IgM in neonates with HBsAg carrier mothers argues against transplacental transmission of hepatitis B virus infection . Lancet . 1983;2:1103-1104.Crossref 6. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient . Br J Cancer . 1976;34:585-612.Crossref 7. Lenter C, ed. Geigy Scientific Tables . 8th ed. Basel, Switzerland: Geigy; 1982:89-102. 8. Wong VCW, Ip HMH, Reesink HW, et al. Prevention of the HBsAg carrier status in newborn infants in mothers who are chronic carriers of HBsAg and HBeAg by administration of hepatitis B vaccine and hepatitis B immune globulin: double-blind randomized placebo-controlled study . Lancet . 1984; 1:921-926.Crossref 9. Beasley RP, Hwang LY, Stevens CE, et al. Efficacy of hepatitis B immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: final report of a randomized double-blind, placebo-controlled trial . Hepatology . 1983;3:135-141.Crossref 10. Beasley RP, Hwang LY, Lee GCY, et al. Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine . Lancet . 1983;2:1099-1102.Crossref 11. Stevens CE, Taylor PE, Tong MJ, et al. Yeast-recombinant hepatitis B vaccine: efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission . JAMA . 1987;257:2612-2616.Crossref 12. Poovorawan Y, Sanpavat S, Pongpuniert W, Chumdermpadetsuk S, Sentrakul P, Safary A. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers . JAMA . 1989;261: 3278-3281.Crossref 13. Lee CY, Huang LM, Chang MH, et al. The protective efficacy of recombinant hepatitis B vaccine in newborn infants of hepatitis Be antigen-positive-hepatitis B surface antigen carrier mothers . Pediatr Infect Dis J . 1991;10:299-303.Crossref 14. Ip HMH, Lelie PN, Wong VCW, Mimms L, Reesink HW. Prevention of the HBV-carrier state in infants of HBsAg- and HBeAg-positive mothers with high and low serum levels of HBV-DNA: a 3-year placebo-controlled study comparing the efficacy of hepatitis B vaccine with and without hepatitis B immunoglobulin . Lancet . 1989;1:406-410.Crossref 15. Carman WF, Zanetti AR, Karayannis P, et al. Vaccine-induced escape mutants of hepatitis B virus . Lancet . 1990;336:325-329.Crossref 16. Da Villa G, Piazza RI, Picciotto L, et al. A pilot model of vaccination against hepatitis B virus suitable for mass vaccination campaigns in hyperendemic areas . J Med Virol . 1992;36:274-278.Crossref 17. Stroffolini T, Pasquini P, and collaborating group. Five years of vaccination campaign against hepatitis B in Italy in infants of hepatitis B surface antigen carrier mothers . Ital J Gastroenterol . 1990;22:195-197. 18. Inskip HM, Hall AJ, Chotard J, Loik F, Whittle H. Hepatitis B vaccine in the Cambian expanded programme on immunization: factors influencing antibody response . Int J Epidemiol . 1991;20:764-769.Crossref 19. Prevention of perinatally transmitted hepatitis B infection . Lancet . 1984;1:939-941. Editorial.
American Journal of Diseases of Children – American Medical Association
Published: Dec 1, 1993
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