Protective efficacy of hepatitis B vaccine without HBIG in infants of HBeAg-positive carrier mothers in Thailand

The primary objective of this study was to estimate the efficacy of a recombinant hepatitis B vaccine (H-B-VAX™II) in preventing chronic hepatitis B infection when given alone without concomitant hepatitis B immune globulin (HBIG) to healthy Thai infants born of HBeAg-positive carrier mothers. The i...

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Bibliographic Details
Published in:	Vaccine Vol. 20; no. 31; pp. 3739 - 3743
Main Authors:	Lolekha, Somsak, Warachit, Boonyarat, Hirunyachote, Amporn, Bowonkiratikachorn, Piyaporn, West, David J, Poerschke, Gabriele
Format:	Journal Article
Language:	English
Published:	Oxford Elsevier Ltd 01-11-2002 Elsevier
Subjects:	Apgar Score Biological and medical sciences Carrier State - immunology Carrier State - therapy Carrier State - virology Female Fundamental and applied biological sciences. Psychology Hepatitis B - blood Hepatitis B - prevention & control Hepatitis B - transmission Hepatitis B e Antigens - blood Hepatitis B Surface Antigens - blood Hepatitis B vaccine Hepatitis B Vaccines - adverse effects Hepatitis B Vaccines - immunology Hepatitis B Vaccines - therapeutic use Hepatitis B virus Hepatitis B virus - immunology Hepatitis B virus - isolation & purification Humans Immunization Programs Immunization Schedule Immunization, Passive Immunoglobulins - therapeutic use Infant, Newborn Infectious Disease Transmission, Vertical - prevention & control Male Microbiology Perinatal hepatitis B infection Protective efficacy Treatment Outcome Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies Vaccines, Synthetic - adverse effects Vaccines, Synthetic - immunology Vaccines, Synthetic - therapeutic use Virology Thailand Asia Protective efficacy Hepatitis B vaccine Perinatal hepatitis B infection Human Seropositivity Treatment efficiency Vaccination Orthohepadnavirus Hepatic disease Infant Vaccine Infection Virus Hepatitis Mother Hepadnaviridae Viral disease Digestive diseases Vertical transmission Hepatitis B virus
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Summary:	The primary objective of this study was to estimate the efficacy of a recombinant hepatitis B vaccine (H-B-VAX™II) in preventing chronic hepatitis B infection when given alone without concomitant hepatitis B immune globulin (HBIG) to healthy Thai infants born of HBeAg-positive carrier mothers. The infants received a 0.5 ml (5 μg HBsAg) intramuscular injection of H-B-VAX™II either at birth, 1, and 6 months of age (Schedule A) or at birth, 1, 2, and 12 months of age (Schedule B). Blood drawings for the determination of hepatitis B virus (HBV) serologic markers were scheduled 4, 9, and 13 months following the initial dose of vaccine. At 13 months, 5 (10%) of 50 infants vaccinated on Schedule A and 7 (14.9%) of 47 infants vaccinated on Schedule B had experienced chronic HBV infection. Based on an expected infection rate in unimmunized infants of either 70 or 90%, the overall efficacy for both schedules combined was estimated to be 82.3% (95% CI: 70.6, 90.6) or 86.2% (95% CI: 77.1, 92.7), respectively. Corresponding schedule-specific estimates were for Schedule A: 85.7% (95% CI: 68.8, 95.3) or 88.9% (95% CI: 75.8, 96.3) and for Schedule B: 78.7% (95% CI: 59.6, 91.1) or 83.4% (95% CI: 68.6, 93.1). These results suggest that in areas of high endemicity, where mothers may not always be screened for HBV infection, routine vaccination of infants at birth with a course of hepatitis B vaccine alone should be highly protective, even for very high-risk infants of HBeAg-positive mothers.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-News-3
ISSN:	0264-410X 1873-2518
DOI:	10.1016/S0264-410X(02)00358-4