title: Protective efficacy of hepatitis B vaccine without HBIG in infants of HBeAg-positive carrier mothers in Thailand.
abstract: The primary objective of this study was to estimate the efficacy of a recombinant hepatitis B vaccine (H-B-VAXII) 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 micro g HBsAg) intramuscular injection of H-B-VAXII 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.
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Ramathabodi Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Somsak
authors.initials: S
authors.lastname: Lolekha
authors.forename: Boonyarat
authors.initials: B
authors.lastname: Warachit
authors.forename: Amporn
authors.initials: A
authors.lastname: Hirunyachote
authors.forename: Piyaporn
authors.initials: P
authors.lastname: Bowonkiratikachorn
authors.forename: David J
authors.initials: DJ
authors.lastname: West
authors.forename: Gabriele
authors.initials: G
authors.lastname: Poerschke
mesh_terms: D001034:Apgar Score; D002353:Carrier State / Q000276:immunology* / Q000628:therapy / Q000821:virology; D005260:Female; D006509:Hepatitis B / Q000097:blood / Q000517:prevention & control* / Q000635:transmission; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D006513:Hepatitis B e Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D017589:Immunization Programs; D007115:Immunization Schedule; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000627:therapeutic use; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D016896:Treatment Outcome; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
chemical_list: D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D007136:Immunoglobulins; D014614:Vaccines, Synthetic; C045213:hepatitis B hyperimmune globulin