title: Multicenter trial on the efficacy of HBIG and vaccine in preventing perinatal hepatitis B. Final report.
abstract: In an attempt to interrupt perinatal transmission of hepatitis B, 92 infants born to HBsAg carrier mothers (49 to HBeAg-positive mothers, 30 to anti-HBe-positive with abnormally elevated ALT levels, and 13 to HBeAg/anti-HBe-negative mothers) received 0.5 ml/kg BW of HBIG at birth and at 1 month of age. Three IM injections of hepatitis B vaccine were given at 3, 4, and 9 months of life. All babies who were given the three doses of vaccine developed an active anti-HBs response: of these, 53 (62.3%) had antibody titers higher than 1,000 mIU/ml, 29 (34.2%) had levels between 100 and 1,000 mIU/ml, and the other three (3.5%) were below 100 mIU/ml. At the end of the 2-year follow-up, these three poor responders became anti-HBs negative, whereas the others still had antibody. All but three babies were protected by HBIG plus vaccine treatment. Two chronic HBV infections occurred within 6 months of life presumably because the babies were already infected when prophylaxis started. The third baby became an HBsAg carrier at 9 months of age in spite of a previous response to the vaccine. Simultaneous presence of HBsAg of y specificity and anti-HBs (anti-a) was still detectable at 24 months of age. The vaccine was well tolerated. Passive plus active immunization is an effective procedure for preventing perinatally transmitted HBV infection.
mesh_terms: D002353:Carrier State / Q000276:immunology; D002986:Clinical Trials as Topic; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control* / Q000635:transmission; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000032:analysis; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens / Q000032:analysis; D003699:Hepatitis D / Q000276:immunology; D006801:Humans; D007110:Immunity, Active; D007116:Immunization, Passive; D007136:Immunoglobulins; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D014611:Vaccination; D014761:Viral Hepatitis Vaccines / Q000276:immunology
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D007136:Immunoglobulins; D014761:Viral Hepatitis Vaccines; C045213:hepatitis B hyperimmune globulin