Multicenter trial on the efficacy of HBIG and vaccine in preventing perinatal hepatitis B. Final report

✍ Scribed by Prof. A. R. Zanetti; P. Dentico; C. Del Vecchio Blanco; E. Sagnelli; E. Villa; P. Ferroni; F. Bergamini

• Publisher: John Wiley and Sons
• Year: 1986
• Tongue: English
• Weight: 473 KB
• Volume: 18
• Category: Article
• ISSN: 0146-6615
• DOI: 10.1002/jmv.1890180405

✦ Synopsis

f. V), Italy

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, OOO mIU/ml, 29 (34.2%) had levels between 100 and 1, OOO 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.