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Multicenter trial on the efficacy of HBIG and vaccine in preventing perinatal hepatitis B. Final report
Author(s) -
Zanetti A. R.,
Dentico P.,
Del Vecchio Blanco C.,
Sagnelli E.,
Villa E.,
Ferroni P.,
Bergamini F.
Publication year - 1986
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.1890180405
Subject(s) - virology , medicine , multicenter study , randomized controlled trial
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.