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Field evaluation of the efficacy and immunogenicity of recombinant hepatitis B vaccine without HBIG in newborn Vietnamese infants
Author(s) -
Milne Alexander,
West David J.,
Chinh Dang Van,
Moyes Chris D.,
Poerschke Gabriele
Publication year - 2002
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.10071
Subject(s) - virology , immunogenicity , medicine , vietnamese , recombinant dna , biology , immunology , antibody , genetics , gene , linguistics , philosophy
A study involving more than 2,000 infants was conducted in Vietnam to assess the field effectiveness and immunogenicity of recombinant hepatitis B vaccine given at birth, 1 month, 2 months, without concomitant hepatitis B immune globulin (HBIG). All received a 5 μg dose of H‐B‐VAX™II at birth. Infants born to non‐carrier mothers (Group 1; N = 1798) then received 2.5 μg doses at 1 and 2 months of age, while infants of HBeAg‐negative (Group 2; N = 125) or HBeAg‐positive (Group 3; N = 88) carrier mothers received 5 μg doses. No Group 1 or 2 vaccinees were infected. In Group 3, 12 (14.6%) of 82 infants did become infected (estimated efficacy 84%). 98.0–98.6% of uninfected infants who were tested for anti‐HBs developed a seroprotective concentration ≥ 10 IU/L. In hyperendemic Vietnam, where routine maternal screening and passive‐active prophylaxis of high‐risk infants with vaccine plus HBIG is not feasible, administration of vaccine alone to all newborns may control effectively HBV infection. J. Med Virol. 67:327–333, 2002. © 2002 Wiley‐Liss, Inc.