Field evaluation of the efficacy and immunogenicity of recombinant hepatitis B vaccine without HBIG in newborn Vietnamese infants

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.