Because of the high prevalence of hepatitis B virus (HBV) infection in The Gambia, HBV vaccination has been incorporated into the national expanded programme on immunisation. We have assessed the efficacy of the vaccine against HBV infection and chronic carriage by examining 720 3-4-year-old children who had received the vaccine in infancy and 816 who had not received it. The vaccine was 84% (95% CI 78-89%) effective against infection and 94% (84-98%) effective against chronic carriage. Vaccinated infants of mothers positive for hepatitis B surface and e antigens were at greater risk of breakthrough infection and chronic carriage than infants of uninfected mothers. The high vaccine efficacy against the HBV carrier state, the main risk factor for the development of chronic liver disease and liver cancer, offers hope that the prevalence of these diseases may be reduced in the future.
PIP: As part of the Gambia Hepatitis Intervention Study, hepatitis B antigens and antibodies were assayed in 720 3-4 year old children who had received 4 doses of 10 mcg plasma-derived hepatitis B vaccine in infancy, the findings were compared with 816 controls. The cross sectional study took place from September, 1990, to July, 1991. Study subjects were tested for hepatitis B core antigen (HBcAg), as well as antigens and antibodies to hepatitis surface, e, and core protein, and those testing positive were tested a year later for HBsAg to determine chronic carrier status. Children negative for core antibody and surface antigen were considered uninfected; those positive for core antibody were considered infected; those positive for surface antigen 2 times 6 months apart were considered carriers. 4.6% of the vaccinated children were infected, and 0.6% were chronic carriers. 3 of these carriers had infected or carrier mothers, and 1 had only received 1 dose of vaccine. In the controls, there were 29% judged infected by anti-HBc, including 13% who were also positive for HBsAg. 86% of these were considered chronic carriers when tested a year later. Thus the vaccine was estimated to be 84% effective against infection and 94% effective against chronic carriage. The current Gambian vaccine consists of 2.5 mcg recombinant hepatitis B vaccine.