Several million people world-wide are infected with hepatitis B virus. The infection may cause serious short-term and long-term effects including portal hypertension, liver failure, liver cancer, and death. Hepatitis B vaccination is reported to be beneficial in some specific groups of people such as babies born to women infected with hepatitis B, health-care workers, and people with long-standing kidney failure. Whether hepatitis B vaccine is beneficial in people who have not been exposed to hepatitis B infection or those whose exposure status is not known is assessed in the present review.

Twelve randomised clinical trials fulfilled the inclusion criteria of this review. Primary analysis of the data based on criteria described beforehand (intention-to-treat model assigning unfavourable outcome for missing data) showed that hepatitis B vaccination has an unclear effect on the risk of developing hepatitis B infection. Analysis of data of available participants in the various trials showed that as compared to not vaccinating, hepatitis B vaccination reduces the risk of developing hepatitis B infection; by 88% for hepatitis B surface antigen marker and 62% for anti-core antibody marker. One should note, that these findings are based on only four randomised clinical trials of poor methodological quality involving 1230 participants. When compared with other vaccines or placebo, hepatitis B vaccination results in comparable risk of developing adverse events. This includes serious adverse events such as admission to hospital and convulsions, as well as less serious events such as fever, local redness, and pain. This shows that the risk of developing these adverse events is not more than with other vaccinations. There was not enough data to draw definite conclusions on the effect of hepatitis B vaccination on compliance and cost-effectiveness.