An open study to assess the safety and efficacy of Heprovac-B vaccine 10 mcg-dose for adults.

Heprovac B is a novel recombinant vaccine. There are many vaccines available in Pakistani market but Heprovac B claims to be immunogenic even at 10 meg dose. Aim of the study is to determine whether using 10 meg of Heprovac B vaccine is safe and effective in producing sufficient immunity in Pakistani population. One hundred and twenty five subjects, who fulfilled the Inclusion criteria, were enrolled for the study. Heprovac B was administered in a three-dose regimen given at 0, 1 and 6 months and adverse events were recorded. Immunogenicity was tested by measuring hepatitis B surface antibody one month after each dose received. One month after the 3rd dose 98.7% of the subjects were found to be seroprotected with geometric mean titer of 488.83 mIU/1 after the third dose. Heprovac B, vaccine was well tolerated with minimal reported adverse events. It is safe and 10 mcg is immunogenic in producing antibodies in Pakistani population against Hepatitis B virus.