kvaluation of the immunogenicity of a hepatitis B recombinant vaccine as used on healthy adult women

Abstract

A hepatitis B antivirus pilot study was carried out to evaluate HEPRECOMB BERNA@ recombinant vaccine immunogenicity and the adverse effects which can be attributed to the vaccine and its application by using and comparing two different doses administered to healthy individuals who presented no clinical evidence of hepatic disease, no serological evidence of hepatic disease and no serological evidence of previous contact with HBV (Hepatitis B virus).The humoral in vivo response induced by the application of the vaccine was also monitored; 49 female volunteers from Santafé de Bogotá were included in the study and randomly divided into two groups. Group 1 was vaccinated with three 20 yg doses, whilst group 2 received three 10 ~g doses. In both groups the 0, 1 and 6 month scheme was used and women were observed for a period of 16 months.The inclusion criteria were: voluntary participation, 18 years or older and absence of anti HBsAg. Antibody titre was significantly greater in group 2 at 2"" and dth month of observation even though the titres were even at the end of the 71h and 16lh months. The present study concludes that the hepatitis B antivirus recombinant vaccine HEPRECOMB BERNA@ given in 10pg doses has a greater response in the first 2 months of observation than 2 0 ~ 9do ses, similar results being found at the end of the seventh month.The recommendation is that studies should be done on bigger populations.