Comparative Evaluation of Four Hepatitis B vaccines available in Pakistan: Reactogenicity and Immunogenicity
Aim: Main objective of this study was to evaluate the immunogenicity of hepatitis B vaccines commonly available in the Pakistan’s market. For this purpose, we compared immunogenicity and reactogenicity of four recombinant hepatitis B vaccines in apparently healthy young female volunteers in Karachi. Introduction: Today most of the world’s people recognize the importance of vaccination and more than 80% of the world children are now immunized against diseases covered by EPI (expended program on immunization). The Hepatitis B vaccines have been available since 1982 and more than one billion doses have been used. Approximately 100 countries, consistent with World Health Organization policy, have added HB vaccination to their routine childhood immunization programs. Infect many developing countries have scored astonishing success in controlling communicable diseases through mass vaccination and environmental sanitation. Materials and Methods: A total of 243 apparently young healthy female students of two Universities of the city were included in this study performed during Jan 2003 to Jan 2006, after receiving written informed consent. Four recombinant yeast derived HB vaccine were used as test regimens i.e. Euvax-B (LG Chemicals Ltd., Korea), Heptis-B (Boryang, Korea), Amvax-B (Amson, Pakistan) and Engerix-B (GS & K, Belgium). Participants were injected with the vaccine of their own choice. Information broachers of the four vaccines were distributed among participants to help them make a choice. anti-HBV antibody titres were recorded using EILSA (IMX-ELISA, Abbott). Results: A total of 243 HBV and HCV negative individuals came forward with the interest for immunization with the Hepatitis B vaccine of their own choice. Out of total 729 doses administered to 243 individuals during this study (Jan’2003 – Jan’2006) ……, 195 were of Engerix-B, 420 were Heptis-B, 75 were Amvax-B, and 39 doses were of Euvax-B. Among these four candidate vaccines Engerix-B came up with the least adverse effects, Euvax-B and Heptis-B showed moderate level of side effects, while Amvax-B showed maximum level of side effects. Although, none of these vaccines showed very sever type of adverse effects like demylination or central nervous system disorders during last 05 years period, except soreness, indurations, swelling, redness, mild pain, granuloma formation, and mild fever at the time of injection or just after injecting the vaccine, which was recovered within couple of hours. Conclusion: Overall serum protection rate achieved in case of Engerix-B was 95.9%, in case of Euvax-B, it was 95.2%, in case of Heptis-B was 95.0% , and in case of Amvax-B it was 95.1%, which fulfils the WHO requirements for a hepatitis B vaccine (i.e. seroprotection rate of > 95%), P values observed were lesser than 0.05 indicating significance of the vaccines and good safety profile in subjects.