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Myanmar Health Sciences Research Journal, Volume 29, Issue 2, 2017, pp. 146-150

Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Produced by Beijing Tiantan Biological Products, China

Abstract :

Hepatitis B infection is an important public health problem all over the world. Vaccination is undoubtedly the method of choice to prevent hepatitis B. The aim of the study was to assess the safety and immunogenicity of the recombinant hepatitis B vaccine produced by Beijing Tiantan Biological Products Co. Ltd, China. Forty-five healthy volunteers, aged 18 to 38 years, whose laboratory investigations were within normal limits, were enrolled in the trial. They included 8 males (17.8%) and 37 females (82.2%). They were given 20 µg of trial vaccine in a 3-dose vaccine series at 0, 1 and 2 months. Only 3/45 subjects (6.7%) reported local/systemic reactions such as pain at the injection site and headache on the day of first vaccination. They were mild and self limited. Both ECG and laboratory abnormalities were not detected at one week after the first vaccination. Sera to determine antibody titers were evaluated at one and a half month after the third dose to determine immunogenicity/protective antibody response (≥10 mIU/ml). Immunogenicity was found in 44/45 subjects (97.8%). Therefore, the yeast derived recombinant hepatitis B vaccine produced by Beijing Tiantan Biological Products Co. Ltd, China using 20 µg in 0, 1 and 2 months rapid schedule was proven to be totally safe and highly immunogenic. This vaccine can be used safely in young adults and adults.

Keywords : Safety, Immunogenicity, Hepatitis B vaccine
Subject Area : Health Professions(all) Medicine(all) Social Sciences(all) Immunology and Microbiology(all) Pharmacology, Toxicology and Pharmaceutics(all)

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