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Evaluation of immunogenicity and reactogenicity of recombinant DNA hepatitis B vaccine produced in India

World Journal of Gastroenterology 2005年第45期11卷 7165-7168页

作者： Zahid Hussain Syed S Ali Syed A Husain Mohammad Raish Deepika R Sharma Premashis Kar PCR Hepatitis Laboratory Panacea Biotec Ltd Mohammad Raish

AIM：（1） To gain information on immune responses to an accelerated schedule of 0, 1, and 2 mo in paramedical staff and BDS students who are at an increased risk of getting hepatitis B infection and come under high risk groups. （2） To assess the efficacy and safety of En/vac- HB in different age groups, using genetically modified yeast strain Pichia pastoris, a new recombinant hepatitis B accine developed and manufactured in India. METHODS： A prospective, comparative, and single blinded trial of rapid （0, 1, and 2 mo） hepatitis B immunization schedulewas reported. A total of three hundred and seven （212 females and 95 males） healthy volunteers divided into three age groups （18-29, 30-39, and 40-49） were enrolled after screening for markers of hepatitis B. All the volunteers received 20 mg of the vaccine intramuscularly at 0, 1, and 2 mo. RESULTS： Geometric mean titers were calculated pre and post vaccination. Before immunization the GMT was 0.0124 mIU/mL. One month after the administration of the third dose of recombinant vaccine 296/307 （96.5%） subjects achieved seroprotective levels of anti-HBs. The geometric mean anti-HBs titers achieved after one month of the third dose was 2 560.0 mIU/mL. The geometric mean anti-HBs titer of males was 2 029.0 mIU/mL, while that of the females was 2 759.0 mIU/mL. In the age group of 18-29 years, anti-HBs titer was 3 025.0 mIU/ mL, while that in the age group of 30-39 years was 2 096.0 mlU/mL. In third age group of 40-49 years, anti- HBs titer was 1 592.0 mIU/mL. Hyper-responses （anti-HBs≥100 mIU/mL） were shown in 88.0% （271/307） of subjects. Eleven （3.5%） subjects responded poorly to the vaccine in the age group of 40-49 years. There was only mild pain at the site of injection otherwise there were no other adverse drug reactions （ADRs）. CONCLUSION： This vaccine （Enivac-HB） is safe and efficacious, providing significant protection after the third dose and rapid hepatitis B immunization schedule of 0, 1, and 2 mo can be recommended

关键词： Enivac-HB Pichia pastoris anti-hbsantibody Hepatitis B vaccine

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