Comparison of three different recombinant hepatitis B vaccines:GeneVac-B,Engerix B and Shanvac B in high risk infants born to HBsAg positive mothers in India

作     者：Vijayakumar Velu Subhadra Nandakumar Saravanan Shanmugam Suresh Sakharam Jadhav Prasad Suryakant Kulkarni Sadras Panchatcharam Thyagarajan 

作者机构：Department of Medical Microbiology Dr ALM PGIBMS University of Madras Chennai 600113 and National referral Centre for viral hepatitis India Vaccine Research Centre Department of Microbiology and Immunology Emory University Atlanta Georgia 30329 United States Department of Medical Microbiology Dr ALM PGIBMS University of Madras Chennai 600113 and National referral Centre for viral hepatitis India Department of Medical Microbiology Dr ALM PGIBMS University of Madras Chennai 600113 and National referral Centre for viral hepatitis India YRG Centre for AIDS Research and Education VHS campus Taramani Chennai 600113 India Serum Institute of India Ltd Pune India 

出 版 物：《World Journal of Gastroenterology》 (世界胃肠病学杂志（英文版）)

年 卷 期：2007年第13卷第22期

页      面：3084-3089页

核心收录：

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1002[医学-临床医学] 100401[医学-流行病与卫生统计学] 10[医学] 

基　　金：ThevaccinesandfinancefortheclinicalstudywereprovidedbySerumInstituteofIndiaLimited Pune India 

主　　题：重组乙型肝炎疫苗 印度 新生儿 HBsAg阳性 母亲 免疫效果 免疫接种 

摘      要：AIM: To evaluate a low cost Indian recombinant hepatitis B vaccine GeneVac-B for its immunogenicity and safety in comparison to Engerix B and Shanvac B vaccine in high risk newborn infants born to hepatitis B surface antigen (HBsAg) positive mothers. METHODS: A total of 158 infants were enrolled in the study. Fifty eight infants were enrolled in the GeneVac-B group while 50 each were included for Engerix B and Shanvac B groups. A three-dose regimen of vaccination; at birth (within 24 h of birth), 1st mo and 6 mo. were adopted with 10 μg dosage administered uniformly in all the three groups. Clinical and immunological parameters were assessed for safety and immunogenicity of the vaccines, in all the enrolled infants. RESULTS: Successful follow up until seven months of age was achieved in 83/ (48/58) for GeneVac-B, 76/ (38/50) and 64/ (32/50) for Engerix B and Shanvac B groups respectively. 100/ seroconversion and seroprotection was achieved in all the three groups of infants. The geometric mean titers of anti-HBs one month after the completion of three dose of vaccination were 90.5, 80.9 and 72.5 mIU/mL in GeneVac-B, Engerix B and Shanvac B vaccine group respectively. Furthermore the level of anti-HBs increases with age ofbabies who were born to HBsAg positive mothers. The GMT values of anti-HBs were 226.7, 193.9 and 173.6 mIU/mL respectively in GeneVac-B, Engerix B and Shanvac B groups one year after the completion of the three doses of vaccine. No systemic reactions were reported in infants during the entire vaccination process of GeneVac-B and the other two vaccines. Clinical safety parameters remained within the normal limits throughout the study ***: The study concludes that there is no significant difference between the three recombinant hepatitis B vaccines. Administration of these vaccines within 24 h of birth to babies, born to HBsAg positive mothers will reduce the incidence of HBV infection.