首款国产重组乙型肝炎疫苗的临床安全性与有效性

Clinical safety and efficacy of first indigenous recombinant hepatitis B vaccine.

作者信息

Kumar A, Joshi N, Sreenivas D V, Palan S, Nagarjuna Kumar Y R

机构信息

Department of Gastroenterology, Nizam's Institute of Medical Sciences, Hyderabad.

出版信息

J Assoc Physicians India. 1998 Jul;46(7):620-2.

PMID:12152846

Abstract

A pilot study was conducted to assess the clinical safety and immunogenicity of an indigenously developed recombinant hepatitis B vaccine (Shanvac B) in 18 healthy adults. 20 microg of vaccine was administered at 0, 1 and 2 months. Protective anti HBs titres developed in 22%, 77% and 100% one month after 1st, 2nd and 3rd dose of vaccination, respectively. The geometric mean titre after the 3rd dose was 1015.29 mIu/ml. The vaccine was well tolerated with minor local and systemic side effects in 28% and 22%, respectively. The indigenously developed recombinant hepatitis B vaccine is safe, well tolerated and highly immunogenic.

摘要

开展了一项初步研究，以评估一种自主研发的重组乙型肝炎疫苗（山沃克B）在18名健康成年人中的临床安全性和免疫原性。在0、1和2个月时分别接种20微克疫苗。在接种第一剂、第二剂和第三剂疫苗后1个月，产生保护性抗-HBs滴度的比例分别为22%、77%和100%。第三剂接种后的几何平均滴度为1015.29 mIu/ml。该疫苗耐受性良好，分别有28%和22%的受试者出现轻微的局部和全身副作用。自主研发的重组乙型肝炎疫苗安全、耐受性良好且免疫原性高。