Immunogenicity and safety of a new inactivated hepatitis A vaccine: A clinical trial with comparison of administration route
Immunogenicity and safety of a new inactivated hepatitis A vaccine: A clinical trial with comparison of administration route
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DOI：
10.1016/0264-410x(96)00044-8
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发表时间：
1996-08-01
期刊：
影响因子：
5.5
通讯作者：
Lafaix, C
中科院分区：
文献类型：
--
作者：
Fisch, A;Cadilhac, P;Lafaix, C
开展了一项双中心、随机对照开放试验，以比较不同给药途径（肌肉注射（i.m）、皮下注射（s.c）和无需使用喷射注射器装置注射）下巴斯德梅里埃灭活疫苗对成人的免疫原性和反应原性。对147名血清阴性受试者，间隔6个月分两剂接种疫苗，每次访问时采用改良放射免疫测定法测定抗甲型肝炎病毒（HAV）滴度。第一次给药后，除1例血清转化（s.c）外，138例受试者。强化鼻后，所有受试者均表现出高水平的甲肝抗体。喷射给药方式滴度最高(首次给药后滴度为305 mIU ml(-1)，加强给药后滴度为3727 mIU ml(-1))，其次是i.m.给药方式（210 mIU ml（-1）、3152 mIU ml(-1)）和s.c.给药方式（165 mIU ml（-1）、2082 mIU ml(-1)）。在三种配对比较（i.m.与喷射注射器、喷射与s.c、im与s.c）中，没有观察到统计学上的显著差异。这种甲型肝炎灭活疫苗在单次注射和6个月后一次加强后表现出高度的免疫原性。版权所有爱思唯尔科学有限公司
A bicentre, controlled randomized open trial was carried out in order to compare the immunogenicity and the reactogenicity of PASTEUR MERIEUX Serums et Vaccins inactivated Hepatitis A Vaccine on adults, when used with different routes of administration [intramuscular (i.m.), subcutaneous (s.c.) and needless injection using a Jet injector device]. Vaccines were given at two doses 6 months apart to 147 seronegative subjects, Anti-Hepatitis A virus (HAV) titres were performed at each visit by modified radioimmunoassay assay. After the first dose, 138 subjects except one seroconverted (s.c.). After booster nose, all subjects exhibited high levels of HAV antibodies. The higher titres were observed with Jet injector (GMT: 305 mIU ml(-1) after the first dose and 3727 mIU ml(-1) after the booster dose;), followed by the i.m. route (210 mIU ml(-1), 3152 mIU ml(-1)) and the s.c. route (165 mIU ml(-1), 2082 mIU ml(-1)). No statistically significant differences were observed in the three paired comparisons (i.m. vs jet injector; jet vs s.c., im vs s.c.). This inactivated hepatitis A vaccine appeared to be highly immunogenic after one single dose and one booster 6 months later. Copyright (C) 1996 Elsevier Science Ltd.