甲型肝炎减毒活疫苗的免疫原性研究

A Study on Immunogenicity of Live Attenuated Hepatitis A Vaccine

为了对国产规范化的、滴度为 10 6 5TCID50 /ml的甲型肝炎 (甲肝 )减毒活疫苗 (H2 株 )的免疫原性进行研究 ,随机整群选取 3个不同地区的 1790名 3～ 7岁儿童 ,经检测抗甲肝病毒抗体 (抗 HAV)和乙型肝炎 (乙肝 )病毒表面抗原 (HBsAg)均为阴性的 4 13名儿童作为研究对象 ,按出生年月随机分为实验组 (单月 ) 2 0 7名和对照组 (双月 )2 0 6名 ,分别接种甲肝减毒活疫苗和乙肝疫苗 ,并对 2 0 7名实验组中的儿童随机抽取 10 0名儿童 ,在接种后 2～ 3d进行随访 ,观察接种甲肝减毒活疫苗后不良反应情况。于接种疫苗后 3个月和 12个月分别采集实验组和对照组部分观察对象血清标本 ,检测抗 HAV。结果显示 :实验组中的 10 0名儿童接种疫苗后 ,未见接种局部有明显红肿热痛、皮疹等反应 ,体温无明显增高 ,疫苗的安全性良好。实验组 3个月抗 HAV阳转率为 84 10 % ,1年阳性率为86 39% ,说明疫苗的免疫原性良好。在滴度为 10 6 5TCID50 /ml的剂量下 ,可推广使用。

In order to research the immunogenicity of live attenuated hepatitis A vaccines,which was standardized as 10 6.5 TCID 50 /ml, we selected 1790 children aged between 3 to 7 years in three different areas at random. After examining their anti-HAV and anti-HBsAg,we checked 413 children as our target,whose anti-HAV and anti-HBsAg were both negative. After that,according to their birth date,we divided them into two groups at random,test group that had 207 children and control group that had 206 children. They were inoculated with hepatitis A live attenuated vaccine and hepatitis B vaccine respectively. Then we selected 100 children among 207 ones of test group to observe their inoculation response after 2 to 3 days. Three and twelve months later,we examined the anti-HAV of the serum specimens from two groups. As a result,there was no side effect,such as obvious inflammation,fever or pain and rash in inoculated site. Their body temperature remained normal. This vaccine was secure. The anti-HAV positive senoconversion rate in test group was 84.10% after three months,and 86.39% after twelve months. Therefore,these illustrated that the immunogenicity of live attenuated hepatitis A vaccine is good. The dosage used as 10 6.5 TCID 50 /ml may be popularized.