3种甲肝疫苗在儿童中应用的安全性及免疫效果观察

Observe of Immunogenicity Efficacy and Security of Three Kinds of Hepatitis A Vaccine

目的观察不同种类的甲型肝炎疫苗在儿童体内的接种反应及免疫效果。方法筛选2～3岁的甲肝易感儿童193人,分别接种进口灭活甲肝疫苗、国产灭活甲肝疫苗和国产冻干减毒甲肝疫苗,观察接种后48h内的局部反应和全身反应,并于完成免疫后1～2个月,采集血清标本检测抗-HAV-IgG抗体。结果193名观察对象在接种第1针和第2针后均未见严重不良反应,仅有4例出现轻微局部反应和全身反应。完成免疫接种后进口灭活甲肝疫苗、国产灭活甲肝疫苗和国产冻干减毒甲肝疫苗抗-HAV-IgG抗体阳转率分别为92.86%、67.61%和61.25%,GMT(ELASA法)平均滴度分别为1∶28.28、1∶53.39和1∶5.76。结论3种疫苗在儿童中的应用是安全的、有效的。

OBJECTIVE Compare the inoculate reaction and immunogenicity efficacy of three kinds of hepatitis A vaccines, to provide a scientific evidence for children＇s prevention from hepatitis A. METHOD 193 children of 2-3 years old, all were negative anti-hepatitis A virus （anti-HAV） antibody, were selected from Luohu District of Shenzhen. The children were all immunized with imported inactivated HA vaccine Havrix and home-made inactivated HA vaccine Healive and home-made freeze-dry live attenuated HA vaccine respectively. The local and the systemic adverse effects were observed after 48 hours of the vaccination, and the serum samples collected one or two months after the full inoculation were tested for the seroconvertion rate and geometric mean titers （GMT） of HAV antibodies. RESULT No severe adverse events occurred after the 1 st and 2nd dose Hepatitis A virus vaccination. Only some slight and temporary local and systemic reactions occurred on 4 children 48 hours after the vaccination. And the positive seroconversion rate of Havrix was 92.86%, the rate of Healive and freeze-dry were 67.61% and 61.25%, while the anti-HAV GMT was 1：28.28, 1：53.39 和1：5.76. CONCLUSION That the safety of these three kinds of hepatitis A vaccines are satisfaction.