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目的 观察国产甲型肝炎 (甲肝 )减毒活疫苗 (H2 株与LA 1株 )的免疫原性及预防效果。方法 在广西、河北、上海等地 4 5 72 5 1例观察对象中进行随机对照试验 ,比较接种疫苗组与对照组甲肝发病率 ,观察疫苗保护效果 ;并筛选易感者 ,观察疫苗接种后发生甲肝感染的转归及免疫后甲肝抗体阳性率与持久性。结果 H2 株 (10 7.0 TCID50 )与LA 1株 (10 6.75TCID50 )疫苗保护效果均达 95 % ,抗体阳转率峰值分别出现在疫苗接种后 2个月与 6个月 ,为 94 .9%与 86 .0 % ,3年后抗体阳性率下降至 75 %～ 80 % ,但保护效果不变。结论 国产甲肝减毒活疫苗 (H2 株与LA 1株 )具有很好免疫原性与保护效果 ,可与国外灭活疫苗相媲美。接种者可通过隐性感染获得加强免疫。
Objective To observe the immunogenicity and prophylactic effect of live attenuated hepatitis A (Hepatitis A) vaccine (H2 strain and LA 1 strain). Methods Randomized controlled trials were conducted among 457251 subjects in Guangxi, Hebei and Shanghai. The incidence of hepatitis A in vaccinated and control groups was compared to observe the protective effect of the vaccine. Susceptible persons were screened and observed after vaccination Hepatitis A infection and post-immune hepatitis A antibody positive rate and persistence. Results The protective efficacy of the vaccine against both H2 10 (10 7.0 TCID50) and LA 1 (10 6.75 TCID50) was 95%. The peak of antibody positive rate appeared 94.9% at 2 months and 6 months after vaccination 86.0%, 3 years after the antibody positive rate dropped to 75% to 80%, but the same protection. Conclusion Live attenuated live attenuated hepatitis A vaccine (H2 strain and LA 1 strain) has good immunogenicity and protective effect, comparable with foreign inactivated vaccine. Inoculants can be boosted by latent infection.