Xu Zhiyi, Wang Xuanyi, Li Rongcheng, Meng Zongda, Zhang Yong, Gong Jian, Ma Jingchen, Li Yanting, Zhao Shoujun, Li Yanping, Zhao Yuliang, Huang Quancheng, Luo Dong, Xia Jianling, Liu Hongbin, Liu Xinli, Ouyang Peiying
Department of Epidemiology, School of Public Health, Fudan University, Shanghai 200032, China.
Zhonghua Yi Xue Za Zhi. 2002 May 25;82(10):678-81.
To assess the efficacy and immunogenicity of two live attenuated hepatitis A vaccines.
Randomized and controlled clinical trials were conducted in Guanxi, Hebei and Shanghai, 457 251 children were enrolled. The efficacy for preventing clinical hepatitis A was calculated by the comparison of incidence rate of disease between vaccine group and control group. Susceptible subjects tested anti-HAV negative before the study were followed up after vaccination for determination of the immunogenicity and vaccine efficacy to prevent subclinical infection.
The protective efficacy to prevent clinical infection by both H(2) and LA-1 vaccines were 95%. The peak of seroconversion was observed in 94.9% and 86.0% respectively for the two vaccines. The seroconversion rate decreased to 75% approximately 80% in the third year, but the vaccine protection against clinical hepatitis A has remained unchanged throughout the 3 years.
Both strains of the live attenuated hepatitis A vaccines have good immunogenicity and high protection against clinical disease, the efficacy to prevent subclinical infection is not significant. The subclinical HAV infection serves as a natural booster for the vaccinees.
评估两种甲型肝炎减毒活疫苗的有效性和免疫原性。
在广西、河北和上海开展随机对照临床试验,纳入457251名儿童。通过比较疫苗组和对照组的发病率来计算预防临床甲型肝炎的有效性。研究前抗甲型肝炎病毒(HAV)检测为阴性的易感受试者在接种疫苗后进行随访,以确定免疫原性和预防亚临床感染的疫苗效力。
H(2)和LA - 1疫苗预防临床感染的保护效力均为95%。两种疫苗的血清转化率峰值分别为94.9%和86.0%。在第三年,血清转化率分别降至约75%和80%,但疫苗对临床甲型肝炎的保护作用在3年中保持不变。
两种甲型肝炎减毒活疫苗株均具有良好的免疫原性,对临床疾病具有高度保护作用,预防亚临床感染的效力不显著。亚临床HAV感染可作为疫苗接种者的自然加强免疫。