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本研究应用严格双盲,随机分组内对照的方法。对我国研制的H2株、L-A-1株两种甲肝减毒活疫苗进行同质基础上的免疫效果比较研究。共接种观察了经严格筛选后6-10岁学龄儿重1220名,采取免疫后2.4.8周血1210人份,用ELISA竞争抑制法检测HAVAb,计算Cutoff值,各组之间经统计学处理进行比较,结果表明,两种甲肝疫苗安全性良好,副作用低,但免疫后2、4、8周血检出的抗NAVA650%抑制率和40%抑制率,疫苗组与对照组之间无差别。
This study used a strict double-blind, randomized grouping of controls. The two groups of attenuated live attenuated hepatitis A (H-2 and L-A-1) strains developed in China were compared on the basis of homogeneity. A total of 1220 school-age children weighing 6 to 10 years were screened and 1210 were immunized after 2.4.8 weeks of immunization. HAVAb was assayed by ELISA competitive inhibition and the Cutoff value was calculated. The results showed that two kinds of hepatitis A vaccine had good safety and low side effects. However, the anti-NAVA650% and 40% inhibition rates of blood samples detected at 2, 4 and 8 weeks after immunization were significantly lower than those of the control group No difference.