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以BRD-2疫苗株制备的三批风疹疫苗(滴度分别为5.25、5.75、5.50TCID50/0.5ml),分别在风疹抗体阴性的799名2~6岁儿童和167名女青年中做了临床反应性和免疫原性观察。在儿童中,三批疫苗的发热率分别为2.43%、0%和2.17%,对照组为2.78%,无高热反应。在女青年中发热率分别为0%、1.72%和2.08%,对照组为2.0%,未出现高于38℃的中热反应,未见有皮疹、淋巴结肿大、咽喉红肿、关节痛等反应。在儿童中,三批疫苗的抗体阳转率为100%、98.67%和100%,GMT±SD分别为57.67±2.347,102.54±2.33和110.41±1.94。在女青年中,抗体阳转率分别为100%、98.28%和100%,GMT±SD分别为58.44±2.17、65.55±2.46和65.88±2.1。疫苗稀释100倍后,在儿童中其抗体阳转率可达91.91%,GMT46.9±3.543,疫苗稀释1万倍后(约32TCID50)其抗体阳转率仍有61.7%。
Three batches of rubella vaccine (titers of 5.25, 5.75 and 5.50 TCID50 / 0.5 ml respectively) prepared with the BRD-2 vaccine strain were administered to 799 children aged 2-6 years and 167 Young women made clinical reactivity and immunogenicity observations. Among children, the fever rates for the three batches of vaccines were 2.43%, 0% and 2.17% respectively, compared with 2.78% in the control group, with no hyperthermia response. In young women, the rates of fever were 0%, 1.72% and 2.08%, respectively. The control group was 2.0%. There was no moderate fever above 38 ℃. No rash, lymphadenopathy and throat Redness, joint pain and other reactions. Among children, the antibody positive rates for the three batches of vaccines were 100%, 98.67%, and 100% with GMT ± SD of 57.67 ± 2.347, 102.54 ± 2.33 and 110.41 ± 1.94, respectively . In young women, the antibody positive rates were 100%, 98.28% and 100%, respectively, and GMT ± SD were 58.44 ± 2.17, 65.55 ± 2.46 and 65.88 ± 2.1 . After the vaccine was diluted 100-fold, the antibody positive rate in children was 91.91% and the GMT was 46.9 ± 3.543. After the vaccine was diluted by 10,000 times (about 32TCID50), the antibody positive rate was still 61.7% .