风疹减毒活疫苗主种子批毒种(松叶株)的安全性和免疫原性检测

Detection of safety and immunogenicity of the live rubella vaccine from main seed virus strain (Matsuba strain)

评价兰州生物制品研究所用风疹病毒松叶株主种子批毒种制备的冻干风疹减毒活疫苗的安全性和免疫原性。采用自身对照、开放性的免疫原性临床观察试验,对100名8～10月龄筛选后符合条件的健康易感儿童,皮下接种1剂风疹减毒活疫苗,观察其免疫后的局部和全身反应并采集每个受试者免前和免后35d的血清标本,检测风疹HI抗体,计算阳转率和几何平均滴度。试验中所有受试者在系统观察期内均未观察到注射部位局部的不良反应;总的发热率为5%,且均为轻度发热;有1例在观察期内出现腹泻和咳嗽并持续5d,发生率为1%,属中度全身反应;血清风疹病毒抗体(HI)阳转率为100%,GMT为1:638.7±1.7。该疫苗与国内、外其它种类的风疹疫苗一样具有良好的安全性和免疫原性。

To evaluate the safety and irnmunogenieity of main seed virus strain based-Rubella vaccine { Rabbit kidney cell ） , originated from matsuba strain ,which was made in Lanzhou institute of biological products for children vaccination. Based on a self control and open-immunogenicity clinical obversative test, after the 100 health children aged between 8 to 10 months were qualified into the screening, each was inoculated subcutaneously one dose rubella vaccine for observing the later post-immunity local and systemic reactions. Each subject was later collected serum samples for 35days during pre-immunit-. and post-immunity respectively for detecting rubella HI-antibody, so as to get their positive rates and geometric mean titers. The results showed that none of the subjects are found adverse the observation perlod;the total fever rate is 5%, in the form of mild fever; one subject, accounting for 1% , is elinleally found diaherraing and coughing for 5 days during the peried, diagnostified as medium systemic reaction; The positive rate of rubella HI-antibody is 100%, followed by GMT at 1：638.7 1.7 levels. It＇s concluded that the live attenuated rubella vaccine is qualified and good for safety and immunity just like other Rubella vaccines at home and abroad.