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健康儿童水痘疫苗试验。比较研究与随访研究综述。

Varicella vaccine trials in healthy children. A summary of comparative and follow-up studies.

作者信息

Arbeter A M, Starr S E, Preblud S R, Ihara T, Paciorek P M, Miller D S, Zelson C M, Proctor E A, Plotkin S A

出版信息

Am J Dis Child. 1984 May;138(5):434-8. doi: 10.1001/archpedi.1984.02140430012004.

DOI:10.1001/archpedi.1984.02140430012004
PMID:6324570
Abstract

Beginning in 1979, OKA and KMcC strains of varicella zoster virus (VZV) vaccine were administered to 369 healthy seronegative children in a sequence of ten comparative clinical trials. Postimmunization clinical reactivity was minimal with the OKA vaccines but was unacceptably high (32%) with the KMcC passage-40 vaccine. Ninety-three percent to 100% immunogenicity was noted by fluorescent antibody assay and in vitro lymphocyte proliferation to VZV antigens. Follow-up studies demonstrated persistence of antibody and in vitro lymphocyte proliferation responses and protection or modification of infection nine to 48 months after immunization. Only five episodes of mild varicella occurred in children in whom seroconversion had occurred. These episodes were noted after at least 281 known varicella exposures. Vaccine virus reactivation as zoster had not occurred in any child.

摘要

从1979年开始,水痘带状疱疹病毒(VZV)疫苗的OKA株和KMcC株在十项比较性临床试验中接种给了369名健康的血清阴性儿童。接种OKA疫苗后临床反应极小,但接种KMcC传代40疫苗后的反应高得令人无法接受(32%)。通过荧光抗体检测和体外淋巴细胞对VZV抗原的增殖反应,观察到免疫原性为93%至100%。随访研究表明,抗体和体外淋巴细胞增殖反应持续存在,并且在免疫后9至48个月对感染有保护或改善作用。血清转化的儿童中仅发生了5例轻度水痘。这些病例是在至少281次已知的水痘暴露后发现的。任何儿童均未发生疫苗病毒再激活为带状疱疹的情况。

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