Arbeter A M, Starr S E, Weibel R E, Plotkin S A
J Pediatr. 1982 Jun;100(6):886-93. doi: 10.1016/s0022-3476(82)80506-4.
Ninety-one healthy children were immunized with one of three preparations of the OKA strain of live attenuated varicella zoster virus in order to gain sufficient information on safety and immunogenicity to justify vaccine studies in immunosuppressed children. The OKA-Biken vaccine was studied in a dose response trial. Two additional clinical trails were conducted with the OKA strain that was further passaged: a frozen aqueous (OKA-RIT-Aq) form and a lyophilized (OKA-RIT-Ly) form were tested. With each of these vaccines clinical reactivity was minimal and virus shedding, viremia, and transmission of the vaccine virus were absent. Excellent seroconversion rates of 100 and 94% were induced with approximately 500 pfu of OKA-Biken and OKA-RIT-Ly vaccine, respectively. A lower seroconversion rate was noted for OKA-RIT-Aq, presumably on the basis of defective individual vials. Diluted OKA-Biken vaccine induced less seroconversion but even the 5 pfu dose produced antibody responses in 81% of the vaccinees. In vitro specific cellular immune responses to varicella virus antigens were demonstrated in each group of vaccinees, including all but two of those vaccines who failed to seroconvert. The data indicate that two preparations of the OKA strain are sufficiently safe and immunogenic in healthy children to support further studies in immunocompromised children.
91名健康儿童接种了三种减毒水痘带状疱疹病毒OKA株制剂中的一种，以便获取足够的安全性和免疫原性信息，为免疫抑制儿童的疫苗研究提供依据。对OKA-比克疫苗进行了剂量反应试验。对进一步传代的OKA株进行了另外两项临床试验：测试了冷冻水剂（OKA-RIT-Aq）形式和冻干（OKA-RIT-Ly）形式。使用这些疫苗中的每一种时，临床反应都很小，且不存在疫苗病毒脱落、病毒血症和传播情况。分别用约500 pfu的OKA-比克疫苗和OKA-RIT-Ly疫苗诱导出了100%和94%的优异血清转化率。OKA-RIT-Aq的血清转化率较低，可能是由于个别小瓶有缺陷。稀释的OKA-比克疫苗诱导的血清转化率较低，但即使是5 pfu剂量也在81%的接种者中产生了抗体反应。在每组接种者中都证明了对水痘病毒抗原的体外特异性细胞免疫反应，包括除两名未产生血清转化的接种者之外的所有人。数据表明，OKA株的两种制剂在健康儿童中足够安全且具有免疫原性，足以支持对免疫受损儿童进行进一步研究。
