冻干水痘减毒活疫苗（Varivax®）的双盲、随机、对照、多中心安全性和免疫原性研究
A double-blind, randomized, controlled, multi-center safety and immunogenicity study of a refrigerator-stable formulation of VARIVAX®.
机构信息
Primary Physicians Research, Pittsburgh, PA, United States.
Merck & Co., Inc., Kenilworth, NJ, United States.
出版信息
Vaccine. 2019 Sep 10;37(38):5788-5795. doi: 10.1016/j.vaccine.2018.01.089. Epub 2018 Aug 23.
OBJECTIVE
VARIVAX® (varicella virus vaccine, live Oka/Merck, Merck & Co., Inc., Kenilworth, NJ, USA) was originally licensed as a frozen formulation. A refrigerator-stable formulation of VARIVAX was subsequently developed to allow for increased availability of the product around the world. The objective of this study (V210-051) was to demonstrate that the safety, tolerability and immunogenicity profile of the refrigerator-stable formulation of VARIVAX was similar to the frozen formulation.
METHODS
In this double-blind, randomized, multicenter study, healthy 12- to 23-month-old children with negative vaccination and clinical histories for measles, mumps, rubella, varicella, and zoster were vaccinated with either a refrigerator-stable formulation of VARIVAX (at two dosage levels; 8000 PFU [N = 320] or 25,000 PFU [N = 315]) or the frozen formulation of VARIVAX (10,000 PFU, N = 323) given concomitantly with M-M-RII® (measles, mumps, and rubella virus vaccine live, Merck & Co., Inc., Kenilworth, NJ, USA). Children were followed for 42 days after vaccination for adverse experiences. Immunogenicity was evaluated 6 weeks after vaccination.
RESULTS
The refrigerator-stable formulation of VARIVAX was generally well tolerated. The incidence of adverse experiences was similar between all three groups. No vaccine-related serious adverse experiences were reported with any of the vaccine formulations. The immune response (percentage of subjects with varicella antibody titers ≥5 gpELISA units) for both refrigerator-stable formulations of VARIVAX at 6 weeks postvaccination was similar to that of the frozen formulation. Administration of either refrigerator-stable formulation of VARIVAX with M-M-RII yielded seroconversion rates and GMTs for measles, mumps and rubella that were comparable to those achieved after administration of the frozen formulation of VARIVAX with M-M-RII.
CONCLUSION
The safety, tolerability, and immunogenicity profile of the refrigerator-stable varicella vaccine was similar to that of the frozen formulation.
目的
VARIVAX®（水痘病毒疫苗，活 Oka/Merck，Merck & Co.，Inc.，新泽西州肯利沃斯）最初获得的是冷冻制剂许可。随后开发了冷藏稳定的 VARIVAX 制剂，以增加世界各地该产品的供应。本研究（V210-051）的目的是证明冷藏稳定的 VARIVAX 制剂的安全性、耐受性和免疫原性与冷冻制剂相似。
方法
在这项双盲、随机、多中心研究中，12-23 个月龄、具有麻疹、腮腺炎、风疹、水痘和带状疱疹阴性接种和临床病史的健康儿童接种了冷藏稳定的 VARIVAX 制剂（两种剂量水平；8000PFU[N=320]或 25000PFU[N=315]）或冷冻制剂的 VARIVAX（10000PFU，N=323），同时接种 M-M-RII®（麻疹、腮腺炎和风疹病毒疫苗活疫苗，Merck & Co.，Inc.，新泽西州肯利沃斯）。接种后 42 天对不良反应进行随访。接种后 6 周评估免疫原性。
结果
冷藏稳定的 VARIVAX 制剂通常具有良好的耐受性。所有三组的不良反应发生率相似。任何疫苗制剂均未报告与疫苗相关的严重不良事件。接种冷藏稳定的 VARIVAX 制剂 6 周后，水痘抗体滴度≥5 gpELISA 单位的受试者比例（%）与冷冻制剂相似。接种冷藏稳定的 VARIVAX 制剂与 M-M-RII 联合接种可产生麻疹、腮腺炎和风疹的血清转化率和 GMTs，与接种 M-M-RII 联合接种冷冻制剂的结果相当。
结论
冷藏稳定的水痘疫苗的安全性、耐受性和免疫原性与冷冻制剂相似。
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