Merck & Co., Inc., Kenilworth, New Jersey.
Crozet BioPharma, Devens, Massachusetts.
Am J Trop Med Hyg. 2019 Jul;101(1):207-213. doi: 10.4269/ajtmh.19-0076.
rVSVΔG-ZEBOV-GP vaccine is a live recombinant (r) vesicular stomatitis virus (VSV), where the VSV G protein is replaced with the Zaire Ebola virus (ZEBOV) glycoprotein (GP). For vaccine immunogenicity testing, clinical trial sera collected during an active ZEBOV outbreak underwent gamma irradiation (GI) before testing in biosafety level 2 laboratories to inactivate possible wild-type ZEBOV. Before irradiating pivotal trial samples, two independent studies evaluated the impact of GI (50 kGy) on binding ZEBOV-GP (ELISA) antibodies against rVSVΔG-ZEBOV-GP, using sera from a North American phase 1 study. Gamma irradiation was associated with slightly higher antibody concentrations in pre-vaccination samples and slightly lower concentrations postvaccination. Results indicate that GI is a viable method for treating samples from regions where filoviruses are endemic, with minor effects on antibody titers. The impact of GI on immunogenicity analyses should be considered when interpreting data from irradiated specimens.
rVSVΔG-ZEBOV-GP 疫苗是一种活重组（r）水疱性口炎病毒（VSV），其中 VSV G 蛋白被替换为扎伊尔埃博拉病毒（ZEBOV）糖蛋白（GP）。为了进行疫苗免疫原性测试，在生物安全 2 级实验室中进行测试之前，对主动 ZEBOV 爆发期间收集的临床试验血清进行伽马辐照（GI），以灭活可能的野生型 ZEBOV。在辐照关键试验样本之前，两项独立的研究使用来自北美 1 期研究的血清评估了 GI（50 kGy）对结合 rVSVΔG-ZEBOV-GP（ELISA）抗体的影响。伽马辐照与接种前样本中的抗体浓度略有升高和接种后浓度略有降低有关。结果表明，GI 是处理来自流行丝状病毒的地区的样本的可行方法，对抗体滴度的影响很小。在解释辐照标本的数据时，应考虑 GI 对免疫原性分析的影响。
