The recent spread of Zika virus (ZIKV) through the Americas and Caribbean and its devastating consequences for pregnant women and their babies have driven the search for a safe and efficacious ZIKV vaccine. Among the vaccine candidates, a first-generation ZIKV purified inactivated vaccine (ZPIV), adjuvanted with aluminum hydroxide, developed by the Walter Reed Army Institute of Research (WRAIR), has elicited high seroconversion rates in participants in three phase-I clinical trials. In collaboration with the WRAIR, Sanofi Pasteur (SP) optimized the production scale, culture and purification conditions, and increased the regulatory compliance, both of which are critical for clinical development and licensure of this vaccine. Using a clinical batch of the first-generation ZPIV as a benchmark, we report that different doses of the optimized vaccine (ZPIV-SP) elicited sustained neutralizing antibodies, specific T- and memory B-cells, and provided complete protection against a ZIKV challenge in cynomolgus macaques. These data provide evidence that the ZPIV-SP vaccine performs at least as well as the ZPIV vaccine, and provide support for continued development in the event of future ZIKV outbreaks.

最近寨卡病毒 (ZIKV) 在美洲和加勒比地区的传播及其对孕妇及其婴儿的破坏性后果促使人们寻找安全有效的寨卡病毒疫苗。在候选疫苗中，由沃尔特里德陆军研究所 (WRAIR) 开发的第一代 ZIKV 纯化灭活疫苗 (ZPIV) 以氢氧化铝为佐剂，在三个 I 期临床试验的参与者中引起了高血清转化率。赛诺菲巴斯德 (SP) 与 WRAIR 合作，优化了生产规模、培养和纯化条件，并提高了合规性，这两者对于该疫苗的临床开发和许可至关重要。以第一代ZPIV的一个临床批次为基准，我们报告说，不同剂量的优化疫苗 (ZPIV-SP) 引发了持续的中和抗体、特异性 T 细胞和记忆 B 细胞，并为食蟹猴提供了针对 ZIKV 攻击的完全保护。这些数据证明 ZPIV-SP 疫苗的性能至少与 ZPIV 疫苗一样好，并为未来 ZIKV 爆发时的持续开发提供支持。