Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks. Major concerns are the persistent and disabling polyarthralgia in infected individuals. Here we present the results from a first-in-human trial of the candidate simian adenovirus vectored vaccine ChAdOx1 Chik, expressing the CHIKV full-length structural polyprotein (Capsid, E3, E2, 6k and E1). 24 adult healthy volunteers aged 18–50 years, were recruited in a dose escalation, open-label, nonrandomized and uncontrolled phase 1 trial (registry NCT03590392). Participants received a single intramuscular injection of ChAdOx1 Chik at one of the three preestablished dosages and were followed-up for 6 months. The primary objective was to assess safety and tolerability of ChAdOx1 Chik. The secondary objective was to assess the humoral and cellular immunogenicity. ChAdOx1 Chik was safe at all doses tested with no serious adverse reactions reported. The vast majority of solicited adverse events were mild or moderate, and self-limiting in nature. A single dose induced IgG and T-cell responses against the CHIKV structural antigens. Broadly neutralizing antibodies against the four CHIKV lineages were found in all participants and as early as 2 weeks after vaccination. In summary, ChAdOx1 Chik showed excellent safety, tolerability and 100% PRNT₅₀ seroconversion after a single dose.

基孔肯雅病毒 (CHIKV) 是一种重新出现的蚊媒病毒，可导致迅速爆发。主要问题是受感染个体持续存在且致残的多关节痛。在这里，我们展示了候选猿猴腺病毒载体疫苗 ChAdOx1 Chik 的首次人体试验结果，该疫苗表达 CHIKV 全长结构多蛋白（衣壳、E3、E2、6k 和 E1）。24 名年龄在 18-50 岁之间的成年健康志愿者被招募到一项剂量递增、开放标签、非随机和非对照的 1 期试验（登记处 NCT03590392）中。参与者接受了三种预先设定剂量之一的 ChAdOx1 Chik 单次肌内注射，并接受了 6 个月的随访。主要目的是评估 ChAdOx1 Chik 的安全性和耐受性。次要目的是评估体液和细胞免疫原性。ChAdOx1 Chik 在所有测试剂量下都是安全的，没有报告严重的不良反应。绝大多数征求的不良事件是轻度或中度的，并且具有自限性。单剂量诱导针对 CHIKV 结构抗原的 IgG 和 T 细胞反应。早在接种疫苗 2 周后，所有参与者都发现了针对四种 CHIKV 谱系的广泛中和抗体。总而言之，ChAdOx1 Chik 表现出出色的安全性、耐受性和 100% PRNT 早在接种疫苗 2 周后，所有参与者都发现了针对四种 CHIKV 谱系的广泛中和抗体。总而言之，ChAdOx1 Chik 表现出出色的安全性、耐受性和 100% PRNT 早在接种疫苗 2 周后，所有参与者都发现了针对四种 CHIKV 谱系的广泛中和抗体。总而言之，ChAdOx1 Chik 表现出出色的安全性、耐受性和 100% PRNT单次给药后_{50 次}血清转化。