Background Shorter prophylactic vaccine schedules may offer more rapid protection against Ebola in resource-limited settings. Methods This randomized, observer-blind, placebo-controlled, phase 2 trial conducted in five sub-Saharan African countries included people without HIV (PWOH, n = 249) and people living with HIV (PLWH, n = 250). Adult participants received one of two accelerated Ebola vaccine regimens (MVA-BN-Filo, Ad26.ZEBOV administered 14 days apart [n = 79] or Ad26.ZEBOV, MVA-BN-Filo administered 28 days apart [n = 322]) or saline/placebo (n = 98). The primary endpoints were safety (adverse events [AEs]) and immunogenicity (Ebola virus [EBOV] glycoprotein-specific binding antibody responses). Binding antibody responders were defined as participants with a > 2.5-fold increase from baseline or the lower limit of quantification if negative at baseline. Results The mean age was 33.4 years, 52% of participants were female, and among PLWH, the median (interquartile range) CD4+ cell count was 560.0 (418.0-752.0) cells/μL. AEs were generally mild/moderate with no vaccine-related serious AEs or remarkable safety profile differences by HIV status. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody response rates in vaccine recipients were 99% for the 14-day regimen (geometric mean concentrations [GMCs]: 5168 enzyme-linked immunosorbent assay units (EU)/mL in PWOH; 2509 EU/mL in PLWH), and 98% for the 28-day regimen (GMCs: 6037 EU/mL in PWOH; 2939 EU/mL in PLWH). At 12 months post-dose 2, GMCs in PWOH and PLWH were 635 and 514 EU/mL, respectively, for the 14-day regimen and 331 and 360 EU/mL, respectively, for the 28-day regimen. Conclusions Accelerated 14- and 28-day Ebola vaccine regimens were safe and immunogenic in PWOH and PLWH in Africa. Trial registration NCT02598388

中文翻译：

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非洲艾滋病毒感染者和未感染者的加速异源两剂埃博拉疫苗方案的安全性和免疫原性

背景 在资源有限的环境中，较短的预防性疫苗接种计划可能会提供更快速的埃博拉保护。方法 这项随机、观察者盲法、安慰剂对照 2 期试验在五个撒哈拉以南非洲国家进行，受试者包括未感染艾滋病毒的人 (PWOH，n = 249) 和艾滋病毒感染者 (PLWH，n = 250)。成人参与者接受两种加速埃博拉疫苗方案之一（MVA-BN-Filo、Ad26.ZEBOV 给药间隔 14 天 [n = 79] 或 Ad26.ZEBOV、MVA-BN-Filo 给药间隔 28 天 [n = 322]）或盐水/安慰剂 (n = 98)。主要终点是安全性（不良事件 [AE]）和免疫原性（埃博拉病毒 [EBOV] 糖蛋白特异性结合抗体反应）。结合抗体应答者被定义为具有≥1的参与者。如果基线为阴性，则相对于基线或定量下限增加 2.5 倍。结果 平均年龄为 33.4 岁，52% 的参与者为女性，PLWH 中 CD4+ 细胞计数中位数（四分位数范围）为 560.0 (418.0-752.0) 个细胞/μL。 AE 通常为轻度/中度，没有与疫苗相关的严重 AE，也没有因 HIV 状态而存在显着的安全性差异。第 2 次给药后 21 天，疫苗接种者中 14 天方案的 EBOV 糖蛋白特异性结合抗体应答率为 99%（几何平均浓度 [GMC]：PWOH 中 5168 酶联免疫吸附测定单位 (EU)/mL ；PLWH 中为 2509 EU/mL），28 天治疗方案为 98%（GMC：PWOH 中为 6037 EU/mL；PLWH 中为 2939 EU/mL）。第 2 次给药后 12 个月时，14 天治疗方案的 PWOH 和 PLWH 中的 GMC 分别为 635 EU/mL 和 514 EU/mL，28 天治疗方案的 GMC 分别为 331 和 360 EU/mL。结论 14 天和 28 天加速埃博拉疫苗方案对于非洲的感染者康复者和艾滋病感染者来说是安全的且具有免疫原性。试用注册NCT02598388