Ake Julie A, Paolino Kristopher, Hutter Jack N, Cicatelli Susan Biggs, Eller Leigh Anne, Eller Michael A, Costanzo Margaret C, Paquin-Proulx Dominic, Robb Merlin L, Tran Chi L, Anova Lalaine, Jagodzinski Linda L, Ward Lucy A, Kilgore Nicole, Rusnak Janice, Bounds Callie, Badorrek Christopher S, Hooper Jay W, Kwilas Steven A, Ilsbroux Ine, Anumendem Dickson Nkafu, Gaddah Auguste, Shukarev Georgi, Bockstal Viki, Luhn Kerstin, Douoguih Macaya, Robinson Cynthia
U.S. Military HIV Research Program, Center for Infectious Disease Research, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Clinical Trials Center, Center for Enabling Capabilities, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.
Vaccines (Basel). 2024 May 4;12(5):497. doi: 10.3390/vaccines12050497.
The safety and immunogenicity of the two-dose Ebola vaccine regimen MVA-BN-Filo, Ad26.ZEBOV, 14 days apart, was evaluated in people without HIV (PWOH) and living with HIV (PLWH). In this observer-blind, placebo-controlled, phase 2 trial, healthy adults were randomized (4:1) to receive MVA-BN-Filo (dose 1) and Ad26.ZEBOV (dose 2), or two doses of saline/placebo, administered intramuscularly 14 days apart. The primary endpoints were safety (adverse events (AEs)) and immunogenicity (Ebola virus (EBOV) glycoprotein-specific binding antibody responses). Among 75 participants (n = 50 PWOH; n = 25 PLWH), 37% were female, the mean age was 44 years, and 56% were Black/African American. AEs were generally mild/moderate, with no vaccine-related serious AEs. At 21 days post-dose 2, EBOV glycoprotein-specific binding antibody responder rates were 100% among PWOH and 95% among PLWH; geometric mean antibody concentrations were 6286 EU/mL (n = 36) and 2005 EU/mL (n = 19), respectively. A total of 45 neutralizing and other functional antibody responses were frequently observed. Ebola-specific CD4+ and CD8+ T-cell responses were polyfunctional and durable to at least 12 months post-dose 2. The regimen was well tolerated and generated robust, durable immune responses in PWOH and PLWH. Findings support continued evaluation of accelerated vaccine schedules for rapid deployment in populations at immediate risk. Trial registration: NCT02598388 (submitted 14 November 2015).
在未感染艾滋病毒（PWOH）和感染艾滋病毒（PLWH）的人群中，评估了间隔14天接种两剂埃博拉疫苗MVA-BN-Filo和Ad26.ZEBOV的安全性和免疫原性。在这项观察者盲法、安慰剂对照的2期试验中，健康成年人被随机分组（4:1），分别接受MVA-BN-Filo（第1剂）和Ad26.ZEBOV（第2剂），或两剂生理盐水/安慰剂，间隔14天进行肌肉注射。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）。75名参与者（n = 50名PWOH；n = 25名PLWH）中，37%为女性，平均年龄44岁，56%为黑人/非裔美国人。不良事件一般为轻度/中度，无疫苗相关严重不良事件。在第2剂接种后21天，PWOH中EBOV糖蛋白特异性结合抗体应答率为100%，PLWH中为95%；几何平均抗体浓度分别为6286 EU/mL（n = 36）和2005 EU/mL（n = 19）。共频繁观察到45种中和及其他功能性抗体反应。埃博拉特异性CD4+和CD8+ T细胞反应具有多功能性，且在第2剂接种后至少持续12个月。该方案耐受性良好，在PWOH和PLWH中均产生了强烈、持久的免疫反应。研究结果支持继续评估加速疫苗接种方案，以便在面临直接风险的人群中快速部署。试验注册号：NCT02598388（2015年11月14日提交）
