Rostad Christina A, Yildirim Inci, Kao Carol, Yi Jumi, Kamidani Satoshi, Peters Etza, Stephens Kathleen, Gibson Theda, Hsiao Hui-Mien, Singh Karnail, Spearman Paul, McCracken Courtney, Agbakoba Vivien, Tomashek Kay M, Goll Johannes B, Gelber Casey E, Johnson Robert A, Lee Sujin, Maner-Smith Kristal, Bosinger Steven, Ortlund Eric A, Chen Xuemin, Anderson Larry J, Wrammert Jens, Suthar Mehul, Rouphael Nadine, Anderson Evan J
Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA.
Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, Atlanta, GA, USA.
NPJ Vaccines. 2024 Dec 23;9(1):255. doi: 10.1038/s41541-024-01042-4.
Filoviruses, including Ebola, Marburg, Sudan, and Taï Forest viruses, are zoonotic pathogens that can cause severe viral hemorrhagic fever and death. Developing vaccines that provide durable, broad immunity against multiple filoviruses is a high global health priority. In this Phase 1 trial, we enrolled 60 healthy U.S. adults and evaluated the safety, reactogenicity and immunogenicity of homologous and heterologous MVA-BN®-Filo and Ad26.ZEBOV prime-boost schedules followed in select arms by MVA-BN®-Filo boost at 1 year (NCT02891980). We found that all vaccine regimens had acceptable safety and reactogenicity. The heterologous prime-boost strategy elicited superior Ebola binding and neutralizing antibody, antibody-dependent cellular cytotoxicity (ADCC), and cellular responses compared to homologous prime-boost. The MVA-BN®-Filo boost administered at 1 year resulted in robust humoral and cellular responses that persisted through 6-month follow-up. Overall, our data demonstrated that a heterologous Ad26.ZEBOV/MVA-BN®-Filo prime-boost was safe and immunogenic and established immunologic memory primed to respond after re-exposure. Clinicaltrials.gov, NCT02891980, registered September 1, 2016.
丝状病毒，包括埃博拉病毒、马尔堡病毒、苏丹病毒和塔伊森林病毒，是可导致严重病毒性出血热和死亡的人畜共患病原体。研发能提供针对多种丝状病毒的持久、广泛免疫力的疫苗是全球卫生领域的一项高度优先事项。在这项1期试验中，我们招募了60名健康的美国成年人，评估了在选定组中采用的同源和异源MVA-BN®-Filo及Ad26.ZEBOV初免-加强接种方案的安全性、反应原性和免疫原性，其中部分组在1年后采用MVA-BN®-Filo加强接种（NCT02891980）。我们发现所有疫苗方案都具有可接受的安全性和反应原性。与同源初免-加强接种相比，异源初免-加强策略引发了更强的埃博拉病毒结合和中和抗体、抗体依赖性细胞毒性（ADCC）以及细胞反应。1年后进行的MVA-BN®-Filo加强接种产生了强大的体液和细胞反应，这些反应在6个月的随访期内持续存在。总体而言，我们的数据表明，异源Ad26.ZEBOV/MVA-BN®-Filo初免-加强接种是安全且具有免疫原性的，并建立了免疫记忆，以便在再次接触后做出反应。Clinicaltrials.gov，NCT02891980，于2016年9月1日注册。
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