Safety and immunogenicity of a delayed booster dose of the rVSVΔG-ZEBOV-GP vaccine for prevention of Ebola virus disease: a multicentre, open-label, phase 2 randomised controlled trial

作者：Richard T. Davey, Gary Collins, Nadine Rouphael, Guillaume Poliquin, Rosemary McConnell, Gabrielle Grubbs, Susan Moir, Joanne M. Langley, Marc Teitelbaum, Angela Hewlett, Susan McLellan, Nahid Bhadelia, Vanessa Raabe, Mark J. Mulligan, Irina Maljkovic Berry, Bonnie Dighero-Kemp, Jonathan Kurtz, Lisa E. Hensley, Nelson Dozier, Lindsay Marron, Alain DuChêne, Jens H. Kuhn, Shawn Brown, Surender Khurana, H. Clifford Lane, James D. Neaton · 发表于：The Lancet Microbe · 年份：2024 · DOI：10.1016/s2666-5247(24)00163-0 · 被引用次数：9 · 研究领域：Viral Infections and Outbreaks Research、SARS-CoV-2 and COVID-19 Research、Vaccine Coverage and Hesitancy

BACKGROUND: rVSVΔG-ZEBOV-GP is the first approved vaccine with clinical efficacy against Ebola virus disease. Although a seroprotective threshold has not been defined for those at occupational risk of exposure, the current vaccine strategy is to attain a sustained high level of antibody titres. The aim of this trial was to explore the effects of delayed boosting upon both the height and duration of antibody titres following primary immunisation. METHODS: plaque-forming unit per mL of VSVΔG-ZEBOV-GP. 18 months later, individuals who consented and were still eligible were randomly assigned 1:1 to receive either a homologous booster dose or no booster. Study visits for safety and serial blood collections for antibody titres were done on enrolled participants at months 0, 1, 3, 6, 12, 18, 19, 24, 30, and 36. Through July, 2021, a web-based application was used for randomisation, including assignments with schedules for each of the five sites using mixed permuted blocks. The trial was not masked to participants or site staff. The primary endpoint was a comparison of geometric mean titres (GMTs) of anti-Ebola virus glycoprotein IgG antibody at month 36 (ie, 18 months after randomisation) for all randomly assigned participants who completed the 36 months of follow-up (primary analysis cohort). Investigators were aware of antibody titres from baseline (enrolment) through month 18 but were masked to summary data by randomisation group after month 18. This study is registered with Clin...