1. The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSVΔG-ZEBOV-GP Vaccine Tolerability and Safety during the West Africa Ebola Outbreak
- Author
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Samai, M, Seward, JF, Goldstein, ST, Mahon, BE, Lisk, DR, Widdowson, MA, Jalloh, MI, Schrag, SJ, Idriss, A, Carter, RJ, Dawson, P, Kargbo, SAS, Leigh, B, Bawoh, M, Legardy-Williams, J, Deen, G, Carr, W, Callis, A, Lindblad, R, Russell, JBW, Petrie, CR, Fombah, AE, Kargbo, B, McDonald, W, Jarrett, Olamide, Walker, RE, Gargiullo, P, Bash-Taqi, D, Gibson, L, Fofanah, AB, Schuchat, A, Neuzil, K, Insip, H, Risi, G, and Sow, S
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Uncategorized - Abstract
The West Africa Ebola epidemic stimulated rapid implementation of Ebola vaccine trials in the 3 highly affected countries. In Sierra Leone, we studied the recombinant vesicular stomatitis virus Ebola vaccine (rVSVΔG-ZEBOV-GP) safety and efficacy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) was a randomized, unblinded Phase 2/3 trial with phased vaccine introduction, no placebo, and concurrent evaluation of vaccine safety and efficacy. Healthcare and frontline response workers in 5 districts were randomized to immediate or deferred (18-24 weeks later) vaccination and followed for 6 months postvaccination. We enrolled 8651 participants from April through August 2015; 7998 were vaccinated. No participants developed Ebola virus disease so an efficacy assessment was not possible. Overall, 132 (1.5%) participants experienced serious adverse events (SAEs); none were vaccine-related. In a detailed safety substudy (N = 436), vaccinated participants reported significantly more systemic adverse events (AEs) within 7 days than unvaccinated participants including fever higher than 38°C (20.5% vs 3.9%), headache (71.2% vs 22.1%), fatigue (50.7% vs 10.4%), and joint pain (31.7% vs 6.5%); most AEs were mild to moderate severity and resolved within 5 days. During days 5-28, vaccinated participants more commonly reported joint pain (17.0% vs 4.8%) and rash (7.8% vs 1.7%) (P
- Published
- 2021
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