Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE).
Year of Publication
Fombah, Augustin E; Goldstein, Susan T; Jarrett, Olamide D; Jalloh, Mohamed I; El-Khorazaty, Jill; Lisk, Durodami Radcliffe; Legardy-Williams, Jennifer; Pratt, Dudley A; George, Peter M; Russell, James B W; Schrag, Stephanie J; Dawson, Peter; Deen, Gibrilla F; Carr, Wendy; Lindblad, Robert; James, Faustine; Bah, Mohamed M; Yillia, John F; Sandy, Jibao D; Turay, Patrick E; Conteh, Muhammad-Abbas; Slutsker, Laurence; Mahon, Barbara E; Samai, Mohamed; Seward, Jane F
J Infect Dis
disease burden; Ebola; Ebola vaccine; health conditions; recombinant vesicular stomatitis; Sierra Leone; STRIVE; vaccine
The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a clinical trial of the investigational recombinant vesicular stomatitis virus–based Ebola virus vaccine (rVSV∆ZEBOV-GP; Merck), provided an opportunity to assess health conditions in a cohort of healthy Sierra Leonean adults before vaccination. Of the 8793 healthcare and frontline Ebola response workers screened for study enrollment, 7 (0.1%) self-reported human immunodeficiency virus infection or another significant immunodeficiency disorder and 11 of 3190 (0.3%) women 18–49 years old had a positive urine pregnancy test. Of the 440 participants included in a safety substudy, 124 (28.2%) reported at least 1 medical condition at baseline, most commonly drug hypersensitivity (11.6%), arthralgia (3.9%), arthropathy (2.7%), or gastric (3.0%) or peptic (2.7%) ulcer disease. We calculated the incidence per 100 person-years (PY) and 95% confidence intervals (CIs) of new medical conditions among the 4297 participants followed for 18–24 weeks from enrollment to scheduled vaccination. The most commonly reported conditions were headache (32.4 PY [95% CI, 29.7–35.3 PY]), pain (unspecified) (17.3 PY [95% CI, 15.4–19.4 PY]), arthralgia (9.3 PY [95% CI, 7.9–10.8 PY]), and abdominal pain (9.1 PY [95% CI, 7.7–10.7 PY]). Nasopharyngitis (7.0 PY [95% CI, 5.8–8.4 PY]) and malaria (1.9 PY [95% CI, 1.3–2.7 PY]) were the most commonly reported infectious conditions. Several cases of hypertension, diabetes mellitus, and cancer were also reported.