Efficacy of the oral pentavalent rotavirus vaccine in Mali.

摘要: The oral, pentavalent rotavirus vaccine (PRV), RotaTeq was assessed for prevention of severe gastroenteritis (RVGE) in young children two multi-site, randomized, placebo-controlled field trials; one Asia (Vietnam and Bangladesh) the other sub-Saharan Africa (Ghana, Kenya Mali). efficacy results Mali site multi-country trial are presented here. We randomly assigned infants a 1:1 ratio to receive 3 doses PRV/placebo at approximately 6, 10, 14 weeks age. Gastroenteritis episodes were captured passively local health centers by home visits. primary study outcome RVGE, as defined score ≥ 11 using Vesikari Clinical Scoring System occurring days after third dose until end study. Other analyses included against RVGE through first year during second years life, well receiving least vaccine. In total, 1960 enrolled sera collected on subset (approximately 150) immunogenicity testing. follow-up, largely due cultural practices visit traditional healers point care, estimate unreliable: per protocol 1% (95% confidence interval [CI]: -431.7, 81.6); intention-to-treat 42.9% CI: -125.7, 87.7). During surveillance system modified adapt customs care seeking practices, per-protocol 19.2% -23.1,47.3%). 82.5% Malian 70.1,91.3%) who received PRV mounted seroresponse (≥ 3-fold rise from baseline (prevaccination) post-dose vaccination) anti-rotavirus immunoglobulin A antibody, with post third-dose geometric mean titer (GMT) 31.3 units/mL. By contrast, only 20.0% placebo recipients 10.0, 33.7%) developed post-third GMT 3.2 None serious clinical adverse events observed considered be vaccine-related.