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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Efficacy of the oral pentavalent rotavirus vaccine in Mali
Vaccine, Volume 30, No. SUPPL. 1, Year 2012
Notification
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Description
The oral, pentavalent rotavirus vaccine (PRV), RotaTeq was assessed for prevention of severe rotavirus gastroenteritis (RVGE) in young children in two multi-site, randomized, placebo-controlled field trials; one in Asia (Vietnam and Bangladesh) and the other in sub-Saharan Africa (Ghana, Kenya and Mali). The efficacy results for the Mali site of the multi-country trial are presented here. We randomly assigned infants in a 1:1 ratio to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age. Gastroenteritis episodes were captured passively at the local health centers and by home visits. The primary study outcome was severe RVGE, as defined by a score of ≥11 using the Vesikari Clinical Scoring System occurring ≥14 days after the third dose until the end of the study. Other efficacy analyses included efficacy against severe RVGE through the first year and during the second years of life, as well as efficacy after receiving at least one dose of vaccine. In total, 1960 infants were enrolled in the trial at the Mali site and sera were collected on a subset of infants (approximately 150) for immunogenicity testing. In the first year of follow-up, largely due to cultural practices to visit traditional healers as the first point of care, the point estimate of efficacy was unreliable: the per protocol vaccine efficacy against severe RVGE was 1% (95% confidence interval [CI]: -431.7, 81.6); the intention-to-treat vaccine efficacy was 42.9% (95% CI: -125.7, 87.7). During the second year of follow-up, after the surveillance system was modified to adapt to local customs and health care seeking practices, the point estimate of per-protocol vaccine efficacy was 19.2% (95% CI: -23.1,47.3%). 82.5% of Malian infants (95% CI: 70.1,91.3%) who received PRV mounted a seroresponse (≥3-fold rise from baseline (prevaccination) to post-dose 3 vaccination) of anti-rotavirus immunoglobulin A antibody, with a post third-dose geometric mean titer (GMT) of 31.3. units/mL. By contrast, only 20.0% of placebo recipients (95% CI: 10.0, 33.7%) developed a seroresponse and the post-third dose GMT was 3.2. units/mL. None of the serious clinical adverse events observed were considered to be vaccine-related. © 2011 Elsevier Ltd.
Authors & Co-Authors
Sow, Samba Ousmane
Unknown Affiliation
Tapia, Milagritos D.
Unknown Affiliation
Haidara, Fadima Cheick
Unknown Affiliation
Ciarlet, Max
Unknown Affiliation
Diallo, Fatoumata Binta Tidiane
Unknown Affiliation
Kodio, Mamoudou
Unknown Affiliation
Doumbia, Moussa F.
Unknown Affiliation
Dembélé, Rokiatou D.
Unknown Affiliation
Traoré, Oumou
Unknown Affiliation
Onwuchekwa, Uma U.
Unknown Affiliation
Lewis, Kristen D.C.
Unknown Affiliation
Victor, John C.
Unknown Affiliation
Steele, Andrew Duncan
Unknown Affiliation
Neuzil, Kathleen Maletic
Unknown Affiliation
Kotloff, Karen L.
Unknown Affiliation
Levine, Myron M.
Unknown Affiliation
Statistics
Citations: 59
Authors: 16
Affiliations: 6
Identifiers
Doi:
10.1016/j.vaccine.2011.11.094
ISSN:
0264410X
e-ISSN:
18732518
Research Areas
Health System And Policy
Maternal And Child Health
Study Design
Cohort Study
Study Locations
Ghana
Kenya
Mali