TY - JOUR
T1 - Efficacy of the oral pentavalent rotavirus vaccine in Mali
AU - Sow, Samba O.
AU - Tapia, Milagritos
AU - Haidara, Fadima C.
AU - Ciarlet, Max
AU - Diallo, Fatoumata
AU - Kodio, Mamoudou
AU - Doumbia, Moussa
AU - Dembélé, Rokiatou D.
AU - Traoré, Oumou
AU - Onwuchekwa, Uma U.
AU - Lewis, Kristen D.C.
AU - Victor, John C.
AU - Steele, A. Duncan
AU - Neuzil, Kathleen M.
AU - Kotloff, Karen L.
AU - Levine, Myron M.
N1 - Funding Information:
This research study was funded by PATH's Rotavirus Vaccine Program under a grant from the GAVI Alliance, and was co-sponsored by Merck & Co., Inc. The study was designed by scientists from Merck & Co., Inc, with substantial input from PATH staff and site investigators. PATH staff independently monitored study execution in Mali and participated in pharmacovigilance and data analyses. We also acknowledge the sincere effort of all our study staffs in Mali at CVD-Mali, Centre National d’Appui à la lute contre la Maladie (CNAM), the Ministry of Health of Mali, the Direction de la Pharmacie et du Medicament (DPM), The CHU-Hopital Gabriel Touré (CHU-HGT), CSCOMs ASACODA, ADASCO, ASACONIA, ANIASCO; traditional healers, religious and socio-cultural leaders; and the support of the community members throughout the study area without which this study would ever have been materialized. Special thank to study personnel at Center for Vaccine Developpment (CVD), University of Maryland: Karen S Ball, and to personnel at CVD-Mali: Kindia Camara.
PY - 2012/4/27
Y1 - 2012/4/27
N2 - 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.
AB - 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.
KW - Efficacy trial
KW - Mali
KW - Rotavirus vaccine
KW - Severe gastroenteritis
UR - http://www.scopus.com/inward/record.url?scp=84859963644&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2011.11.094
DO - 10.1016/j.vaccine.2011.11.094
M3 - Article
C2 - 22520140
AN - SCOPUS:84859963644
SN - 0264-410X
VL - 30
SP - A71-A78
JO - Vaccine
JF - Vaccine
IS - SUPPL. 1
ER -