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Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa.
Vaccine. 2012 Apr 27; 30 Suppl 1:A79-85.V

Abstract

The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.

Authors+Show Affiliations

Centre pour le Développement des Vaccins, Bamako, Mali. mtapia@medicine.umaryland.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22520141

Citation

Tapia, Milagritos D., et al. "Secondary Efficacy Endpoints of the Pentavalent Rotavirus Vaccine Against Gastroenteritis in sub-Saharan Africa." Vaccine, vol. 30 Suppl 1, 2012, pp. A79-85.
Tapia MD, Armah G, Breiman RF, et al. Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. Vaccine. 2012;30 Suppl 1:A79-85.
Tapia, M. D., Armah, G., Breiman, R. F., Dallas, M. J., Lewis, K. D., Sow, S. O., Rivers, S. B., Levine, M. M., Laserson, K. F., Feikin, D. R., Victor, J. C., Ciarlet, M., Neuzil, K. M., & Steele, A. D. (2012). Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. Vaccine, 30 Suppl 1, A79-85. https://doi.org/10.1016/j.vaccine.2012.01.022
Tapia MD, et al. Secondary Efficacy Endpoints of the Pentavalent Rotavirus Vaccine Against Gastroenteritis in sub-Saharan Africa. Vaccine. 2012 Apr 27;30 Suppl 1:A79-85. PubMed PMID: 22520141.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Secondary efficacy endpoints of the pentavalent rotavirus vaccine against gastroenteritis in sub-Saharan Africa. AU - Tapia,Milagritos D, AU - Armah,George, AU - Breiman,Robert F, AU - Dallas,Michael J, AU - Lewis,Kristen D C, AU - Sow,Samba O, AU - Rivers,Stephen B, AU - Levine,Myron M, AU - Laserson,Kayla F, AU - Feikin,Daniel R, AU - Victor,John C, AU - Ciarlet,Max, AU - Neuzil,Kathleen M, AU - Steele,A Duncan, PY - 2011/08/12/received PY - 2011/12/19/revised PY - 2012/01/06/accepted PY - 2012/4/24/entrez PY - 2012/5/2/pubmed PY - 2012/8/9/medline SP - A79 EP - 85 JF - Vaccine JO - Vaccine VL - 30 Suppl 1 N2 - The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22520141/Secondary_efficacy_endpoints_of_the_pentavalent_rotavirus_vaccine_against_gastroenteritis_in_sub_Saharan_Africa_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00037-0 DB - PRIME DP - Unbound Medicine ER -