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Efficacy of pentavalent rotavirus vaccine in a high HIV prevalence population in Kenya.
Vaccine. 2012 Apr 27; 30 Suppl 1:A52-60.V

Abstract

BACKGROUND

Rotavirus gastroenteritis (RVGE) is a leading cause of death in African children. The efficacy of pentavalent rotavirus vaccine (PRV) against severe RVGE evaluated in Ghana, Kenya, and Mali in a randomized, double-blind, placebo-controlled trial, showed a combined regional efficacy of 39.3% (95% confidence interval [CI]: 19.1,54.7) in nearly 2 years of follow-up. This report concentrates on the Kenya findings.

METHODS

Infants received 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age. HIV testing was offered to all participants. Data on illness symptoms and signs were collected upon presentation to healthcare facilities, where stools were collected, and analyzed by rotavirus-specific enzyme-linked immunosorbent assay. The primary endpoint was severe RVGE (Vesikari score ≥ 11), occurring ≥ 14 days following the third dose. At monthly home visits, symptoms of illnesses during the past 2 weeks were solicited and limited physical exams were performed; dehydration was defined by WHO's Integrated Management of Childhood Illness.

FINDINGS

Vaccine efficacy (VE) against severe RVGE through nearly 2 years of follow-up among 1308 Kenyan children was 63.9% (95% CI: -5.9,89.8). Through the first year of life, VE against severe RVGE was 83.4% (95% CI: 25.5,98.2). From home visits, VE against all-cause gastroenteritis with severe dehydration was 34.4% (95% CI: 5.3,54.6) through the first year and 29.7% (95% CI: 2.5,49.3) through the entire follow-up period. The reduction in incidence of gastroenteritis with severe dehydration in the community during the first year of life (19.0 cases/100 person-years) was almost six times greater than the reduction in severe RVGE presenting to the clinic (3.3/100 person-years). Oral rehydration solution use was lower among PRV recipients (VE 23.1%, 95% CI: 8.8,35.1). An estimated 41% of gastroenteritis with severe dehydration in the first year reported at home was rotavirus-related.

CONCLUSIONS

PRV significantly reduced severe RVGE in Kenya. The impact of PRV might be greatest in rural Africa in protecting the many children who develop severe gastroenteritis and cannot access health facilities.

Authors+Show Affiliations

Kenya Medical Research Institute/Centers for Disease Control and Prevention, Research and Public Health Collaboration, Kenya. dfeikin@jhsph.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 available

Pub Type(s)

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

Language

eng

PubMed ID

22520137

Citation

Feikin, Daniel R., et al. "Efficacy of Pentavalent Rotavirus Vaccine in a High HIV Prevalence Population in Kenya." Vaccine, vol. 30 Suppl 1, 2012, pp. A52-60.
Feikin DR, Laserson KF, Ojwando J, et al. Efficacy of pentavalent rotavirus vaccine in a high HIV prevalence population in Kenya. Vaccine. 2012;30 Suppl 1:A52-60.
Feikin, D. R., Laserson, K. F., Ojwando, J., Nyambane, G., Ssempijja, V., Audi, A., Nyakundi, D., Oyieko, J., Dallas, M. J., Ciarlet, M., Neuzil, K. M., & Breiman, R. F. (2012). Efficacy of pentavalent rotavirus vaccine in a high HIV prevalence population in Kenya. Vaccine, 30 Suppl 1, A52-60. https://doi.org/10.1016/j.vaccine.2011.08.043
Feikin DR, et al. Efficacy of Pentavalent Rotavirus Vaccine in a High HIV Prevalence Population in Kenya. Vaccine. 2012 Apr 27;30 Suppl 1:A52-60. PubMed PMID: 22520137.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of pentavalent rotavirus vaccine in a high HIV prevalence population in Kenya. AU - Feikin,Daniel R, AU - Laserson,Kayla F, AU - Ojwando,Joel, AU - Nyambane,Geoffrey, AU - Ssempijja,Victor, AU - Audi,Allan, AU - Nyakundi,Daveline, AU - Oyieko,Janet, AU - Dallas,Michael J, AU - Ciarlet,Max, AU - Neuzil,Kathleen M, AU - Breiman,Robert F, PY - 2011/06/17/received PY - 2011/08/02/revised PY - 2011/08/08/accepted PY - 2012/4/24/entrez PY - 2012/5/2/pubmed PY - 2012/8/9/medline SP - A52 EP - 60 JF - Vaccine JO - Vaccine VL - 30 Suppl 1 N2 - BACKGROUND: Rotavirus gastroenteritis (RVGE) is a leading cause of death in African children. The efficacy of pentavalent rotavirus vaccine (PRV) against severe RVGE evaluated in Ghana, Kenya, and Mali in a randomized, double-blind, placebo-controlled trial, showed a combined regional efficacy of 39.3% (95% confidence interval [CI]: 19.1,54.7) in nearly 2 years of follow-up. This report concentrates on the Kenya findings. METHODS: Infants received 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age. HIV testing was offered to all participants. Data on illness symptoms and signs were collected upon presentation to healthcare facilities, where stools were collected, and analyzed by rotavirus-specific enzyme-linked immunosorbent assay. The primary endpoint was severe RVGE (Vesikari score ≥ 11), occurring ≥ 14 days following the third dose. At monthly home visits, symptoms of illnesses during the past 2 weeks were solicited and limited physical exams were performed; dehydration was defined by WHO's Integrated Management of Childhood Illness. FINDINGS: Vaccine efficacy (VE) against severe RVGE through nearly 2 years of follow-up among 1308 Kenyan children was 63.9% (95% CI: -5.9,89.8). Through the first year of life, VE against severe RVGE was 83.4% (95% CI: 25.5,98.2). From home visits, VE against all-cause gastroenteritis with severe dehydration was 34.4% (95% CI: 5.3,54.6) through the first year and 29.7% (95% CI: 2.5,49.3) through the entire follow-up period. The reduction in incidence of gastroenteritis with severe dehydration in the community during the first year of life (19.0 cases/100 person-years) was almost six times greater than the reduction in severe RVGE presenting to the clinic (3.3/100 person-years). Oral rehydration solution use was lower among PRV recipients (VE 23.1%, 95% CI: 8.8,35.1). An estimated 41% of gastroenteritis with severe dehydration in the first year reported at home was rotavirus-related. CONCLUSIONS: PRV significantly reduced severe RVGE in Kenya. The impact of PRV might be greatest in rural Africa in protecting the many children who develop severe gastroenteritis and cannot access health facilities. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22520137/Efficacy_of_pentavalent_rotavirus_vaccine_in_a_high_HIV_prevalence_population_in_Kenya_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01284-9 DB - PRIME DP - Unbound Medicine ER -