title: Efficacy of pentavalent rotavirus vaccine in a high HIV prevalence population in Kenya.
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.
  
  
  RESULTS
  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.affiliation: Kenya Medical Research Institute/Centers for Disease Control and Prevention, Research and Public Health Collaboration, Kenya. dfeikin@jhsph.edu
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Feikin
authors.forename: Kayla F
authors.initials: KF
authors.lastname: Laserson
authors.forename: Joel
authors.initials: J
authors.lastname: Ojwando
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Nyambane
authors.forename: Victor
authors.initials: V
authors.lastname: Ssempijja
authors.forename: Allan
authors.initials: A
authors.lastname: Audi
authors.forename: Daveline
authors.initials: D
authors.lastname: Nyakundi
authors.forename: Janet
authors.initials: J
authors.lastname: Oyieko
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Dallas
authors.forename: Max
authors.initials: M
authors.lastname: Ciarlet
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Neuzil
authors.forename: Robert F
authors.initials: RF
authors.lastname: Breiman
mesh_terms: D000284:Administration, Oral; D004311:Double-Blind Method; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D005838:Genotype; D015658:HIV Infections / Q000150:complications / Q000276:immunology; D006801:Humans; D015994:Incidence; D007223:Infant; D007630:Kenya / Q000453:epidemiology; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D012401:Rotavirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000453:epidemiology / Q000473:pathology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology
chemical_list: D010919:Placebos; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated