title: Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations.
abstract: OBJECTIVE
  We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons.
  
  
  METHODS
  Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 10(5) plaque-forming units per dose), RRV-S1 (4 x 10(5) plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol.
  
  
  RESULTS
  During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (-4, 75) for RRV-S1.
  
  
  CONCLUSIONS
  These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.
authors.affiliation: Department of International Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205, USA.
authors.forename: M
authors.initials: M
authors.lastname: Santosham
authors.forename: L H
authors.initials: LH
authors.lastname: Moulton
authors.forename: R
authors.initials: R
authors.lastname: Reid
authors.forename: J
authors.initials: J
authors.lastname: Croll
authors.forename: R
authors.initials: R
authors.lastname: Weatherholt
authors.forename: R
authors.initials: R
authors.lastname: Ward
authors.forename: J
authors.initials: J
authors.lastname: Forro
authors.forename: E
authors.initials: E
authors.lastname: Zito
authors.forename: M
authors.initials: M
authors.lastname: Mack
authors.forename: G
authors.initials: G
authors.lastname: Brenneman
authors.forename: B L
authors.initials: BL
authors.lastname: Davidson
mesh_terms: D004311:Double-Blind Method; D005759:Gastroenteritis / Q000175:diagnosis; D006801:Humans; D007198:Indians, North American; D007223:Infant; D012189:Retrospective Studies; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D012720:Severity of Illness Index; D014613:Vaccines, Attenuated / Q000008:administration & dosage* / Q000009:adverse effects; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D014765:Viral Vaccines; C052014:rhesus rotavirus vaccine