title: Effect of human rotavirus vaccine on severe diarrhea in African infants.
abstract: BACKGROUND
  Rotavirus is the most common cause of severe gastroenteritis among young children worldwide. Data are needed to assess the efficacy of the rotavirus vaccine in African children.
  
  
  METHODS
  We conducted a randomized, placebo-controlled, multicenter trial in South Africa (3166 infants; 64.1% of the total) and Malawi (1773 infants; 35.9% of the total) to evaluate the efficacy of a live, oral rotavirus vaccine in preventing severe rotavirus gastroenteritis. Healthy infants were randomly assigned in a 1:1:1 ratio to receive two doses of vaccine (in addition to one dose of placebo) or three doses of vaccine--the pooled vaccine group--or three doses of placebo at 6, 10, and 14 weeks of age. Episodes of gastroenteritis caused by wild-type rotavirus during the first year of life were assessed through active follow-up surveillance and were graded with the use of the Vesikari scale.
  
  
  RESULTS
  A total of 4939 infants were enrolled and randomly assigned to one of the three groups; 1647 infants received two doses of the vaccine, 1651 infants received three doses of the vaccine, and 1641 received placebo. Of the 4417 infants included in the per-protocol efficacy analysis, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group and in 1.9% of those in the pooled vaccine group (vaccine efficacy, 61.2%; 95% confidence interval, 44.0 to 73.2). Vaccine efficacy was lower in Malawi than in South Africa (49.4% vs. 76.9%); however, the number of episodes of severe rotavirus gastroenteritis that were prevented was greater in Malawi than in South Africa (6.7 vs. 4.2 cases prevented per 100 infants vaccinated per year). Efficacy against all-cause severe gastroenteritis was 30.2%. At least one serious adverse event was reported in 9.7% of the infants in the pooled vaccine group and in 11.5% of the infants in the placebo group.
  
  
  CONCLUSIONS
  Human rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis among African infants during the first year of life. (ClinicalTrials.gov number, NCT00241644.)
authors.affiliation: Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.forename: Nigel A
authors.initials: NA
authors.lastname: Cunliffe
authors.forename: Duncan
authors.initials: D
authors.lastname: Steele
authors.forename: Desirée
authors.initials: D
authors.lastname: Witte
authors.forename: Mari
authors.initials: M
authors.lastname: Kirsten
authors.forename: Cheryl
authors.initials: C
authors.lastname: Louw
authors.forename: Bagrey
authors.initials: B
authors.lastname: Ngwira
authors.forename: John C
authors.initials: JC
authors.lastname: Victor
authors.forename: Paul H
authors.initials: PH
authors.lastname: Gillard
authors.forename: Brigitte B
authors.initials: BB
authors.lastname: Cheuvart
authors.forename: Htay H
authors.initials: HH
authors.lastname: Han
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Neuzil
mesh_terms: D000914:Antibodies, Viral / Q000097:blood; D003968:Diarrhea, Infantile / Q000453:epidemiology / Q000517:prevention & control*; D005243:Feces / Q000821:virology; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D015658:HIV Infections / Q000175:diagnosis; D006801:Humans; D015994:Incidence; D007223:Infant; D008295:Malawi / Q000453:epidemiology; D008297:Male; D012401:Rotavirus / Q000145:classification / Q000276:immunology / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D013019:South Africa / Q000453:epidemiology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated