title: Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period.
abstract: BACKGROUND
  Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age. This study examined RRV-TV for the prevention of rotavirus gastroenteritis (RV-GE) in Ghana, West Africa, with infants receiving the first dose during the neonatal period and the second before 60 days of age.
  
  
  METHODS
  In a double-blinded, randomized, placebo-controlled trial in Navrongo, Ghana, we recruited neonates to receive 2 doses of RRV-TV or placebo and followed them to age 12 months.
  
  
  RESULTS
  In the intention-to-treat population of 998 infants, we measured a vaccine efficacy of 63.1% against RV-GE of any severity associated with any of the 4 serotypes represented in the vaccine and 60.7% against RV-GE associated with any rotavirus serotype.
  
  
  CONCLUSIONS
  RRV-TV in a 2-dose schedule with the first dose during the neonatal period is efficacious in preventing RV-GE in rural Ghana. Neonatal dosing results in early protection and may be the optimum schedule to avoid or significantly reduce intussusception, now reported to be associated in international settings with the 2 most widely marketed, licensed, live virus, oral rotavirus vaccines.
authors.affiliation: College of Health Sciences, University of Ghana, Legon, Ghana.
authors.forename: George E
authors.initials: GE
authors.lastname: Armah
authors.forename: Albert Z
authors.initials: AZ
authors.lastname: Kapikian
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Nigel
authors.initials: N
authors.lastname: Cunliffe
authors.forename: Robert M
authors.initials: RM
authors.lastname: Jacobson
authors.forename: D Bruce
authors.initials: DB
authors.lastname: Burlington
authors.forename: Leonard P
authors.initials: LP
authors.lastname: Ruiz
mesh_terms: D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control*; D005869:Ghana; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D011247:Pregnancy; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*
chemical_list: D010919:Placebos; D022243:Rotavirus Vaccines; C052014:rhesus rotavirus vaccine
keywords: Ghana; attenuated; diarrhea; gastroenteritis; humans; infant; infantile; randomized controlled trial; rotavirus; rotavirus infections; rotavirus vaccines; vaccines