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

George E. Armah, Albert Z. Kapikian, Timo Vesikari, Nigel Cunliffe, Robert M. Jacobson, D. Bruce Burlington, Leonard P. Ruiz

Research output: Contribution to journalArticle

32 Citations (Scopus)

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 Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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.

Original languageEnglish (US)
Pages (from-to)423-431
Number of pages9
JournalJournal of Infectious Diseases
Volume208
Issue number3
DOIs
StatePublished - Aug 1 2013

Fingerprint

Rotavirus Vaccines
Ghana
Rotavirus
Gastroenteritis
Safety
Intussusception
Appointments and Schedules
Vaccines
Placebos
Western Africa
Randomized Controlled Trials
Newborn Infant
Viruses
Population

Keywords

  • attenuated
  • diarrhea
  • gastroenteritis
  • Ghana
  • humans
  • infant
  • infantile
  • randomized controlled trial
  • rotavirus
  • rotavirus infections
  • rotavirus vaccines
  • vaccines

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Cite this

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. / Armah, George E.; Kapikian, Albert Z.; Vesikari, Timo; Cunliffe, Nigel; Jacobson, Robert M.; Burlington, D. Bruce; Ruiz, Leonard P.

In: Journal of Infectious Diseases, Vol. 208, No. 3, 01.08.2013, p. 423-431.

Research output: Contribution to journalArticle

Armah, George E. ; Kapikian, Albert Z. ; Vesikari, Timo ; Cunliffe, Nigel ; Jacobson, Robert M. ; Burlington, D. Bruce ; Ruiz, Leonard P. / 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. In: Journal of Infectious Diseases. 2013 ; Vol. 208, No. 3. pp. 423-431.
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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.",
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