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J Infect Dis. 2013 Aug 1;208(3):423-31. doi: 10.1093/infdis/jit174. Epub 2013 Apr 18.

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.

Author information

1
College of Health Sciences, University of Ghana, Legon, Ghana.

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Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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

KEYWORDS:

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

PMID:
23599316
PMCID:
PMC3699001
DOI:
10.1093/infdis/jit174
[Indexed for MEDLINE]
Free PMC Article

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