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Oral rhesus/rhesus-human reassortant rotavirus tetravalent vaccine (RRV-TV) was licensed in 1998 but withdrawn in 1999 due to a rare association with intussusception, which occurred disproportionately in infants receiving their first dose at ≥90 days of age.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: George E Armah, Albert Z Kapikian, Timo Vesikari, Nigel Cunliffe, Robert M Jacobson, D Bruce Burlington, Leonard P Ruiz Jr
• Journal: The Journal of infectious diseases (J Infect Dis) Vol. 208 Issue 3 Pg. 423-31 (Aug 01 2013) ISSN: 1537-6613 [Electronic] United States
• PMID: 23599316 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Placebos
• Rotavirus Vaccines
• rhesus rotavirus vaccine

Topics

• Double-Blind Method
• Female
• Gastroenteritis (immunology, prevention & control)
• Ghana
• Humans
• Infant
• Infant, Newborn
• Male
• Placebos (administration & dosage)
• Pregnancy
• Rotavirus Infections (immunology, prevention & control)
• Rotavirus Vaccines (administration & dosage, adverse effects, immunology)
• Vaccination (methods)