Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations.

Abstract

OBJECTIVES:

We compared the efficacy, safety, and immunogenicity of a rhesus rotavirus tetravalent vaccine (RRV-TV), a rhesus rotavirus monovalent (serotype 1) vaccine (RRV-S1), and placebo in healthy American Indian infants for two rotavirus seasons.

STUDY DESIGN:

Infants aged 6 to 24 weeks were enrolled in a randomized, double-blind efficacy study. Infants were orally administered RRV-TV (4 x 10(5) plaque-forming units per dose), RRV-S1 (4 x 10(5) plaque-forming units per dose), or placebo at 2, 4, and 6 months of age. Stools collected during episodes of gastroenteritis were tested for detection of rotavirus antigen. A total of 1185 infants received at least one dose of a study vaccine or placebo, and 1051 received all three doses according to the protocol.

RESULTS:

During the first year of surveillance, the estimates of vaccine efficacy (with 95% confidence interval) for preventing rotaviral gastroenteritis were 50% (26, 67) for RRV-TV and 29% (-1, 50) for RRV-S1. In this population only 6% of rotaviral gastroenteritis episodes among placebo recipients were associated with type G1 disease. For severe disease the estimates of vaccine efficacy were higher: 69% (29, 88) for RRV-TV and 48% (-4, 75) for RRV-S1.

CONCLUSIONS:

These data indicate that RRV-TV is moderately efficacious in preventing all episodes of gastroenteritis caused by rotavirus and is most efficacious against the severe disease characteristic of rotaviral illness.

• Authors: M Santosham, L H Moulton, R Reid, J Croll, R Weatherholt, R Ward, J Forro, E Zito, M Mack, G Brenneman, B L Davidson
• Journal: The Journal of pediatrics (J Pediatr) Vol. 131 Issue 4 Pg. 632-8 (Oct 1997) ISSN: 0022-3476 [Print] United States
• PMID: 9386673 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Rotavirus Vaccines
• Vaccines, Attenuated
• Viral Vaccines
• rhesus rotavirus vaccine

Topics

• Double-Blind Method
• Gastroenteritis (diagnosis)
• Humans
• Indians, North American
• Infant
• Retrospective Studies
• Rotavirus Infections (immunology, prevention & control)
• Rotavirus Vaccines
• Severity of Illness Index
• Vaccines, Attenuated (administration & dosage, adverse effects)
• Viral Vaccines (administration & dosage, adverse effects)