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

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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 × 105 plaque-forming units per dose), RRV-S1 (4 × 105 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. (J Pediatr 1997;131:632-8)

Section snippets

Methods

The study was conducted from Jan. 1, 1992, to Jan. 31, 1994. The study population consisted of infants residing on the Gila River Indian Reservation (Arizona), the Navajo Indian Reservation (Arizona and New Mexico), the San Carlos Apache Indian Reservation (Arizona), and the Fort Apache Indian Reservation (Arizona). The study protocol was approved by the Johns Hopkins University Committee on Human Research, the Indian Health Service, and the Tribal Councils and Health Boards of the respective

Results

A first dose of vaccine or placebo was given to 1185 infants (396 RRV-TV, 398 RRV-S1, and 391 placebo). Three doses of the vaccine or placebo were given to 1059 infants. Of these, eight infants received vaccine or placebo outside the protocol-defined time intervals and were excluded from primary efficacy analyses. Among the 1185 infants who received at least one dose of the vaccine, 1084 (91%) completed year 1 of surveillance, and the parents/guardians of 1027 (95%) of the infants who completed

Discussion

The results of this study confirm the findings of two other multicenter studies conducted in the general U.S. population to evaluate the safety and efficacy of RRV-TV and RRV-S1. 8, 9 Both the RRV-TV and the RRV-S1 vaccines were well tolerated by the American Indian infants. The rates of adverse reactions observed by us were similar to those seen in the two previous U.S. studies. 8, 9 The point estimate of efficacy seen in this study for RRV-TV against all RV disease in year 1 was the same as

Acknowledgements

We would like to thank the Health Boards of White Mountain Apache Tribe (AZ), Gila River Indian Reservation (AZ), and San Carlos Apache Tribe (AZ); The Health Boards of Chinle (AZ), Fort Defiance (AZ), Gallup (NM), and Shiprock (NM) on The Navajo Indian Reservation; The Navajo Nation Health Research Review Board, The Phoenix Area Indian Health Service Institutional Review Board, The National Indian Health Service Institutional Review Board, and The Johns Hopkins University Committee on Human

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    The opinions expressed by the authors are not necessarily those of the Indian Health Service.

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    Supported by a grant from Wyeth-Ayerst Research.

    Reprint requests: Mathuram Santosham, MD, Center for American Indian and Alaskan Native Health, Department of International Health, Johns Hopkins University School of Hygiene and Public Health, 615 N. Wolfe St., Baltimore, MD 21205.

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