Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations☆,☆☆,★,★★
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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Cited by (0)
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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.
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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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