PEDIATRICS Vol. 97 No. 1 January 1996, pp. 7-13
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Safety and Efficacy of High-dose Rhesus-Human Reassortant Rotavirus Vaccines—Report of the National Multicenter Trial

Margaret B. Rennels MD1, Roger I. Glass MD, PhD2, Penelope H. Dennehy MD3, David I. Bernstein MD4, Michael E. Pichichero MD5, Edward T. Zito PhD6, Michael E. Mack PhD6, Bruce L. Davidson MD, MPH7, Albert Z. Kapikian MD8, and United States Rotavirus Vaccine Efficacy Group

1 Center for Vaccine Development and Department of Pediatrics, University of Maryland School of Medicine, Baltimore
2 Viral Gastroenteritis Section, Respiratory and Enteric Viruses Branch, Division of Viral and Rickettsial Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia
3 Division of Pediatric Infectious Disease, Rhode Island Hospital, Providence
4 J. N. Gamble Institute of Medical Research, Cincinnati, Ohio
5 Department of Pediatrics, University of Rochester Medical Center, Rochester, New York
6 Wyeth-Ayerst Research, Philadelphia
7 Wyeth-Ayerst Research, Philadelphia; Division of Pulmonary and Critical Care Medicine, Medical College of Pennsylvania and Hahnemann University, Philadelphia
8 Laboratory of infectious Diseases, National Institutes of Health, Bethesda, Maryland

Objective. Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs).

Design. In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2,4, and 6 months of age. Vaccines contained 4 x 105 plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus.

Results. The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea.

Conclusion. RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.

Submitted on July 17, 1995
Accepted on September 12, 1995




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