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Evaluation of Rhesus Rotavirus Monovalent and Tetravalent Reassortant Vaccines in US Children
David I. Bernstein, MD;
Roger I. Glass, MD, PhD;
George Rodgers, MD, PhD;
Bruce L. Davidson, MD, MPH;
David A. Sack, MD;
US Rotavirus Vaccine Efficacy Group;
E. Anderson, MD;
D. Bernstein, MD;
R. Ward, PhD;
S. Chartrand, MD;
J. Cherry, MD;
D. Blumberg, MD;
B. Davidson, MD;
E. Zito, PhD;
M. Mack, PhD;
J. Forro, PhD;
J. Camardo, MD;
E. Starr, MS;
P. Dennehy, MD;
S. Fries, MD;
H. Froehlich, MD;
R. Glass, MD, PhD;
C. Hamm, MD;
R. Imrie, MD;
M. Jackson, MD;
K. Kim, MD;
E. Guzman, MD;
M. Levin, MD;
Y. Maldonado, MD;
M. Pichichero, MD;
L. Pickering, MD;
A. Pomeranz, MD;
M. Rennels, MD;
V. Keane, MD;
G. Rodgers, MD, PhD;
G. Rabalais, MD;
D. Sack, MD;
D. Said, MD;
N. Singh-Naz, MD;
F. Pedreira, MD;
R. van Dyke, MD;
E. Wald, MD
JAMA. 1995;273(15):1191-1196.
Abstract
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Objective.
—To determine the safety and relative efficacy of two reassortant rhesus rotavirus vaccines over two rotavirus seasons.
Design.
—A prospective, double-masked, placebo-controlled trial.
Setting.
—Twenty-three centers in the United States.
Participants.
—A total of 1006 healthy infants between 4 and 26 weeks of age were enrolled, and 898 received three doses of vaccine or placebo.
Main Outcome Measures.
—Reactogenicity was determined by comparing the incidence of fever, diarrhea, and/or vomiting for 5 days after each dose of vaccine. Rotavirus IgA and neutralizing antibody to rhesus rotavirus and four rotavirus serotypes were measured in a subset of subjects. Relative efficacy was determined by comparing the incidence of rotavirus gastroenteritis after three doses of vaccine or placebo over two rotavirus seasons.
Results.
—Adverse reactions were mild and limited to a small but significant increase in the incidence of fever after the first dose of tetravalent but not monovalent vaccine. The relative efficacy against rotavirus disease over the 2 years of observation was 40% (98.3% confidence interval, 7% to 62%) for the monovalent and 57% (98.3% confidence interval, 29% to 74%) for the tetravalent vaccine. In post hoc analyses, the relative efficacy against very severe rotavirus gastroenteritis was 73% and 82% for monovalent and tetravalent vaccine recipients, respectively. Also, a 67% and 78% reduction in medical visits for rotavirus gastroenteritis was observed. Both vaccines protected against disease caused by serotype 1 rotavirus, but only the tetravalent vaccine reduced the incidence of disease caused by non— serotype 1 rotavirus infection detected in the second season. It is unclear, however, whether this result represents serotype-specific protection or a difference in the duration of protection.
Conclusions.
—Vaccination with both vaccines was safe and significantly reduced the incidence of rotavirus gastroenteritis, but only the tetravalent vaccine provided protection against disease caused by non—serotype 1 rotaviruses during the second year of follow-up.
(JAMA. 1995;273:1191-1196)
Author Affiliations
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University of St Louis (Mo); J. N. Gamble Institute of Medical Research, Cincinnati, Ohio; Creighton University, Omaha, Neb; University of California Medical Center, Los Angeles; Wyeth-Ayerst, Philadelphia, Pa; Rhode Island Hospital, Providence; Boulder (Colo) Medical Center; Fresno (Calif) Research Center; Centers for Disease Control and Prevention, Atlanta, Ga; St Vincent's Hospital, Indianapolis, Ind; Cleveland (Ohio) Clinic; Children's Mercy Hospital, Kansas City, Mo; Los Angeles (Calif) Children's Hospital; University of Colorado, Denver; Stanford University, Palo Alto, Calif; Elmwood Pediatric Group, Rochester, NY; University of Texas Medical School, Houston; Downtown Health Center, Milwaukee, Wis; University of Maryland, Baltimore; University of Louisville (Ky); The Johns Hopkins University, Baltimore, Md; Children's Hospital National Medical Center, Washington, DC; Tulane University, New Orleans, La; Children's Hospital, Pittsburgh, Pa.
From the Division of Clinical Virology, J. N. Gamble Institute of Medical Research, Cincinnati, Ohio (Dr Bernstein); Viral Gastroenteritis Unit, Centers for Disease Control and Prevention, Atlanta, Ga (Dr Glass); Department of Pediatrics, University of Louisville (Ky) School of Medicine (Dr Rodgers); Wyeth-Ayerst, Philadelphia, Pa (Dr Davidson); and Department of International Health, The Johns Hopkins University, Baltimore, Md (Dr Sack). Dr Davidson is now with the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Medical College of Pennsylvania, and Hahnemann University. Philadelphia.
Footnotes
Dr Bernstein was paid $3000 by Wyeth-Ayerst for his role in analyzing the data and writing the manuscript. Dr Davidson was employed by and owned stock in Wyeth-Ayerst while the study and analysis were being conducted.
A complete list of the participants in this research study appears at the end of this article.
Reprint requests to J. N. Gamble Institute of Medical Research, 2141 Auburn Ave, Cincinnati, OH 45219 (Dr Bernstein).
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