Second-Year Follow-up Evaluation of Live, Attenuated Human Rotavirus Vaccine 89-12 in Healthy Infants

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http://www.journals.uchicago.edu/JID/journal/issues/v186n10/020621/brief/020621.abstract.html

The Journal of Infectious Diseases    2002;186:1487-1489
© 2002 by the Infectious Diseases Society of America. All rights reserved.
0022-1899/2002/18610-0015$15.00

 

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CONCISE COMMUNICATION

Second-Year Follow-up Evaluation of Live, Attenuated Human Rotavirus Vaccine 89-12 in Healthy Infants

David I. Bernstein,1 David A. Sack,2 Keith Reisinger,3 Edward Rothstein,4 and Richard L. Ward1

1Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; 2Johns Hopkins University, Baltimore, Maryland; 3Primary Physicians Research, Pittsburgh, and 4Pennridge Pediatric Associates, Sellersville, and Temple University School of Medicine, Philadelphia, Pennsylvania

Received 30 May 2002; revised 17 July 2002; electronically published 22 October 2002.

Rotavirus vaccine development is a high priority. The association between the tetravalent rhesus-human reassortant rotavirus vaccine and intussusception has increased the need to develop new vaccines. In a small efficacy trial, the human rotavirus vaccine 89-12 recently has been shown to be safe and effective; 184 of the 215 healthy infants initially enrolled in this trial were followed for a second year. Vaccine efficacy during the second year was 59% (P = .047). For the 2 years of observation, vaccine efficacy was 76% against rotavirus gastroenteritis, 83% against severe rotavirus gastroenteritis, and 100% against rotavirus illnesses requiring medical intervention (P < .001 for each). These encouraging results have led to continued evaluation, in several countries, of a vaccine candidate derived from strain 89-12.

 

     Presented in part: Infectious Diseases Society of America meeting, New Orleans, 7–10 September 2000.
     Informed consent was obtained from the parents or guardians of participating children. Human experimentation guidelines of the US Department of Health and Human Services and/or those of the authors' institutions were followed in the conduct this research.
     Financial support: Avant Therapeutics; SmithKline Biologicals (now Glaxo SmithKline).
     Commercial and other associations: D.I.B. and R.L.W. are inventors of human rotavirus vaccine 89-12 (patent "Human Rotaviruses, Vaccines and Methods" [issued 12 December 1995]) and were consultants to Avant Therapeutics and SmithKline Biologicals.

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