Clinical results with AVANT rotavirus vaccine demonstrate nearly 90% protection in young children

NEEDHAM, MA (July 22, 1999): AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today the publication of the detailed results of a Phase II clinical study of AVANT's investigational rotavirus vaccine in the British medical journal, Lancet. The results of the Phase II efficacy trial suggests that the two-dose oral rotavirus vaccine should be helpful in the prevention of rotavirus disease in young children. The clinical investigators reported that the vaccine provided those treated with nearly 90% protection from disease.

David Bernstein, M.D., the lead investigator at the Cincinnati Children's Hospital Medical Center, in association with his colleagues at The Johns Hopkins University Medical School in Baltimore, and the Pittsburgh Pediatric Research and Pennridge Pediatric Associates in Philadelphia, examined the effectiveness of the AVANT vaccine in infants.

The authors write, "The efficacy of the two-dose 89-12 vaccine reported in this study, 89% against any rotavirus illness, is the highest reported for any multicenter study. This compares to efficacy for the currently approved three-dose vaccine that ranged from 49% to 68%." They also write, "The 89-12 rotavirus vaccine was safe, immunogenic, and provided a high level of protection against rotavirus disease."

Dr. Bernstein commented, "We were very pleased with the high level of protection provided by AVANT's vaccine. The excellent safety and efficacy data reported in this publication, along with the inherent advantages of this vaccine, indicate that further development of this highly effective rotavirus vaccine is warranted."

The double-blind, placebo-controlled Phase II study involved a total of 215 infants, of ages nine to 16 weeks. Infants received two oral doses of vaccine or placebo and were followed by active surveillance through one rotavirus season. In the reported study, rotavirus disease occurred in only two patients in the vaccine group compared to 18 patients in th

Contact: Joan Kureczka
Kureczka/Martin Associates

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