( rent markets for bothtravelers in deve...)Avant's Typhoid Fever Vaccine Demonstrates Excellent Clinical,Potential,Health

The Phase 1/2 study was an in-patient dose-escalating clinical trial aimed at determining the safety and immunogenicity of the single-dose, oral Ty800 vaccine. The trial evaluated three escalating dose levels of the vaccine in 47 healthy adult volunteers and followed each volunteer for six months post-vaccination. The clinical trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), and was conducted at the Cincinnati Children's Hospital Medical Center. This clinical trial has been funded in whole or in part with Federal funds from the NIAID of the NIH, Department of Health and Human Services, under contract No. NO AI 25459.

About the Ty800 Vaccine

AVANT has designed the Ty800 vaccine to offer rapid, oral, single-dose protection against Salmonella typhi, the cause of typhoid fever. The Ty800 vaccine was developed using genetic techniques to delete specific genes known to be essential to the virulence of S. typhi. The clinical trial was designed to show whether Ty800 would be well tolerated in humans and rapidly elicit strong immune responses.

The Study

A total of 47 healthy volunteers participated in the Ty800 study. Thirty-three subjects were randomly sorted into three different dose groups having mean doses administered of 8x10(7), 6x10(8) and 1x10(10) colony-forming units (CFUs) and 14 received a placebo consisting of buffer only. The dose of 6x10(8) CFU in this study appeared to be immunogenic with similar reactogenicity as placebo. In addition, over 90% of vaccinees showed positive immune responses for both systemic (IgG) and mucosal (IgA) antibodies to typhoid based on an ELISPOT assay. Results of the study are being presented today at a vaccines meeting in Baltimore, MD entitled "Progress and Opportunities in the Prevention of Enteric Disea
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