FDAnews
www.fdanews.com/articles/105425-avant-vaccine-meets-endpoints-in-trial

Avant Vaccine Meets Endpoints in Trial

April 1, 2008

Avant Immunotherapeutics’ Phase II trial of its typhoid fever vaccine Ty800 has met all primary endpoints.

The double-blind, placebo-controlled, multicenter study was an outpatient, dose-ranging trial in 183 healthy volunteers that evaluated two dose levels of the vaccine and followed each subject for six months post-vaccination. The endpoints of the study were to determine the optimal dose of Ty800 for further development.

Data from the trial showed that the vaccine was well tolerated and the desired immune response was achieved, Avant said. Incidence of reactogenicity symptoms and adverse events post-vaccination were similar to placebo, and positive immune response rates were observed in 65.5 percent and 80 percent of patients in the low and high dose groups, respectively.

Avant said it is advancing its pipeline toward creating a “super combination traveler’s vaccine” to protect against multiple bacterial diseases, including cholera, typhoid, enterotoxigenic E. coli and paratyphoid.