Avant commences Phase II trial of typhoid fever vaccine

The Phase II study is an out-patient, dose-ranging clinical trial that will evaluate two dose levels of the single-dose, oral Ty800 vaccine and will follow each subject for six months post-vaccination.

The objectives of the study are to determine the optimal dose of Ty800 for further development based on the safety, reactogenicity, and immunogenicity of the vaccine. The study is being conducted by Accelovance at five clinical sites across the US.

“We see the commencement of this trial as serving the dual role of addressing a significant health issue in the developing world and advancing development of Avant’s bacterial vaccine franchise,” commented Una Ryan, president and CEO of Avant Immunotherapeutics.

The company is advancing its programs towards creating a “super combination traveler’s vaccine”, designed to capture the potential of its single-dose oral delivery platforms to combine protection against multiple bacterial diseases including cholera, typhoid, ETEC (enterotoxigenic E. coli) and paratyphoid into one convenient and efficient vaccine for world travelers.

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 is designed to show that Ty800 is well tolerated in humans and rapidly elicits strong immune responses.