The trial will enroll 15 chronically infected patients who have never received any therapy for their condition. The trial’s primary endpoint is safety and secondary endpoints are immunological response to the vaccination and effect on viral load.
Availability of safety data is planned by year end 2007 and virological and immunological response parameters by the third quarter of 2008.
TG4040, which expresses non structural proteins of the hepatitis C virus, aims at inducing a strong and broad immune response against the infected cells.
TG4040 shares the same MVA-vector technology as Transgene’s other infectious-disease therapeutic vaccine TG4001 which has been shown to be effective in a phase II trial for the treatment of patients with high-grade cervical intraepithelial neoplasia caused by human papilloma virus infection.