Date: 2012-03-14
Type of information:
phase: 1-2
Announcement: initiation of the trial
Company: Okairos (Switzerland)
Product: HCV vaccine
Action
mechanism: Okairos’ HCV vaccine is based on a technology platform that uses proprietary, chimpanzee-derived adenovirus vectors to stimulate a robust T-cell response against selected antigens. Okairos’ research has shown that it is able to stimulate robust T-cell responses that provide strong protection in preclinical non-human primate challenge models.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On March 14, 2012, Okairos has announced the initiation of a Phase I/II clinical trial evaluating its vaccine against the hepatitis C virus (HCV). This is the first multi-center, double blinded, randomized, placebo-controlled trial of a vaccine to prevent HCV infection, and represents a major milestone in the collaboration between Okairos and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH). The NIH-funded trial will be conducted by co-principal investigators from Johns Hopkins University and the University of California San Francisco (UCSF).The trial follows promising Phase I results that were recently published in Science Translational Medicine, showing that the vaccine had a good safety profile, was well tolerated, and that it stimulated a highly potent T-cell response in healthy volunteers. This Phase I/II trial will provide the opportunity to demonstrate the potential effectiveness of such an approach in protecting against chronic HCV infection, the leading cause of liver cancer.The trial will enroll 350 subjects and will begin with an interim Phase I analysis of safety and immunogenicity data in a subset of them. The primary endpoints of the overall study will measure the incidence of chronic HCV infection, as well as the safety and tolerability of the vaccine.
