The safety and immunogenicity of a candidate therapeutic T cell, MVA-based hepatitis C vaccine: Assessed in a Phase 1 clinical trial

Hepatitis C infects 0.8% of Canadians, one third of whom are likely to develop cirrhosis, which may lead to liver failure and/or liver cancer. Current antiviral therapies are effective in only half of those who are able to tolerate the therapy. New treatments are needed. Most affected individuals develop persistent infection and ongoing liver inflammation (hepatitis) because their immune system responds only weakly to the virus. This weak response is sufficient to give rise to inflammation of the liver but is insufficient to clear the virus from the infected liver cells. A two-stage study is planned - the first to establish baseline measurements of immune response to hepatitis C, both in individuals with a chronic hepatitis and in those who have been able to clear the virus on their own. The second stage is to use these same tests to evaluate a vaccine, which has components of the hepatitis C virus incorporated into a highly attenuated small pox virus proven to be safe in human (methodology now new), given to individuals with chronic hepatitis C, the aim being to stimulate the immune system in these individuals sufficiently to promote viral clearance.