Hepatitis C virus infection is spread through the blood, and it can lead to liver cirrhosis and is the leading cause of liver cancer. Okairos, a spinout from Merck ($MRK), is starting a Phase I/II clinical trial for its preventive hep C vaccine for people at risk of infection that it says is the first multi-center, double-blinded, randomized, placebo-controlled trial of a vaccine to prevent HCV infection.
The trial will involve 350 people and will measure safety, as well as the number of people who develop chronic HCV infection. The company's HCV vaccine uses chimpanzee-derived adenovirus vectors to stimulate a robust T cell response, rather than an antibody response against selected antigens.
The vaccine is part of a collaboration between Okairos and the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health (NIH). NIH is funding the Phase I/II trial, which follows a successful Phase I trial in which the vaccine triggered an immune response in healthy volunteers.
"This could change the landscape quite a bit," said Les Funtleyder, a healthcare strategist and portfolio manager at Miller Tabak & Co. in New York, according to Bloomberg. "In theory, if you could vaccinate everyone, you'd need a lot less drug."
Okairos has had a good start--since spinning out from Merck, it has received backing from BioMedInvest, Boehringer Ingelheim Venture Fund, LSP, Novartis Venture Funds and Versant Ventures. Its vaccine technology also has potential in respiratory syncytial virus and influenza. A number of biotech companies are focusing on therapeutic HCV vaccines, but Okairos Chief Operating Officer Tom Woiwode, PhD, told FierceVaccines the company sees preventing the disease as an area of unmet need. There is currently no HCV preventive vaccine on the market, he added. The company is seeking partners for the vaccine, according to Bloomberg.