Grant: Operating Grant: Clinical Trials Projects

Chronic hepatitis C virus (HCV) continues to be a significant public health problem, infecting 58 million people worldwide and over 250,000 Canadians. The WHO has targeted the eradication of HCV infection as a major public health threat by 2030 to be accomplished by first diagnosing HCV carriers, then curing them with HCV antiviral therapy, and secondly by developing a long sought-after prophylactic HCV vaccine. The Li Ka Shing Applied Virology Institute (under the leadership of Dr Michael Houghton) has designed an adjuvanted protein-based HCV vaccine in preparation for phase 1 clinical testing to begin in 2024. In initial study phase, we will be determining the optimal dose of the adjuvanted vaccine to determine what amount to proceed to the second phase. We will enroll three groups of 20 healthy volunteers to receive either placebo, or different doses of the protein-based vaccines in a randomized, blinded manner. The volunteers' blood will be checked for immune response to the different vaccine doses and closely monitored for any side effects or signs of safety concerns. The clinicians overseeing the trial will meet regularly to review any potential safety concerns and the Data Safety and Monitoring Board will meet at the completion of the first phase (assuming no other concerns warranting meeting sooner) and will decide whether the components are safe to proceed to the second phase. If the trial vaccine is deemed safe and efficacious, one further step in the path toward HCV elimination will be gained.