NCT07237282

A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and antibody (germ fighters) response of the experimental (investigational) vaccine against HCV when injected into the arm of healthy adults.

Detailed description

The Hepatitis C Virus (HCV) continues to be a significant public health threat, infecting 58 million people worldwide and over 250,000 Canadians. The virus disproportionately affects marginalized populations. It is a bloodborne virus that affects the liver and is most commonly spread through unsafe injection practices, sexual practices that lead to blood exposures, and unsafe health care (i.e., transfusion of contaminated blood and blood products). If left untreated, these infections progress to chronic hepatitis, liver cirrhosis (liver failure) and potentially hepatocellular carcinoma (liver cancer) or death. Current treatments for HCV include expensive drug combinations that can cure HCV in most but do not prevent reinfection if there is another exposure. At this time, there are no vaccines available to prevent HCV and the diseases that it causes.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	AVIHepC1	Intramuscular injection administered at 0, 4, and 24 weeks.
BIOLOGICAL	Normal Saline	\*Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-01-01
• Completion: 2027-07-01
• First posted: 2025-11-19
• Last updated: 2026-02-06

Locations

3 sites across 1 country: Canada