A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)
- Sponsor
- University of Alberta
- Study ID
- NCT07237282
- Phase
- PHASE1
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- AVIHepC1 — BIOLOGICALIntramuscular injection administered at 0, 4, and 24 weeks.
- Normal Saline — BIOLOGICAL\*Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks.
Study Details
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.
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- May 2026
- Primary completion
- Jan 1, 2027
- Completion
- Jul 1, 2027
Study Design
- Enrollment
- 27 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: AVIHepC1Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant.
- Placebo Comparator: Normal Saline0.9% sodium chloride
Primary Outcome Measure
Adverse Events [ Time Frame: 6 months after last dose of vaccine is administered ]
Central Contacts
- Kelly Kim, BSc, BA587-598-2336
Related Studies
- Evaluation of Patients With Liver DiseaseRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
- The 1200 Patients Project: Studying the Implementation of Clinical Pharmacogenomic TestingRecruiting · University of Chicago · Chicago, Illinois
- Proteogenomic Monitoring and Assessment of Liver Transplant RecipientsRecruiting · Northwestern University · Chicago, Illinois
- The HOPE Study: Characterizing Patients With Hepatitis B and CRecruiting · University of Maryland, Baltimore · Baltimore, Maryland