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

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • AVIHepC1 — BIOLOGICAL
    Intramuscular 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: AVIHepC1
    Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant.
  • Placebo Comparator: Normal Saline
    0.9% sodium chloride

Primary Outcome Measure

Adverse Events [ Time Frame: 6 months after last dose of vaccine is administered ]

Central Contacts

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