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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Biological: AVIHepC1; Biological: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kelly Kim, BSc, BA; Phone Number: 587-598-2336; Email: hcv@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University Of Alberta Hospital
      • Contact: Vanessa Meier-Stephenson, MD, PhD
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital - General Campus
      • Contact: Curtis Cooper, MD, MSc
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital - Toronto Centre for Liver Disease
      • Contact: Jordan Feld, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able to understand the purpose and the procedures involved in this study and sign the informed consent form;
2. Non-pregnant individuals, 18-45 years of age inclusive;
3. Individuals must agree not to become pregnant during the trial. If they are capable of pregnancy and sexually active, they must use an effective method of birth control;
4. Non-smoker and in good general health, as determined by medical screening evaluation, performed by PI, or delegated sub-investigator no greater than 4 weeks (28 days) before the first dose in the form of medical history, clinical laboratory tests and physical examination;
5. Agrees to reside in the geographical area for next 12 months and not intending to travel outside of Canada for at least 14 days following each study vaccine administration;
6. Agree not to participate in any other clinical trial during the trial;
7. Agree not to donate blood for the duration of the trial;
8. Agree to restrain from intensive physical exercise i.e., exercise that varies significantly from an everyday exercise routine, 3 days before and after (± 3 days) administration of each dose, including each interim visit for blood sample collection;
9. Up to date on recommended seasonal vaccines (influenza and COVID-19) at the time of study enrolment.

Exclusion Criteria:

1. Presence of Hepatitis C antibody (HCV Ab);
2. Presence of significant acute infection requiring systemic antibiotic treatment within the 14 days prior to each product administration;
3. Pregnant or breast feeding (all individuals physiologically capable of pregnancy will have a negative pregnancy test result prior to each study product administered);
4. Past significant reaction following any previous vaccination;
5. History of hypersensitivity to any vaccine component;
6. Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5°C) within the five days prior to study product administration;
7. Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immunodeficiencies), insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, psoriasis, rheumatoid arthritis, asthma, epilepsy or obsessive-compulsive disorder, skin carcinoma excluding non-spreadable skin cancers such as basal cell and squamous cell carcinoma;
8. Evidence and/or any history of leukaemia, lymphoma, or neoplasm;
9. Presence or suspicion of impaired immune system function. Currently receiving or having within the past three years received immunosuppressive therapy, including systemic steroids, ACTH or inhaled steroids in dosages that are associated with hypothalamic-pituitary-adrenal axis suppression, such as 1mg/kg/day of prednisone or its equivalent or chronic use of inhaled high potency corticosteroids [budesonide 800 µg per day or fluticasone 750 µg];
10. Received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
11. Evidence of bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
12. Known inherited genetic anomaly (known as cytogenic disorders) e.g., Down's syndrome;
13. Evidence of any condition that, in the opinion of the clinical investigator, might interfere with the evaluation of the study objectives or pose excessive risks to participants;
14. Clinically significant abnormal laboratory as assessed by the trial physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline; 0.9% sodium chloride	Biological: Normal Saline; *Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks.
Experimental: AVIHepC1; Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant.	Biological: AVIHepC1; Intramuscular injection administered at 0, 4, and 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Safety is the primary outcome. Clinical symptoms and signs, standard laboratory parameters (hematological and biochemical), and ancillary data will be collected and assessed for safety monitoring throughout the study which will also be reviewed by the Data Safety Monitoring Board (DSMB) accordingly.	6 months after last dose of vaccine is administered

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity	Antibody titres: Samples of sera and PBMCs will be collected from the participants prior to each injection and at the scheduled clinic visits. The titre of vaccine specific antibodies will be determined using ELISA. The presence of vaccine-specific antibodies in all participants in the study will be monitored.	6 months after last dose of vaccine is administered
Immunogenicity	Assessment for pan-genotypic neutralizing antibodies in vitro: Sera will be tested for neutralization capacity via a panel of infectious cell-culture-propagated HCV genotypes.	6 months after last dose of vaccine is administered
Immunogenicity	T cell responses: T cell responses generated by vaccinees pre- and post-vaccination will be measured by flow cytometry.	6 months after last dose of vaccine is administered

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Michael Houghton, PhD, University of Alberta; Study Chair: Vanessa Meier-Stephenson, MD, PhD, University of Alberta; Principal Investigator: Lorne Tyrrell, MD, PhD, University of Alberta; Principal Investigator: Jordan Feld, MD, MSc, University of Toronto; Principal Investigator: Curtis Cooper, MD, MSc, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Vaccine
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Flaviviridae Infections; Hepatitis; Hepatitis C; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: Pro00147152

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No