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

NCT07237282 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Pro00147152
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatitis C

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immunogenicity

  6 months after last dose of vaccine is administered

• Immunogenicity

  6 months after last dose of vaccine is administered

• Immunogenicity

  6 months after last dose of vaccine is administered

Study Arms (2)

AVIHepC1

EXPERIMENTAL

Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant.

Biological: AVIHepC1

Normal Saline

PLACEBO COMPARATOR

0.9% sodium chloride

Biological: Normal Saline

Interventions

Normal Saline BIOLOGICAL

\*Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks.

Normal Saline

AVIHepC1 BIOLOGICAL

Intramuscular injection administered at 0, 4, and 24 weeks.

AVIHepC1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand the purpose and the procedures involved in this study and sign the informed consent form;
• Non-pregnant individuals, 18-45 years of age inclusive;
• 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;
• 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;
• 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;
• Agree not to participate in any other clinical trial during the trial;
• Agree not to donate blood for the duration of the trial;
• 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;
• Up to date on recommended seasonal vaccines (influenza and COVID-19) at the time of study enrolment.

You may not qualify if:

• Presence of Hepatitis C antibody (HCV Ab);
• Presence of significant acute infection requiring systemic antibiotic treatment within the 14 days prior to each product administration;
• Pregnant or breast feeding (all individuals physiologically capable of pregnancy will have a negative pregnancy test result prior to each study product administered);
• Past significant reaction following any previous vaccination;
• History of hypersensitivity to any vaccine component;
• Presence of acute infectious disease or fever (e.g., sub-lingual temperature 38.5°C) within the five days prior to study product administration;
• 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;
• Evidence and/or any history of leukaemia, lymphoma, or neoplasm;
• 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 \[budesonide 800 µg per day or fluticasone 750 µg\];
• Received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
• Evidence of bleeding diathesis or any condition that may be associated with a prolonged bleeding time;
• Known inherited genetic anomaly (known as cytogenic disorders) e.g., Down's syndrome;
• 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;
• Clinically significant abnormal laboratory as assessed by the trial physician.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto General Hospital - Toronto Centre for Liver Disease

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vanessa Meier-Stephenson, MD, PhD

  University of Alberta

  STUDY CHAIR

• Michael Houghton, 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Kim, BSc, BA

CONTACT

587-598-2336; hcv@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The first stage will be "open-label" where 3 participants will receive the AVIHepC1 vaccine to assess for safety dosing whereas, the second stage will be double-blinded where the remaining 24 participants will receive either the AVIHepC1 vaccine or a placebo (saline).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial is divided into 2 stages - the 1st stage will be an open-label sentinel safety dosing in 3 participants; if no significant attributable safety concerns after these first 3 participants have received doses 1 and 2 and had their followup; the 2nd stage will be a double-blinded, placebo-controlled, randomized control trial with AVIHepC1 (the newly formulated E1E2 vaccine) compared to saline control in 24 volunteers (12 per trial arm) for a total of 27 participants. Participants will receive doses of the investigational product (AVIHepC1) or placebo (normal saline) at 0, 1 and 6 months. Immediate side effects will be monitored with each visit; phone call and/or electronic check-in with daily diary for the first 8(+/-2) days post each vaccination; and blood draws to check for responses at 4 weeks post each dose and 6 months post the final dose.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

CA (3)