Hepatitis CPhase 1NCT07237282
A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)
A Phase 1 study testing AVIHepC1 and Normal Saline in people with Hepatitis C, run by University of Alberta at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- AVIHepC1 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Jan 2027to 1 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Vanessa Meier-Stephenson, MD, PhD
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Curtis Cooper, MD, MSc
Toronto General Hospital - Toronto Centre for Liver Disease
Toronto, Ontario, M5G 2C4
Jordan Feld, MD, MSc
About this study
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.
Read the 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
- Being tested
- AVIHepC1, Normal Saline
- Keywords
- Vaccine
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVIHepC1Biological
Intramuscular injection administered at 0, 4, and 24 weeks.
Normal SalineBiological
*Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AVIHepC1 | Experimental | Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant. Receives: Biological: AVIHepC1 |
| Normal Saline | Placebo comparator | 0.9% sodium chloride Receives: Biological: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after last dose of vaccine is administered
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months after last dose of vaccine is administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Jan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Meier-Stephenson, MD, PhD, Study chair, University of AlbertaMichael Houghton, PhD, Principal investigator, University of AlbertaLorne Tyrrell, MD, PhD, Principal investigator, University of AlbertaJordan Feld, MD, MSc, Principal investigator, University of TorontoCurtis Cooper, MD, MSc, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237282
- Sponsor's protocol ID
- Pro00147152
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)
- ClinicalTrials.gov ID
- NCT07237282
- Acronym / sponsor ID
- Pro00147152
- Conditions
- Hepatitis C
- Keywords
- Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| AVIHepC1 | Experimental | Biological: AVIHepC1Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant. |
| Normal Saline | Placebo comparator | Biological: Normal Saline0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVIHepC1Intramuscular injection administered at 0, 4, and 24 weeks. | Biological | AVIHepC1 |
| Normal Saline*Only applicable for double-blinded randomized component of the study. Intramuscular injection administered at 0, 4, and 24 weeks. | Biological | Normal Saline |
Primary outcome
Adverse Events
Time frame: 6 months after last dose of vaccine is administered
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.
3 secondary outcomes
Immunogenicity
Time frame: 6 months after last dose of vaccine is administered
Immunogenicity
Time frame: 6 months after last dose of vaccine is administered
Immunogenicity
Time frame: 6 months after last dose of vaccine is administered
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vanessa Meier-Stephenson, MD, PhD study chair
University of Alberta
Michael Houghton, PhD principal investigator
University of Alberta
Lorne Tyrrell, MD, PhD principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AVIHepC1 and Normal Saline in people with Hepatitis C, run by University of Alberta at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Kim, BSc, BA (587-598-2336, hcv@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 6 months after last dose of vaccine is administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.