Not Yet RecruitingPhase 1

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

Canada27 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

Adverse Events

Timeframe: 6 months after last dose of vaccine is administered

Trial details

NCT IDNCT07237282

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Kelly Kim, BSc, BA

587-598-2336 hcv@ualberta.ca

View on ClinicalTrials.gov More Hepatitis C trials