A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV Vaccine Candidates (HCV Vaccine Trial)
ConditionHepatitis C
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Alberta
About this 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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- AVIHepC1
- Normal Saline
Treatment groups
27 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov