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 groups

Locations

3
University of Alberta HospitalT6G 2B7, EdmontonAlberta, Canada
Ottawa Hospital - General CampusK1H 8L6, OttawaOntario, Canada
Toronto General Hospital - Toronto Centre for Liver DiseaseM5G 2C4, TorontoOntario, Canada

Sponsors and collaborators

University of Alberta

Lead sponsor