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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AVIHepC1

    Biological/Vaccine

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

  • Normal Saline

    Biological/Vaccine

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

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: AVIHepC1Experimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months after last dose of vaccine is administered

Secondary outcomes

1

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.

Time frame
6 months after last dose of vaccine is administered
2

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.

Time frame
6 months after last dose of vaccine is administered
3

Immunogenicity

T cell responses: T cell responses generated by vaccinees pre- and post-vaccination will be measured by flow cytometry.

Time frame
6 months after last dose of vaccine is administered

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: