HCV Vaccine for Hepatitis C

Not yet recruiting at 2 trial locations

Overseen By Kelly Kim, BSc, BA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alberta

Must not be taking: Systemic steroids, Immunosuppressive therapy

Disqualifiers: HCV antibody, Serious chronic diseases, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, AVIHepC1, designed to protect against Hepatitis C. Researchers aim to determine if the vaccine is safe and can trigger a strong immune response in healthy adults. Participants will receive either the vaccine or a placebo (a harmless saltwater solution) to compare results. This trial suits healthy, non-smoking adults living in Canada who do not have Hepatitis C or other significant health conditions. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding how it works in people.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the AVIHepC1 vaccine for Hepatitis C is currently undergoing testing to ensure safety. As this trial is in an early stage, the main goal is to assess how well participants tolerate the vaccine. Researchers closely monitor for any side effects or reactions.

Previous studies on Hepatitis C vaccines have found that many are generally well-tolerated. Common side effects include soreness at the injection site, mild fever, or tiredness. Serious side effects are rare, but the study team closely monitors participants to ensure their safety.

Since this vaccine is still in early testing, detailed safety information specific to AVIHepC1 may not yet be fully available. However, testing in humans suggests that earlier tests, possibly in labs or animals, indicated it might be safe enough for human trials. Participants in this trial provide crucial information to confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for Hepatitis C, which typically involves antiviral medications like sofosbuvir and ledipasvir, the AVIHepC1 vaccine offers a proactive approach to preventing the disease. This vaccine is unique because it uses a GMP-Grade E1E2 heterodimer envelope protein combined with a GMP-Grade SLA-SE adjuvant. Researchers are excited about AVIHepC1 as it targets the virus differently by potentially stimulating the immune system to recognize and fight off Hepatitis C before infection can occur. This could be a game-changer, offering a preventive measure rather than treating the disease after infection.

What evidence suggests that this vaccine might be an effective treatment for Hepatitis C?

Research shows that most recipients of the AVIHepC1 vaccine, which participants in this trial may receive, produced antibodies that fight off germs like the Hepatitis C virus (HCV). However, it remains unclear if the vaccine can fully prevent long-term HCV infection, as results have been mixed. Some studies found that although vaccinated individuals had a strong immune response, the vaccine did not always prevent the virus from persisting in the body. Overall, this vaccine appears promising in building a defense against the virus, but it is still too early to determine its effectiveness in completely preventing HCV. ^{1 2 6 7 8}

Who Is on the Research Team?

Vanessa Meier-Stephenson, MD, PhD

Principal Investigator

University of Alberta

Michael Houghton, PhD

Principal Investigator

University of Alberta

Lorne Tyrrell, MD, PhD

Principal Investigator

University of Alberta

Jordan Feld, MD, MSc

Principal Investigator

University of Toronto

Curtis Cooper, MD, MSc

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test new Hepatitis C vaccines. Specific eligibility details are not provided, but typically participants should have no history of HCV infection and be willing to comply with the study requirements.

Inclusion Criteria

I understand this study's purpose and procedures and can sign the consent form.

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

I am between 18 and 45 years old and not pregnant.

Exclusion Criteria

I have a condition that could cause prolonged bleeding.

I have a genetic condition like 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational HCV vaccine or placebo

6 months

Multiple visits for vaccine administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AVIHepC1

Trial Overview The trial is testing two interventions: AVIHepC1, which is an experimental vaccine against Hepatitis C, and Normal Saline as a control. Participants will receive injections into their arm to assess safety and antibody response.

How Is the Trial Designed?

Group I: AVIHepC1 Experimental Treatment 1 Intervention

Contains two components: (1) GMP-Grade E1E2 heterodimer envelope protein (4.5µg); and (2) GMP-Grade SLA-SE adjuvant.

Group II: Normal Saline Placebo Group 1 Intervention

0.9% sodium chloride

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07237282

A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV ... The purpose of this study is to investigate the safety and antibody (germ fighters) response of the experimental (investigational) vaccine ...

2. trial.medpath.com trial.medpath.com/clinical-trial/ae26bdf233a2da47/nct07237282-protein-hcv-vaccine-candidates

A Phase 1 Clinical Trial of Adjuvanted Protein-based HCV ... The purpose of this study is to investigate the safety and antibody (germ fighters) response of the experimental (investigational) vaccine against HCV when ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39205311/

Update on Hepatitis C Vaccine: Results and Challenges Therapy against the Hepatitis C virus (HCV) has significantly improved with the introduction of direct-acting antiviral drugs (DAAs), ...

4. natap.org natap.org/2019/IDWeek/IDWeek_86.htm

Results of the First Prophylactic Hepatitis C Virus Vaccine ... Specifically, the vaccine efficacy in preventing chronic infection was -0.53 (95% confidence interval [CI], -2.5 to 0.34). Of vaccinated subjects, 78% generated ...

5. mdpi.com mdpi.com/1999-4915/16/8/1337

Update on Hepatitis C Vaccine: Results and Challenges Therapy against the Hepatitis C virus (HCV) has significantly improved with the introduction of direct-acting antiviral drugs (DAAs), achieving over 95% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9992130/

Phase I Trial of a Therapeutic DNA Vaccine for Preventing ... We studied the safety and immunogenicity of a novel therapeutic hepatitis C virus (HCV) genotype 1a/1b consensus DNA vaccine, INO-8000, encoding HCV NS3, NS4A, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01436357

NCT01436357 | Staged Phase I/II Hepatitis C Prophylactic ... A planned interim analysis of safety and immunogenicity will be conducted based on data through 1 week after receipt of the second vaccination. If no safety ...

8. virologyj.biomedcentral.com virologyj.biomedcentral.com/articles/10.1186/s12985-021-01716-8

Hepatitis C virus DNA vaccines: a systematic review The objective of this study is to provide a systematic review of HCV DNA vaccines and investigate and discuss the strategies employed to optimize their ...