DNA Vaccine for Chronic Hepatitis C

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: HIV, Autoimmune disorders, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

33 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using systemic corticosteroids, you must stop them at least 4 weeks before joining the study, and inhaled corticosteroids must be stopped at least 48 hours before joining.

What data supports the effectiveness of the treatment Electroporation-Mediated Plasmid DNA Vaccine Therapy, HCV DNA Vaccine INO-8000 for chronic hepatitis C?

Research shows that the INO-8000 vaccine, when used with electroporation (a method to enhance vaccine delivery), increased immune responses in most participants with chronic hepatitis C. Although the vaccine alone had little effect on controlling the virus, it showed promise when combined with standard treatments, leading to virus clearance in some patients. ^{1 2 3 4 5}

Is the DNA vaccine for chronic hepatitis C safe for humans?

The DNA vaccine for chronic hepatitis C, including INO-8000, has been shown to be safe and well-tolerated in humans, with common mild-to-moderate reactions at the injection site. Studies have demonstrated that the vaccine regimen is safe and induces immune responses in most participants. ^{1 2 4 6 7}

How is the DNA vaccine treatment for chronic hepatitis C different from other treatments?

This DNA vaccine treatment for chronic hepatitis C is unique because it uses electroporation (a technique that uses electrical pulses to increase cell uptake) to deliver the vaccine directly into muscle cells, enhancing the immune response. Unlike standard treatments, it aims to boost the body's immune system to fight the virus by increasing specific T-cell responses, rather than directly targeting the virus itself. ^{1 2 4 8 9}

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection.

Research Team

Jeffrey M Jacobson

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with chronic Hepatitis C infection confirmed by positive HCV RNA. Participants must be willing to use contraception, avoid excessive alcohol, and provide blood samples. They should have an ECOG performance status of 0 or 1 and no history of severe allergies to similar compounds, autoimmune disorders, major organ transplants, cardiac arrhythmias, other liver diseases like hepatitis B or active malignancies.

Inclusion Criteria

Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation

Screening HCV genotype demonstrating genotype 1

Alpha feto protein (AFP) levels within normal institutional limits or judged to be not clinically significant

Exclusion Criteria

Other uncontrolled immune-compromising illness

Pregnant or nursing women

I do not have any unmanaged ongoing illnesses.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INO-8000 and INO-9012 intramuscularly followed by electroporation at day 0 and at weeks 4, 12, and 24

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

2 visits (in-person) at weeks 48 and 76

Treatment Details

Interventions

• Electroporation-Mediated Plasmid DNA Vaccine Therapy
• HCV DNA Vaccine INO-8000

Trial Overview The trial is testing the safety and optimal dosage of a DNA vaccine therapy (INO-8000) combined with electroporation against chronic Hepatitis C virus infection. It aims to see if this vaccine can stimulate the immune system effectively enough to fight off the virus.

Participant Groups

Group I: Treatment (INO-8000, INO-9012, EP) Experimental Treatment 5 Interventions

Patients receive INO-8000 IM and DNA plasmid encoding interleukin-12 INO-9012 IM (dose levels 2-4) followed by EP at day 0 and at weeks 4, 12, and 24.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Inovio Pharmaceuticals

Industry Sponsor

Trials

54

Recruited

4,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I Trial of a Therapeutic DNA Vaccine for Preventing Hepatocellular Carcinoma from Chronic Hepatitis C Virus (HCV) Infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Therapeutic DNA vaccination using in vivo electroporation followed by standard of care therapy in patients with genotype 1 chronic hepatitis C. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical development of intramuscular electroporation: providing a "boost" for DNA vaccines. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

In vivo electroporation enhances the immunogenicity of hepatitis C virus nonstructural 3/4A DNA by increased local DNA uptake, protein expression, inflammation, and infiltration of CD3+ T cells. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

DNA-based immunization breaks tolerance in a hepatitis C virus transgenic mouse model. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Immunization with a DNA vaccine candidate in chronic hepatitis C patients is safe, well tolerated and does not impair immune response induction after anti-hepatitis B vaccination. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. [2011]

8. United States pubmed.ncbi.nlm.nih.gov

Advances in DNA immunization against hepatitis C virus infection. [2019]

9. England pubmed.ncbi.nlm.nih.gov

DNA vaccine therapy for chronic hepatitis C virus (HCV) infection: immune control of a moving target. [2009]