DNA Vaccine for Chronic Hepatitis C

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byJeffrey M Jacobson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

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

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Exclusion Criteria

Other uncontrolled immune-compromising illness

Pregnant or nursing women

I do not have any unmanaged ongoing illnesses.

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Treatment Details

Interventions

Electroporation-Mediated Plasmid DNA Vaccine Therapy (Cancer Vaccine)
HCV DNA Vaccine INO-8000 (Cancer Vaccine)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Treatment (INO-8000, INO-9012, EP)Experimental Treatment5 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.