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Cancer Vaccine

DNA Vaccine for Chronic Hepatitis C

Phase 1

Waitlist Available

Led By Jeffrey M Jacobson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Be older than 18 years old

Must not have

Uncontrolled intercurrent illness

Failure of previous HCV therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the side effects and best dose of the DNA vaccine in treating patients with HCV infection. The vaccine may help the body build an effective immune response to kill cancer cells that express HCV infection.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, flu-like symptoms including fever and fatigue, muscle aches, headaches and possible mild skin reactions like rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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My previous treatments for hepatitis C were unsuccessful.

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I am HIV positive.

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I am currently infected with hepatitis B.

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I have liver scarring due to hepatitis C and symptoms affecting other parts of my body.

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I currently have cancer.

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I have a history of irregular heartbeats.

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I have or had a heart condition that causes rapid heartbeats.

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I don't have tattoos, scars, lesions, or rashes near the treatment area.

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I have had a major organ transplant and it is still working.

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I do not have other significant liver diseases.

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I have had a seizure in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose-limiting toxicity

Mean change of interferon-gamma production by peripheral blood mononuclear cells

Other study objectives

CD8 and CD4 T lymphocyte responses as measured by flow cytometry, and antibody responses, to hepatitis C virus antigen for the dose levels determined to be safe

Percentage of participants with > 1 log decrease (or undetectable) in hepatitis C virus ribonucleic acid level

Percentage of participants with end-of-treatment undetectable hepatitis C virus ribonucleic acid for the dose levels determined to be safe

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met