Last updated on February 2019

DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection

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Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the safety profile of the HCV DNA vaccine, consisting of INO-8000 (HCV antigen DNA) alone or co-administered with INO-9012 (interleukin [IL]-12 adjuvant DNA) (DNA plasmid encoding interleukin-12 INO-9012).

II. To identify a dose of INO-9012 (IL-12 adjuvant DNA) for co-administration with INO-8000 (HCV antigen DNA) based on induction of HCV-specific interferon (IFN)-gamma production by peripheral blood mononuclear cells at 26 weeks compared to baseline in HCV-infected participants.

SECONDARY OBJECTIVES:

I. Determine the rate at which INO-8000 with different doses of INO-9012 induces a > 1 log decrease (or undetectable) in HCV ribonucleic acid (RNA) level at weeks 14 and 26.

II. Determine the rate at which INO-8000 with different doses of INO-9012 induces an end-of-treatment undetectable HCV RNA (end-of-treatment virologic response - EVR) at 26 weeks and a sustained virologic response (SVR) at 36 weeks.

III. Determine the rate at which INO-8000 with different doses of INO-9012 induces other parameters of cluster of differentiation (CD)8 and CD4 T lymphocyte responses as measured by flow cytometry, and antibody responses to HCV antigen at weeks 14 and 26.

OUTLINE: This is a dose-escalation study of INO-9012.

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

After completion of study treatment, patients are followed up at weeks 48 and 76.