Last updated on June 2016

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


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 deoxyribonucleic acid (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 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 ribonucleic acid (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.

Clinical Study Identifier: NCT02822079

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