NCT02772003

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

Phase I Trial of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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. TRANSLATIONAL 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.

Conditions

• Chronic Hepatitis
• Hepatitis C Infection
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Electroporation-Mediated Plasmid DNA Vaccine Therapy	Undergo electroporation
BIOLOGICAL	HCV DNA Vaccine INO-8000	Given IM
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
BIOLOGICAL	Rocakinogene Sifuplasmid	Given IM

Timeline

• Start date: 2016-06-06
• Primary completion: 2020-03-04
• Completion: 2027-03-09
• First posted: 2016-05-13
• Last updated: 2026-04-13

Locations

5 sites across 2 countries: United States, Puerto Rico