Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT02772003
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase I Trial of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00558 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| HHSN261201200042I | None | None | View | |
| N01-CN-2012-00042 | None | None | View | |
| MAY2013-02-01 | OTHER | Mayo Clinic in Rochester | View | |
| MAY2013-02-01 | OTHER | DCP | View | |
| N01CN00042 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |