Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02822079
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 1
Start date June 2016

See also
  Status Clinical Trial Phase
Completed NCT01771653 - Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection N/A
Recruiting NCT03601546 - Feasibility of Implementing a Cohort of People Living With Hepatitis C in Vietnam
Completed NCT02362217 - A Study to Assess the Safety of HIV and Hep C Vaccine Candidates When Given Separately or in Combination Phase 1
Completed NCT00513461 - Liver Cancer Prevention Trial in Patients With Chronic Hep C Infection Phase 2
Active, not recruiting NCT02143401 - Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors Phase 1
Completed NCT02247401 - Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt Phase 3
Completed NCT02582632 - A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults Phase 3
Terminated NCT01532908 - Open Label Study of the Efficacy and Safety of MBL-HCV1 in Combination With Oral Direct-Acting Antivirals in Patients Undergoing Liver Transplantation for Hepatitis C Phase 2
Recruiting NCT01754961 - Effects of Vitamin D on Inflammation in Liver Disease Phase 2
Terminated NCT01465516 - Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir N/A
Completed NCT01265511 - Study of SCY-635, Pegasys and Copegus in Hepatitis C Phase 2
Completed NCT04042740 - Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection Phase 2
Not yet recruiting NCT05601518 - Efficacy and Safety of Coblopasvir Hydrochloride Capsules Combined With Sofosbuvir Tablets for the Treatment of Chronic HCV Infection: A Prospective, Multi-center Real-world Study.
Terminated NCT02429583 - Effects of Persistent Innate Immune Activation on Vaccine Efficacy Phase 4
Not yet recruiting NCT05506475 - Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam
Withdrawn NCT02112630 - Boceprevir in End Stage Renal Disease (ESRD) N/A
Terminated NCT01841502 - Interaction Between Paroxetine and Telaprevir Phase 2
Completed NCT02076100 - Safety, Pharmacokinetics, and Pharmacodynamics of Ruzasvir (MK-8408) in Participants With Hepatitis C Infection (MK-8408-003) Phase 1
Completed NCT01803308 - A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection Phase 1
Terminated NCT01560468 - Study of Hepatitis C Virus (HCV) Entry Inhibitor in Liver Transplant Recipients With HCV Infection Phase 1