A Study of a Therapeutic DNA Vaccine for Chronic Hepatitis C Virus (HCV) Infection

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 13-008106
    • Rochester, Minnesota: 13-008106
    NCT ID: NCT02772003
    Sponsor Protocol Number: MAY2013-02-01

About this study

The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Presence of chronic Hepatitis C virus infection
  • Age ≥18 years
  • Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation
  • Willingness to avoid excessive use of alcohol during the study
  • Willingness to provide blood samples for research tests specified in the protocol
  • Ability to understand and willingness to sign a written informed consent document
  • Serum or plasma HCV RNA level ≥ 10,000 IU/mL
  • Screening HCV genotype, demonstrating genotype 1
  • Alpha feto protein (AFP) levels within normal institutional limits or judged to be not clinically significant by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Screening laboratory values (serum chemistry, hematology, prothrombin time (PT)(International Normalized Ratio (INR))/Activated Partial Thromboplastin Time (aPTT), and creatine phosphokinase (CPK)) within institutional normal range or judged to be not clinically significant by physician and medical monitor
  • 12-lead electrocardiogram (ECG) showing normal heart rhythm or judged to be not clinically significant by physician and medical monitor

Exclusion Criteria

  • Failure of previous HCV therapies
  • HIV infection
  • Any previous treatment for HCV ≤ 6 months prior to registration
  • Other uncontrolled immune-compromising illness
  • Autoimmune disorders, transplant recipients, other immunosuppression including any concurrent condition requiring the use of immunosuppressive/ immunomodulating agents
  • Ongoing HBV infection
  • Documented evidence of fibrosis or cirrhosis (Metavir 2, 3,and 4) and subjects with significant extrahepatic manifestations of hepatitis C (such as cryoglobulinemia with symptoms or evidence of end-organ manifestations, renal disease, type 2 diabetes, or porphyria cutanea tarda
  • Other known causes of significant liver disease including chronic or acute hepatitis B, acute hepatitis A, hemochromatosis, or homozygote alpha-1 antitrypsin deficiency
  • Active malignancy
  • History of major organ transplantation with an existing functional graft
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of cardiac arrhythmia, controlled or uncontrolled, including ventricular and supraventricular arrhythmia
  • Pregnant or nursing women
  • Current diagnosis or history of cardiac pre-excitation syndromes (e.g. Wolff-Parkinson-White)
  • Metal implants on same limb as intended administration site
  • Tattoos, scars, active lesions, or rashes within ≤ 2 cm of the intended site of study treatment
  • Documentation of history of seizure within previous 5 years
  • Pacemaker or other implanted device
  • Any condition that, in the clinical judgement of the investigator, would place a participant at unreasonably increased risk
  • Receiving any other investigational agents ≤ 6 months prior to registration
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to INO-8000 and INO-9012

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Lewis Roberts, M.B., Ch.B., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015