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Chronic HepatitisPhase 1NCT02772003

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

A Phase 1 study testing Electroporation-Mediated Plasmid DNA Vaccine Therapy, HCV DNA Vaccine INO-8000 and Laboratory Biomarker Analysis in people with Chronic Hepatitis and Hepatitis C Infection, run by National Cancer Institute (NCI) at 5 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electroporation-Mediated Plasmid DNA Vaccine Therapy, HCV DNA Vaccine INO-8000 and Laboratory Biomarker Analysis
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
5 sitesin 2 countries
Study dates
6 Jun 2016to 9 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRE-REGISTRATION INCLUSION CRITERIA
  • Presence of active, chronic HCV infection confirmed by positive HCV RNA
  • Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation; Note:
  • The effects of INO-8000 with or without INO-9012 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • For men and women who are not postmenopausal (i.e., >= 12 months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone [FSH], if not on hormone replacement) or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females), agreement to remain abstinent or use highly effective or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and at least through week 12 after last dose
  • Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
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  • Examples of contraceptive methods with an expected failure rate of < 1% per year include male sterilization and hormonal implants; alternatively, proper use of combined oral or injected hormonal contraceptives and certain intrauterine devices or two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year (barrier methods must always be supplemented with the use of a spermicide)
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • Should a female partner of a male study participant become pregnant while the male participant is on study, the male participant should inform his study physician immediately
  • Willingness to avoid excessive use of alcohol during the study; note: excessive use is defined as drinking >= 8 alcoholic drinks per week on average
  • Willingness to provide blood samples for research tests specified in the protocol
  • Ability to understand and willingness to sign a written informed consent document
  • REGISTRATION INCLUSION CRITERIA
  • 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; Exception: If deemed clinically significant, then liver imaging must be available within previous 6 months (e.g., ultrasound, computed tomography [CT] scan, magnetic resonance imaging [MRI]) showing no evidence of hepatocellular carcinoma
  • 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]) obtained up to 45 days prior to administration of first vaccine injection on day 0 within institutional normal range or judged to be not clinically significant by principal investigator (PI) and medical monitor
  • 12-lead electrocardiogram (ECG) showing normal heart rhythm; note: if there are abnormalities, then the abnormalities must be deemed of no clinical significance

Who cannot join

  • PRE-REGISTRATION EXCLUSION CRITERIA
  • Failure of previous HCV therapies
  • Human immunodeficiency virus (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; Exception: eye drop-containing and infrequent inhaled corticosteroids are permissible; topical corticosteroids are permissible at locations other than the administration site (upper arm); Note: All systemic corticosteroids must be discontinued at least 4 weeks prior to randomization; inhaled corticosteroids must be discontinued >= 48 hours prior to randomization and courses of more than 2 weeks are not permissible within 4 weeks of randomization
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  • Ongoing hepatitis B virus (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; exception: non-melanoma skin cancers cancer(s) for which diagnosis and treatment was completed >= 3 years prior to pre-registration
  • 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, cardiac arrhythmia, 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; Note: Pregnant women are excluded from this study because INO-8000 has an unknown potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with this DNA vaccine, breastfeeding should be discontinued if the mother is treated with INO-8000
  • 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 =< 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
  • REGISTRATION EXCLUSION CRITERIA
  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

Puerto Rico1 site

  • University of Puerto Rico

    San Juan, 00936

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Electroporation-Mediated Plasmid DNA Vaccine Therapy, HCV DNA Vaccine INO-8000, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Rocakinogene Sifuplasmid
Medical subject headings
Hepatitis, Chronic, Hepatitis C, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electroporation-Mediated Plasmid DNA Vaccine TherapyBiological

    Undergo electroporation

  • HCV DNA Vaccine INO-8000Biological

    Also called INO-8000

    Given IM

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Rocakinogene SifuplasmidBiological

    Also called DNA Plasmid Encoding Interleukin-12 INO-9012, INO-9012

    Given IM

Study groups in NCT02772003
Study groupRoleWhat they receive
Treatment (INO-8000, INO-9012, EP)ExperimentalPatients receive INO-8000 IM and DNA plasmid encoding interleukin-12 INO-9012 IM (dose levels 2-4) followed by EP at day 0 and at weeks 4, 12, and 24.
Receives: Biological: Electroporation-Mediated Plasmid DNA Vaccine Therapy; Biological: HCV DNA Vaccine INO-8000; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Biological: Rocakinogene Sifuplasmid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicity

    Will be defined as an adverse event occurring after the initial vaccine administration, based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The percentage of participants who experience grade 3 or worse adverse events and administration-site reactions following each dose will be summarized using descriptive statistics across each dose level.

    Measured: Baseline to 26 weeks

  2. Mean change of interferon-gamma production by peripheral blood mononuclear cells

    Change in production of interferon-gamma by peripheral blood mononuclear cells will be based on a one-way analysis of variance model using data from all dose levels at the 2-sided 5% level. Mean change (and % change) and the associated 95% confidence intervals in the production of IFN-gamma by peripheral blood mononuclear cells for all evaluable participants enrolled at each dose level will be computed, and compared across the dose levels in an exploratory fashion using graphical approaches, one-way analysis of variance models etc. to ascertain a dose-response curve.

    Measured: Baseline to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study start6 Jun 2016
  3. Primary completion4 Mar 2020
  4. Study completion9 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02772003
Sponsor's protocol ID
NCI-2015-00558
Other IDs
NCI-2015-00558, HHSN261201200042I, N01-CN-2012-00042, MAY2013-02-01, MAY2013-02-01, N01CN00042, P30CA015083
Status last verified
Sep 2026
First submitted
27 Apr 2016
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Electroporation-Mediated Plasmid DNA Vaccine Therapy, HCV DNA Vaccine INO-8000 and Laboratory Biomarker Analysis in people with Chronic Hepatitis and Hepatitis C Infection, run by National Cancer Institute (NCI) at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (time frame: Baseline to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02772003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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