DNA vaccine trial aims to train immune system against hepatitis c
NCT ID NCT02772003
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This early-stage trial tests a DNA vaccine called INO-8000, given with an immune booster, to see if it can help people with chronic hepatitis C fight the virus. The study involves 33 participants and focuses on safety and finding the best dose. The vaccine is delivered through injection and a brief electrical pulse to help cells take up the DNA.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DNA vaccine (INO-8000) with an immune booster (INO-9012) given via injection and electroporation
- What this could lead to
- If it works, this could point toward a treatment that helps the immune system control chronic hepatitis C, potentially reducing the risk of liver cancer.
- What could go wrong
- This is a very early phase I trial with only 33 participants, so safety and dosing are the main focus. The vaccine may not produce a strong enough immune response, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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33 people
The number who actually took part.
- Started
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Jun 2016
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Western Reserve University
Cleveland, Ohio, 44106, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
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University of Puerto Rico
San Juan, 00936, Puerto Rico
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