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Cancer Vaccine

DNA Vaccine for Chronic Hepatitis C

Phase 1

Waitlist Available

Led By Jeffrey M Jacobson

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 weeks

Awards & highlights

Study Summary

This trial studies the side effects and best dose of the DNA vaccine in treating patients with HCV infection. The vaccine may help the body build an effective immune response to kill cancer cells that express HCV infection.

Who is the study for?

This trial is for adults with chronic Hepatitis C infection confirmed by positive HCV RNA. Participants must be willing to use contraception, avoid excessive alcohol, and provide blood samples. They should have an ECOG performance status of 0 or 1 and no history of severe allergies to similar compounds, autoimmune disorders, major organ transplants, cardiac arrhythmias, other liver diseases like hepatitis B or active malignancies.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosage of a DNA vaccine therapy (INO-8000) combined with electroporation against chronic Hepatitis C virus infection. It aims to see if this vaccine can stimulate the immune system effectively enough to fight off the virus.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain or swelling, flu-like symptoms including fever and fatigue, muscle aches, headaches and possible mild skin reactions like rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicity

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

Other outcome measures

CD8 and CD4 T lymphocyte responses as measured by flow cytometry, and antibody responses, to hepatitis C virus antigen for the dose levels determined to be safe

Percentage of participants with > 1 log decrease (or undetectable) in hepatitis C virus ribonucleic acid level

Percentage of participants with end-of-treatment undetectable hepatitis C virus ribonucleic acid for the dose levels determined to be safe

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (INO-8000, INO-9012, EP)Experimental Treatment5 Interventions

Patients 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Inovio PharmaceuticalsIndustry Sponsor

53 Previous Clinical Trials

4,806 Total Patients Enrolled

4 Trials studying Hepatitis C

94 Patients Enrolled for Hepatitis C

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,120 Total Patients Enrolled

12 Trials studying Hepatitis C

818,472 Patients Enrolled for Hepatitis C

Jeffrey M JacobsonPrincipal InvestigatorMayo Clinic

Media Library

Hepatitis C Research Study Groups: Treatment (INO-8000, INO-9012, EP)

Hepatitis C Clinical Trial 2023: Electroporation-Mediated Plasmid DNA Vaccine Therapy Highlights & Side Effects. Trial Name: NCT02772003 — Phase 1

Electroporation-Mediated Plasmid DNA Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02772003 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide a list of past experiments involving HCV DNA Vaccine INO-8000?

"Currently, 7 clinical trials are exploring the effectiveness of HCV DNA Vaccine INO-8000; none of these being at Phase 3. Primarily situated in Philadelphia, Pennsylvania, there are 60 sites that are testing this treatment across America."

Answered by AI

Has the FDA granted its seal of approval to INO-8000, a vaccine for Hepatitis C?

"While the data regarding INO-8000's efficacy and safety is yet to be confirmed, it has been given a tentative score of 1. This rating takes into account that this is only a Phase 1 trial."

Answered by AI

How many individuals have been enrolled in the experiment thus far?

"At this moment, the recruitment for this trial has concluded. The study was initially posted on June 6th 2016 and last updated September 20th 2022. If you are searching for other trials, there are currently 1029 clinical studies recruiting subjects with chronic hepatitis and 7 clinical trials seeking patients to test INO-8000 (a HCV DNA Vaccine)."

Answered by AI

Could you provide the number of US-based facilities running this research initiative?

"This clinical trial is based out of Temple University Hospital, Case Western Reserve University, and Mayo Clinic Rochester in the United States. Furthermore, 4 other medical sites are also involved in the research endeavour."

Answered by AI

Are researchers actively seeking participants for this trial?

"According to clinicaltrials.gov, the research is not presently enrolling any participants. This study was initially posted on June 6th of 2016 and updated for the last time on September 20th 2022; however, there are 1036 other trials that do have open recruitment windows at this moment in time."

Answered by AI

Has this medical experiment ever been conducted before?

"To date, there are 7 active clinical studies related to HCV DNA Vaccine INO-8000 across 33 cities and 4 countries. Inovio Pharmaceuticals launched the initial trial in 2016 and after Phase 1 approval it has completed 660 trials with over 33 participants involved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02772003.

All > Autoimmune Hepatitis > Hepatitis C