DNA Vaccine for Chronic Hepatitis C
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best dose and assess the side effects of a new DNA vaccine for individuals with chronic hepatitis C, a long-lasting liver infection. The vaccine, INO-8000, might enhance the body's ability to combat the infection. Participants will receive the vaccine through electroporation, a process that helps the DNA enter cells. Suitable candidates include those with an ongoing hepatitis C infection who have not experienced certain other health issues, such as HIV or recent liver treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new vaccine.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using systemic corticosteroids, you must stop them at least 4 weeks before joining the study, and inhaled corticosteroids must be stopped at least 48 hours before joining.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the INO-8000 vaccine, used with electroporation (a method using electrical pulses to help cells absorb DNA), has been tested for safety in individuals with long-term hepatitis C. Early studies indicate that this treatment is generally safe. Most participants did not experience serious side effects. Some reported mild reactions, such as soreness at the injection site or fatigue. These effects were temporary and resolved on their own.
The DNA vaccine aids the immune system in recognizing and combating the virus, enhancing the body's natural defenses. Although the current trial is in the early stages and more detailed safety information is still being collected, the absence of major negative effects so far suggests the treatment is relatively safe for individuals.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for chronic Hepatitis C, such as direct-acting antivirals (DAAs) that target the virus itself, the DNA vaccine INO-8000 offers a unique approach by harnessing the body's immune system to fight the virus. This treatment involves an innovative delivery method known as electroporation, which enhances the uptake of the DNA vaccine into cells, potentially leading to a more robust immune response. Researchers are excited because this method could provide long-lasting immunity and reduce the chances of the virus developing resistance, offering a new hope for patients with chronic Hepatitis C.
What evidence suggests that this DNA vaccine might be an effective treatment for chronic hepatitis C?
Studies have shown that the DNA vaccine INO-8000 for chronic hepatitis C is safe and generally well-tolerated. It helps the body recognize and fight the hepatitis C virus by triggering specific immune responses. In tests with mice, the vaccine removed hepatitis C markers from the liver, suggesting it might help clear the virus from the body. Early human trials confirmed that the vaccine produced immune responses specifically targeting hepatitis C, which are important for fighting the infection. While this is promising, more research is needed to understand its long-term effectiveness in people. Participants in this trial will receive INO-8000 along with INO-9012 and electroporation (EP) as part of the treatment regimen.23678
Who Is on the Research Team?
Jeffrey M Jacobson
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive INO-8000 and INO-9012 intramuscularly followed by electroporation at day 0 and at weeks 4, 12, and 24
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Electroporation-Mediated Plasmid DNA Vaccine Therapy
- HCV DNA Vaccine INO-8000
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Inovio Pharmaceuticals
Industry Sponsor
Citations
Phase I Trial of a Therapeutic DNA Vaccine for Preventing ...
We studied the safety and immunogenicity of a novel therapeutic hepatitis C virus (HCV) genotype 1a/1b consensus DNA vaccine, INO-8000, encoding HCV NS3, NS4A, ...
DNA Vaccine Therapy in Treating Patients With Chronic ...
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) ...
Phase I Trial of a Therapeutic DNA Vaccine for Preventing ...
The vaccine regimen was safe and induced HCV-specific CD4+ and CD8+ cellular immune responses of modest magnitude in most HCV-infected participants. The ...
DNA Vaccine for Chronic Hepatitis C · Info for Participants
The DNA vaccine for chronic hepatitis C, including INO-8000, has been shown to be safe and well-tolerated in humans, with common mild-to-moderate reactions at ...
Inovio Pharmaceuticals to Initiate Clinical Trial for its Hepatitis ...
In fact, using a transient HCV infection model in mice, therapeutic immunization with INO-8000 was able to clear HCV antigens from the liver, ...
DNA Vaccine Therapy in Treating Patients With Chronic ...
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 ) ...
Phase I Trial of a Therapeutic DNA Vaccine for Preventing ...
We studied the safety and immunogenicity of a novel therapeutic hepatitis C virus (HCV) genotype 1a/1b consensus DNA vaccine, INO-8000, encoding ...
8.
ir.inovio.com
ir.inovio.com/news-releases/news-releases-details/2014/Inovio-Pharmaceuticals-Unveils-Potent-New-Immune-Activator/default.aspxInovio Pharmaceuticals Unveils Potent New Immune Activator
... electroporation produced a vaccine specific CD4+ or CD8+ T cell response compared to 67% who received the DNA vaccine alone without the IL-12 ...
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