VGX-3100 + Electroporation for High-Grade Anal Lesions in HIV

No longer recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AIDS Malignancy Consortium

Must be taking: Antiretrovirals

Must not be taking: Corticosteroids, Immunosuppressives, Chemotherapy, others

Disqualifiers: Anal cancer, Cardiac disease, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treat high-grade anal lesions in individuals living with HIV. It combines a DNA-based vaccine, VGX-3100, with electroporation, a technique that enhances vaccine absorption. The goal is to boost the immune system's ability to combat these lesions, which can be precursors to cancer. Individuals who are HIV positive, have specific high-grade anal lesions, and are on effective antiretroviral therapy might be eligible to participate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on an effective HIV treatment regimen. Some medications, like certain steroids or blood thinners, may need to be adjusted or stopped before participating.

Is there any evidence suggesting that VGX-3100 and electroporation are likely to be safe?

Research has shown that VGX-3100, when used with electroporation, has been safe in past studies. One study found that VGX-3100 was well-tolerated and effective for treating HPV-related anal lesions, with no serious side effects directly linked to the treatment. Some patients experienced mild side effects, such as soreness at the injection site, but these were temporary.

VGX-3100 has also been tested for other conditions, like cervical lesions, and demonstrated similar safety results. This supports its potential safety for treating high-grade anal lesions in this trial. It is important to consult a healthcare provider to understand the possible risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VGX-3100 for high-grade anal lesions in people with HIV because it uses a unique approach to tackle the problem. Unlike traditional treatments that might rely on surgical removal or topical therapies, VGX-3100 is a therapeutic vaccine made from HPV DNA plasmids. This means it works by training the body's immune system to fight off the HPV virus, which is responsible for these lesions. Additionally, the treatment is delivered using electroporation, a method that enhances the uptake of the vaccine by briefly opening cell membranes, potentially making it more effective. This innovative combination of a DNA-based vaccine and advanced delivery method offers a promising new direction for treating these challenging lesions.

What evidence suggests that VGX-3100 and electroporation might be effective for high-grade anal lesions in HIV?

Research shows that VGX-3100, used with electroporation (a technique that enhances cellular absorption of the treatment), has promising results. In earlier studies, this combination cleared HPV-16/18-related precancerous anal lesions in 50% of patients six months after treatment. In this trial, participants will receive VGX-3100, a DNA vaccine that aims to strengthen the immune system to fight HPV-related lesions, along with electroporation. This method helps the body find and remove abnormal cells caused by the virus. Electroporation enhances the treatment by improving cellular uptake of the vaccine. These findings strongly suggest it could effectively treat high-grade anal lesions in people with HIV. ^{1 3 4 5 6}

Who Is on the Research Team?

Chia-Ching (Jackie) Wang

Principal Investigator

AIDS Malignancy Consortium

Are You a Good Fit for This Trial?

This trial is for HIV-positive individuals with high-grade anal lesions caused by HPV-16 or -18, who have a life expectancy over 5 years and are on effective antiretroviral therapy. They must have certain blood cell counts within normal ranges and be willing to use contraception. People with recent HSIL treatment, allergies to similar drugs, metal implants near the electroporation site, uncontrolled illnesses, or those on certain medications can't join.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

My biopsy showed I have high-grade anal lesions.

I tested positive for HPV-16 or -18 from an anal swab.

Exclusion Criteria

Received any other investigational agents within the 4 weeks before enrollment, other than investigational antiretroviral agents for HIV and investigational agents for hepatitis C

I have had treatment or removal of high-grade lesions less than 3 months ago.

I haven't taken steroids or immunosuppressants in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HPV DNA plasmids therapeutic vaccine VGX-3100 intramuscularly and undergo electroporation for 4 doses in weeks 0, 4, 12, and 24

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Long-term follow-up

Participants are monitored for overall response rate and other outcomes

72 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroporation
• VGX-3100

Trial Overview

The study tests VGX-3100 (an HPV DNA vaccine) combined with electroporation against high-grade anal lesions in HIV-positive patients. Electroporation helps cells absorb the vaccine better, potentially enhancing immune response to kill tumor cells.

How Is the Trial Designed?

Group I: Treatment (VGX-3100, electroporation) Experimental Treatment 3 Interventions

Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Recruited

9,600+

University of Arkansas

Collaborator

Trials

500

Recruited

153,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

AIDS and Cancer Specimen Resource

Collaborator

Trials

8

Recruited

990+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Inovio Pharmaceuticals

Industry Sponsor

Trials

54

Recruited

4,800+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03603808

NCT03603808 | VGX-3100 and Electroporation in Treating ...

Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions. Detailed Description. PRIMARY OBJECTIVES: I. To ...

2.

ir.inovio.com

ir.inovio.com/news-releases/news-releases-details/2020/INOVIOs-VGX-3100-Demonstrates-Positive-Phase-2-Efficacy-In-Treatment-of-Precancerous-Anal-Dysplasia-Caused-by-HPV-1618/default.aspx

INOVIO's VGX-3100 Demonstrates Positive Phase 2 Efficacy ...

DNA immunotherapy candidate VGX-3100 demonstrated resolution of HPV-16/18-associated precancerous anal lesions in 50% of treated patients six months after ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03499795

Study Details | NCT03499795 | VGX-3100 Delivered ...

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and ...

4.

ctv.veeva.com

ctv.veeva.com/study/vgx-3100-delivered-intramuscularly-im-followed-by-electroporation-ep-for-the-treatment-of-hpv16

VGX-3100 Delivered Intramuscularly (IM) Followed by ...

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in ...

5.

cochranelibrary.com

cochranelibrary.com/central/doi/10.1002/central/CN-01700944/related-content

REVEAL 2 Trial (Evaluation of VGX-3100 and ...

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL). NCT03721978. https://clinicaltrials.gov/ct2/show/NCT03721978, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7482708/

Safety and immunogenicity of VGX-3100 formulations in a ...

We now report immunogenicity and safety of VGX-3100 for a refrigeration-stable formulation, which improves patient-care setting usability.