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

Recruiting at 10 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

35 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment VGX-3100 + Electroporation for high-grade anal lesions in HIV?

Research shows that VGX-3100, when used with electroporation, can effectively stimulate the immune system to respond to HPV, which is similar to how it might work for high-grade anal lesions. Additionally, electroporation has been shown to enhance the effectiveness of DNA vaccines in other studies, suggesting it could improve the treatment's impact. ^{1 2 3 4 5}

Is the VGX-3100 treatment with electroporation safe for humans?

Electroporation, a method used to deliver DNA vaccines, has been shown to be safe in various studies involving healthy volunteers and animal models. These studies, which tested different DNA vaccines for HIV, reported no significant safety concerns when using electroporation. ^{3 5 6 7 8}

How is the treatment VGX-3100 with electroporation different from other treatments for high-grade anal lesions in HIV?

VGX-3100 is unique because it is a DNA-based vaccine that uses electroporation (a technique that uses electrical pulses to enhance the delivery of the vaccine into cells) to boost the immune response, which is not a common approach for treating high-grade anal lesions in HIV patients. ^{2 3 4 5 7}

What is the purpose of this trial?

This trial studies a DNA vaccine called VGX-3100 combined with a technique to help it enter cells, aiming to treat HIV-positive patients with severe anal lesions caused by HPV. The vaccine helps the immune system attack harmful cells, and the technique makes it easier for the vaccine to enter the cells. This combination aims to improve treatment effectiveness for these patients. VGX-3100 is being developed as an alternative to surgery for treating precancerous disease while preserving reproductive health.

Research Team

Chia-Ching (Jackie) Wang

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Enhancement of DNA vaccine potency in rhesus macaques by electroporation. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Optimizing the immunogenicity of HIV prime-boost DNA-MVA-rgp140/GLA vaccines in a phase II randomized factorial trial design. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Synthetic consensus HIV-1 DNA induces potent cellular immune responses and synthesis of granzyme B, perforin in HIV infected individuals. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

HIV-DNA Given with or without Intradermal Electroporation Is Safe and Highly Immunogenic in Healthy Swedish HIV-1 DNA/MVA Vaccinees: A Phase I Randomized Trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Robust antibody and cellular responses induced by DNA-only vaccination for HIV. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

A DNA-based candidate HIV vaccine delivered via in vivo electroporation induces CD4 responses toward the α4β7-binding V2 loop of HIV gp120 in healthy volunteers. [2021]