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Cancer Vaccine

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

Phase 2
Waitlist Available
Led By Chia-Ching (Jackie) Wang
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-proven intra-anal or per-HSIL at baseline
Must be positive for HPV-16 or -18 on genotyping performed on screening anal swab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 26, 36, 48, 60, and 72 weeks
Awards & highlights

Study Summary

This trial is studying the use of a human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine (VGX-3100) and electroporation to treat patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection/electroporation site such as pain or swelling, general symptoms like fever or fatigue, and potential immune responses that could affect organ function. The extent of side effects will vary among participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My biopsy showed I have high-grade anal lesions.
Select...
I tested positive for HPV-16 or -18 from an anal swab.
Select...
I am on a working antiretroviral therapy for HIV.
Select...
I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 26, 36, 48, 60, and 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 26, 36, 48, 60, and 72 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
Overall response rate at 48 weeks
Secondary outcome measures
Complete response rate
Overall response rate at 72 weeks
Safety and tolerability of treatment as assessed by incidence of adverse events
+2 more
Other outcome measures
Antibody responses to HPV-16 and HPV-18 E6 and E7
Antibody responses to HPV-16 and HPV-18 E6 and E7 with fourth dose
CD4+ lymphocyte count and complete response
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (VGX-3100, electroporation)Experimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electroporation
2015
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,546 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,566 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
144 Previous Clinical Trials
1,050,811 Total Patients Enrolled

Media Library

VGX-3100 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03603808 — Phase 2
Human Papillomavirus Research Study Groups: Treatment (VGX-3100, electroporation)
Human Papillomavirus Clinical Trial 2023: VGX-3100 Highlights & Side Effects. Trial Name: NCT03603808 — Phase 2
VGX-3100 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03603808 — Phase 2

Frequently Asked Questions

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

How many medical facilities are participating in this research project?

"The 6 available trial sites include the Anal Dysplasia Clinic MidWest in Chicago, Cornell Clinical Trials Unit in New york, and Boston Medical Centerin Boston; three more are scattered across the continent."

Answered by AI

Are there any antecedent endeavors examining the effects of Electroporation?

"At this time, Electroporation is being tested in two separate clinical studies. None of these are in the third phase yet; however, they're all based out of Houston, Texas and across 8 different sites."

Answered by AI

How many participants are being accepted into this research program?

"This clinical trial requires 80 participants that qualify for its criteria to be recruited. Individuals hoping to join have the option of signing up at Anal Dysplasia Clinic MidWest in Chicago, IL or Cornell Clinical Trials Unit in New york, NY."

Answered by AI

What risks are associated with the Electroporation procedure?

"Taking into consideration the Phase 2 trial data, our team at Power rates Electroporation's safety as a score of two. While there is evidence suggesting its safety, no clinical research has been conducted to assess efficacy."

Answered by AI

Is this trial a pioneering endeavor?

"Presently, two Electroporation trials are underway at 6 various locations across 2 countries. This technology was first tested back in 2018 by Inovio Pharmaceuticals with 80 participants; it succeeded the Phase 2 trial and has since been employed in 581 experiments."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Affirmative. Data found on clinicaltrials.gov demonstrate that this medical experiment, which was launched on September 21st 2018, is actively recruiting volunteers. Eighty participants are needed from 6 different healthcare centres."

Answered by AI
~40 spots leftby Sep 2029