NCT03603808

VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions

Completed Phase 2 Last updated 16 July 2025

What this trial tests

Phase 2 trial testing Electroporation in Anal Intraepithelial Neoplasia in 35 participants. Completed in 17 June 2025.

Timeline

21 September 2018

Primary endpoint
31 December 2024

17 June 2025

Quick facts

Lead sponsor	AIDS Malignancy Consortium
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	21 September 2018
Primary completion	31 December 2024
Estimated completion	17 June 2025
Sites	8 locations across Puerto Rico, United States

Drugs / interventions tested

• Electroporation
• HPV DNA Plasmids Therapeutic Vaccine VGX-3100 — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →

Conditions studied

• Anal Intraepithelial Neoplasia — all drugs for Anal Intraepithelial Neoplasia →
• High Grade Squamous Intraepithelial Neoplasia — all drugs for High Grade Squamous Intraepithelial Neoplasia →
• HIV Positivity — all drugs for HIV Positivity →
• Human Papillomavirus-16 Positive — all drugs for Human Papillomavirus-16 Positive →

Sponsor

AIDS Malignancy Consortium

Who can join

18 and older, any sex, with Anal Intraepithelial Neoplasia or High Grade Squamous Intraepithelial Neoplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies the use of human papillomavirus (HPV) deoxyribonucleic acid (DNA) plasmids therapeutic vaccine VGX-3100 (VGX-3100) and electroporation in treating patients with human immunodeficiency virus (HIV)-positive high-grade anal lesions. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Electroporation helps pores in your body's cells take in the drug to strengthen your immune system's response. Giving VGX-3100 and electroporation together may work better in treating patients with high-grade anal lesions.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
   Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
2. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives.
   Lopes A, Vandermeulen G, Préat V. · · 2019 · cited 277× · PMID 30953535 · DOI 10.1186/s13046-019-1154-7
3. Therapeutic Vaccines for HPV-Associated Malignancies.
   Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
4. The next-generation DNA vaccine platforms and delivery systems: advances, challenges and prospects.
   Lu B, Lim JM, Yu B, Song S, et al · · 2024 · cited 84× · PMID 38361919 · DOI 10.3389/fimmu.2024.1332939
5. Strategies for improving the management of immune-related adverse events.
   Naing A, Hajjar J, Gulley JL, Atkins MB, et al · · 2020 · cited 67× · PMID 33310772 · DOI 10.1136/jitc-2020-001754
6. Therapeutic cancer vaccines: From biological mechanisms and engineering to ongoing clinical trials.
   Sobhani N, Scaggiante B, Morris R, Chai D, et al · · 2022 · cited 57× · PMID 35759856 · DOI 10.1016/j.ctrv.2022.102429
7. The future of cancer immunotherapy: DNA vaccines leading the way.
   Pandya A, Shah Y, Kothari N, Postwala H, et al · · 2023 · cited 53× · PMID 37294501 · DOI 10.1007/s12032-023-02060-3
8. Biopolymer-based Carriers for DNA Vaccine Design.
   Franck CO, Fanslau L, Bistrovic Popov A, Tyagi P, et al · · 2021 · cited 40× · PMID 32893932 · DOI 10.1002/anie.202010282