Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)
CompletedPhase 2Results postedLast updated 25 August 2023
What this trial tests
Phase 2 trial testing VGX-3100 in Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) in 33 participants. Completed in 18 December 2020.
18 and older, female only, with Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) or Vulvar Dysplasia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue SamplesPrimary· Week 48
A treatment responder for the primary endpoint was defined as a participant with no histologic evidence of vulvar HSIL (normal tissue or vulvar low grade squamous intraepithelial lesions (LSIL) \[vulval intraepithelial neoplasia 1 (VIN1)\] or condyloma) and no evidence of HPV-16 or HPV-18 (i.e., elimination of the specific genotypes \[16, 18, or both\]) in vulvar tissue at evaluation and who did not receive any non-study related treatment for vulvar HSIL. All lesions were evaluated for histologic evidence of vulvar HSIL or evidence of HPV-16/18 in vulvar tissue.
Group
Value
95% CI
VGX-3100 + EP
15.0
3.2 – 37.9
VGX-3100 + EP + Imiquimod
37.5
8.5 – 75.5
Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each DoseSecondary· 7 days following each dose: Day 0 (Days 0 to 7), Week 4 (Days 22 to 28), Week 12 (Days 78 to 84), Week 24 (Days 162 to 168), and Week 52 (Days 358 to 364)
An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product. A TEAE was defined per protocol as any AE with onset after the administration of study medication through the end of the study (i.e., study discharge).
Group
Value
95% CI
VGX-3100 + EP
84.0
63.92 – 95.46
VGX-3100 + EP + Imiquimod
75.0
34.91 – 96.81
Percentage of Participants With Adverse Events (AEs)Secondary· From baseline up to Week 100
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body, or worsening of a pre-existing condition, temporally associated with the use of a product whether or not considered related to the use of the product.
Group
Value
95% CI
VGX-3100 + EP
92.0
VGX-3100 + EP + Imiquimod
100
Percentage of Participants With No Histologic Evidence of Vulvar HSILSecondary· Week 48
Participants with no histologic evidence of vulvar HSIL (normal tissue or vulvar LSIL \[VIN1\] or condyloma) based on histology (i.e. biopsies or excisional treatment) were considered. All lesions were evaluated for histologic evidence of vulvar HSIL.
Group
Value
95% CI
VGX-3100 + EP
15.0
3.2 – 37.9
VGX-3100 + EP + Imiquimod
37.5
8.5 – 75.5
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue SamplesSecondary· Week 48
Participants with no evidence of HPV-16 and/or HPV-18 indicated the clearance of the specific HPV genotypes \[16, 18, or both\]. All lesions were evaluated for evidence of HPV-16/18 in vulvar tissue.
Group
Value
95% CI
VGX-3100 + EP
15.0
3.2 – 37.9
VGX-3100 + EP + Imiquimod
50.0
15.7 – 84.3
Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar TissueSecondary· Week 48
A treatment responder for the endpoint was defined as a participant with no histologic evidence of vulvar HSIL (normal tissue or LSIL \[VIN1\] or condyloma) based on histology (i.e. biopsies or excisional treatment) or no evidence of HPV-16 or HPV-18 (i.e., elimination of the specific genotypes \[16, 18, or both\]) in vulvar tissue at evaluation and who did not receive any non-study related treatment for vulvar HSIL. All lesions were evaluated for histologic evidence of vulvar HSIL or evidence of HPV-16/18 in vulvar tissue.
Group
Value
95% CI
VGX-3100 + EP
15.0
3.2 – 37.9
VGX-3100 + EP + Imiquimod
50.0
15.7 – 84.3
Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on HistologySecondary· Week 48
Histologic regression was defined as a participant with no histologic evidence of vulvar HSIL, no evidence of LSIL (VIN1), and no evidence of condyloma. Histologic regression of vulvar HSIL to normal tissue was assessed.
Group
Value
95% CI
VGX-3100 + EP
10.0
1.2 – 31.7
VGX-3100 + EP + Imiquimod
37.5
8.5 – 75.5
Percentage of Participants With No Progression of Vulvar HSIL to Vulvar CancerSecondary· From baseline up to Week 48
Non-progression of vulvar HSIL to vulvar cancer was evaluated from baseline to Week 48. Progression was defined as advancement to carcinoma by histology.
Group
Value
95% CI
VGX-3100 + EP
100.0
83.2 – 100.0
VGX-3100 + EP + Imiquimod
100.0
63.1 – 100.0
Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)Secondary· From baseline to Week 48
Lesion(s), defined as areas that stain acetowhite were assessed. Analysis of qualifying lesions was defined as the change in total surface area of only lesions with both baseline and Week 48 measurements. Percent change in the cumulative surface area of the acetowhite vulvar lesion(s) was determined by the quantitative analysis of standardized prebiopsy photographic imaging of qualifying lesion(s) at Week 48 compared to baseline.
Group
Value
95% CI
VGX-3100 + EP
47.7
± 249.62
VGX-3100 + EP + Imiquimod
10.5
± 117.95
Change From Baseline in Interferon-Gamma (IFN-γ) Response MagnitudeSecondary· Baseline; Weeks 15, 27, 48, 74, and 96
Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood samples. Assessment of cellular immune activity was performed by IFN-γ enzyme-linked immunosorbent spot-forming (ELISpot) assay.
HPV-16 E6 (Baseline)
Group
Value
95% CI
VGX-3100 + EP
1.667
0.00 – 35.00
VGX-3100 + EP + Imiquimod
1.667
0.00 – 8.33
HPV-16 E6 (Change From Baseline at Week 15)
Group
Value
95% CI
VGX-3100 + EP
0.833
0.00 – 78.33
VGX-3100 + EP + Imiquimod
0.000
0.00 – 43.33
HPV-16 E6 (Change From Baseline at Week 27)
Group
Value
95% CI
VGX-3100 + EP
0.833
0.00 – 58.33
VGX-3100 + EP + Imiquimod
3.333
0.00 – 36.67
HPV-16 E6 (Change From Baseline at Week 48)
Group
Value
95% CI
VGX-3100 + EP
0.833
0.00 – 56.67
VGX-3100 + EP + Imiquimod
0.000
0.00 – 3.33
HPV-16 E6 (Change From Baseline at Week 74)
Group
Value
95% CI
VGX-3100 + EP
1.667
0.00 – 30.00
VGX-3100 + EP + Imiquimod
0.000
0.00 – 25.00
HPV-16 E6 (Change From Baseline at Week 96)
Group
Value
95% CI
VGX-3100 + EP
1.667
0.00 – 38.33
VGX-3100 + EP + Imiquimod
0.833
0.00 – 8.33
HPV-16 E7 (Baseline)
Group
Value
95% CI
VGX-3100 + EP
1.667
0.00 – 15.00
VGX-3100 + EP + Imiquimod
0.000
0.00 – 1.67
HPV-16 E7 (Change From Baseline at Week 15)
Group
Value
95% CI
VGX-3100 + EP
3.333
0.00 – 43.33
VGX-3100 + EP + Imiquimod
1.667
0.00 – 56.67
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody ConcentrationsSecondary· Weeks 15, 27, 48, 74, and 96
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
Anti-HPV-16 (Week 15)
Group
Value
95% CI
VGX-3100 + EP
7.3
± 3.22
VGX-3100 + EP + Imiquimod
13.1
± 2.89
Anti-HPV-16 (Week 27)
Group
Value
95% CI
VGX-3100 + EP
9.6
± 3.24
VGX-3100 + EP + Imiquimod
15.0
± 3.07
Anti-HPV-16 (Week 48)
Group
Value
95% CI
VGX-3100 + EP
15.9
± 3.33
VGX-3100 + EP + Imiquimod
17.2
± 3.06
Anti-HPV-16 (Week 74)
Group
Value
95% CI
VGX-3100 + EP
14.5
± 3.31
VGX-3100 + EP + Imiquimod
6.1
± 2.80
Anti-HPV-16 (Week 96)
Group
Value
95% CI
VGX-3100 + EP
37.0
± 3.13
VGX-3100 + EP + Imiquimod
11.4
± 2.85
Anti-HPV-18 (Week 15)
Group
Value
95% CI
VGX-3100 + EP
24.8
± 3.73
VGX-3100 + EP + Imiquimod
133.7
± 4.32
Anti-HPV-18 (Week 27)
Group
Value
95% CI
VGX-3100 + EP
44.7
± 3.67
VGX-3100 + EP + Imiquimod
89.4
± 4.85
Anti-HPV-18 (Week 48)
Group
Value
95% CI
VGX-3100 + EP
69.3
± 3.87
VGX-3100 + EP + Imiquimod
133.7
± 4.36
Change From Baseline in Flow Cytometry Response MagnitudeSecondary· Baseline; Week 27
Assessment of cellular immune activity was measured using the application of flow cytometry for the purpose of performing a Lytic Granule Loading Assay. The Lytic Granule Loading Assay examines the following external cellular markers: cluster of differentiation 3 (CD3), CD4, CD8 (T-cell identification), CD137, CD38, and CD69 (T-cell activation markers) as well as PD-1 (exhaustion/activation marker). Here, a change from baseline in CD8+/CD137+ PBMCs expressing Perforin+ was reported.
Baseline
Group
Value
95% CI
VGX-3100 + EP
0.150
0.00 – 14.50
VGX-3100 + EP + Imiquimod
1.250
0.00 – 3.35
Change from Baseline at Week 27
Group
Value
95% CI
VGX-3100 + EP
0.000
0.00 – 18.70
VGX-3100 + EP + Imiquimod
0.000
0.00 – 7.70
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first injection up to Week 100.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03721978 — REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
· Phase 3
· completed
NCT03499795 — VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Relat
· Phase 2
· completed
NCT03185013 — REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inovio Pharmaceuticals
Last refreshed: 25 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03180684.