NCT03180684 · REGISTRY CONDITION SEARCH

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)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2023-08-25

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples

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outcome · POSTED

Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose

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outcome · POSTED

Percentage of Participants With Adverse Events (AEs)

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outcome · POSTED

Percentage of Participants With No Histologic Evidence of Vulvar HSIL

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outcome · POSTED

Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples

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outcome · POSTED

Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue

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outcome · POSTED

Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on Histology

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outcome · POSTED

Percentage of Participants With No Progression of Vulvar HSIL to Vulvar Cancer

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outcome · POSTED

Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)

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outcome · POSTED

Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude

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outcome · POSTED

Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations

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outcome · POSTED

Change From Baseline in Flow Cytometry Response Magnitude

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Women aged 18 and above; * Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit; Exclusion Criteria: * Biopsy-proven differentiated VIN; * Any previous treatment for vulvar HSIL within 4 weeks prior to screening; * Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream; * Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product; * Immunosuppression as a result of underlying illness or treatment; * Significant acute or chronic medical illness.
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants with histologically confirmed vulvar high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV) 16 and/or 18, received four doses of 6 mg VGX-3100 as an intramuscular (IM) injection on Day 0, Week 4, Week 12, and Week 24 followed by electroporation (EP) using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
intervention Names
Biological: VGX-3100
Device: CELLECTRA™ 2000
label
VGX-3100 + EP
type
EXPERIMENTAL
description
Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
intervention Names
Biological: VGX-3100
Drug: Imiquimod 5% Cream
Device: CELLECTRA™ 2000
label
VGX-3100 + EP + Imiquimod
type
EXPERIMENTAL

interventions

arm Group Labels
VGX-3100 + EP
VGX-3100 + EP + Imiquimod
description
One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.
name
VGX-3100
type
BIOLOGICAL
arm Group Labels
VGX-3100 + EP + Imiquimod
description
Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
name
Imiquimod 5% Cream
type
DRUG
arm Group Labels
VGX-3100 + EP
VGX-3100 + EP + Imiquimod
description
IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.
name
CELLECTRA™ 2000
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 33
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
time Frame
Week 48

secondary Outcomes

description
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).
measure
Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose
time Frame
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)
description
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.
measure
Percentage of Participants With Adverse Events (AEs)
time Frame
From baseline up to Week 100
description
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.
measure
Percentage of Participants With No Histologic Evidence of Vulvar HSIL
time Frame
Week 48
description
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.
measure
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
time Frame
Week 48
description
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.
measure
Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue
time Frame
Week 48
description
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.
measure
Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on Histology
time Frame
Week 48
description
Non-progression of vulvar HSIL to vulvar cancer was evaluated from baseline to Week 48. Progression was defined as advancement to carcinoma by histology.
measure
Percentage of Participants With No Progression of Vulvar HSIL to Vulvar Cancer
time Frame
From baseline up to Week 48
description
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.
measure
Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
time Frame
From baseline to Week 48
description
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.
measure
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
time Frame
Baseline; Weeks 15, 27, 48, 74, and 96
description
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
measure
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
time Frame
Weeks 15, 27, 48, 74, and 96
description
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.
measure
Change From Baseline in Flow Cytometry Response Magnitude
time Frame
Baseline; Week 27

Full study description

brief Summary: 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

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice