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)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.

→

secondary · POSTED

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).

Safety population included all participants who received at least one (1) dose of VGX-3100 (with or without EP).

→

secondary · POSTED

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.

Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

secondary · POSTED

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id: NCT03180684
trial label: 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)
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0000
source section id
NCT03180684-om-0000
source outcome index
0
endpoint
Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
endpoint definition
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.
time origin
Week 48
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0001
source section id
NCT03180684-om-0001
source outcome index
1
endpoint
Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose
endpoint definition
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).
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population included all participants who received at least one (1) dose of VGX-3100 (with or without EP).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0002
source section id
NCT03180684-om-0002
source outcome index
2
endpoint
Percentage of Participants With Adverse Events (AEs)
endpoint definition
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.
time origin
From baseline up to Week 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0003
source section id
NCT03180684-om-0003
source outcome index
3
endpoint
Percentage of Participants With No Histologic Evidence of Vulvar HSIL
endpoint definition
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.
time origin
Week 48
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0004
source section id
NCT03180684-om-0004
source outcome index
4
endpoint
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
endpoint definition
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.
time origin
Week 48
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0005
source section id
NCT03180684-om-0005
source outcome index
5
endpoint
Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue
endpoint definition
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.
time origin
Week 48
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
mITT population included all participants who received at least 1 dose of VGX-3100 + EP (with or without imiquimod) and had an analysis endpoint of interest. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0000
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0000
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0001
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0001
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0002
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0002
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0003
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0003
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0004
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0004
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0005
arm key
OG000
arm label
VGX-3100 + EP
regimen
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.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
outcome key
om-0005
arm key
OG001
arm label
VGX-3100 + EP + Imiquimod
regimen
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.
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03180684-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
harm key
EG000
source section id
NCT03180684-ae
event group key
EG000
event group label
VGX-3100 + EP
serious affected
3
serious at risk
25
other affected
23
other at risk
25
frequency threshold
5
collection period
From the first injection up to Week 100
event definition
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-high-grade-vulvar-squamous-intraepithelial-lesion
nct id
NCT03180684
harm key
EG001
source section id
NCT03180684-ae
event group key
EG001
event group label
VGX-3100 + EP + Imiquimod
serious affected
0
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
From the first injection up to Week 100
event definition
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice