Trial Outcomes & Findings for 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) (NCT NCT03180684)
NCT ID: NCT03180684
Last Updated: 2023-08-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Week 48
Results posted on
2023-08-25
Participant Flow
Participants were enrolled at 20 study sites in the United States from 31 August 2017 to 18 December 2020.
A total of 70 participants were screened out of which 33 participants were enrolled in the study.
Participant milestones
| Measure |
VGX-3100 + EP
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.
|
VGX-3100 + EP + Imiquimod
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
8
|
|
Overall Study
Modified Intent-to-Treat (mITT) Population
|
25
|
8
|
|
Overall Study
Safety Population
|
25
|
8
|
|
Overall Study
COMPLETED
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
VGX-3100 + EP
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.
|
VGX-3100 + EP + Imiquimod
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject (Not Related to AE)
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Progressive Disease
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
VGX-3100 + EP
n=25 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.2 years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
45.4 years
STANDARD_DEVIATION 9.13 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 12.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
8 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Histologic Evidence of Vulvar HSIL and No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: 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)Population: Safety population included all participants who received at least one (1) dose of VGX-3100 (with or without EP).
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).
Outcome measures
| Measure |
VGX-3100 + EP
n=25 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With at Least One Local and Systemic Treatment-emergent Adverse Event (TEAE) During 7 Days Following Each Dose
|
84.0 percentage of participants
Interval 63.92 to 95.46
|
75.0 percentage of participants
Interval 34.91 to 96.81
|
SECONDARY outcome
Timeframe: From baseline up to Week 100Population: Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=25 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
92.0 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Histologic Evidence of Vulvar HSIL
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Vulvar Tissue Samples
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Histologic Evidence of Vulvar HSIL or No Evidence of HPV-16/18 in Vulvar Tissue
|
15.0 percentage of participants
Interval 3.2 to 37.9
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
SECONDARY outcome
Timeframe: Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Evidence of Vulvar HSIL, No Evidence of Vulvar LSIL (VIN1), and No Evidence of Condyloma on Histology
|
10.0 percentage of participants
Interval 1.2 to 31.7
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
SECONDARY outcome
Timeframe: From baseline up to Week 48Population: 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.
Non-progression of vulvar HSIL to vulvar cancer was evaluated from baseline to Week 48. Progression was defined as advancement to carcinoma by histology.
Outcome measures
| Measure |
VGX-3100 + EP
n=20 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Percentage of Participants With No Progression of Vulvar HSIL to Vulvar Cancer
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
100.0 percentage of participants
Interval 63.1 to 100.0
|
SECONDARY outcome
Timeframe: From baseline to Week 48Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=19 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=7 Participants
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.
|
|---|---|---|
|
Percent Change From Baseline in the Cumulative Surface Area of the Acetowhite Vulvar Lesion(s)
|
47.7 percent change in surface area
Standard Deviation 249.62
|
10.5 percent change in surface area
Standard Deviation 117.95
|
SECONDARY outcome
Timeframe: Baseline; Weeks 15, 27, 48, 74, and 96Population: 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. 'Number analyzed' indicates the number of participants available for analysis at individual time points.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=24 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=7 Participants
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.
|
|---|---|---|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Baseline)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 35.0
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 8.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Change From Baseline at Week 15)
|
0.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 78.33
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 43.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Change From Baseline at Week 27)
|
0.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 58.33
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 36.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Change From Baseline at Week 48)
|
0.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 56.67
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 3.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Change From Baseline at Week 74)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 30.0
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 25.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E6 (Change From Baseline at Week 96)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 38.33
|
0.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 8.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Baseline)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 15.0
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 1.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Change From Baseline at Week 15)
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 43.33
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 56.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Change From Baseline at Week 27)
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 71.67
|
6.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 40.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Change From Baseline at Week 48)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 31.67
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 25.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Change From Baseline at Week 74)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 15.0
|
0.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 21.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-16 E7 (Change From Baseline at Week 96)
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 3.33
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 0.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Baseline)
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 6.67
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 6.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Change From Baseline at Week 15)
|
19.167 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 593.33
|
10.000 spot forming units (SFU) per 10^6 cells
Interval 1.67 to 123.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Change From Baseline at Week 27)
|
10.833 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 908.33
|
5.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 146.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Change From Baseline at Week 48)
|
14.167 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 566.67
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 80.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Change From Baseline at Week 74)
|
8.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 925.0
|
9.167 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 45.0
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E6 (Change From Baseline at Week 96)
|
20.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 63.33
|
19.167 spot forming units (SFU) per 10^6 cells
Interval 1.67 to 48.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Baseline)
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 11.67
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 3.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Change From Baseline at Week 15)
|
2.500 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 51.67
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 16.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Change From Baseline at Week 27)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 33.33
|
6.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 43.33
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Change From Baseline at Week 48)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 51.67
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 21.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Change From Baseline at Week 74)
|
1.667 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 20.0
|
0.000 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 6.67
|
|
Change From Baseline in Interferon-Gamma (IFN-γ) Response Magnitude
HPV-18 E7 (Change From Baseline at Week 96)
|
3.333 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 5.0
|
4.167 spot forming units (SFU) per 10^6 cells
Interval 0.0 to 13.33
|
SECONDARY outcome
Timeframe: Weeks 15, 27, 48, 74, and 96Population: 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. 'Number analyzed' indicates the number of participants available for analysis at individual time points.
A standardized binding enzyme-linked immunosorbent assay (ELISA) was performed to measure the anti-HPV-16/18 antibody response induced by VGX-3100.
Outcome measures
| Measure |
VGX-3100 + EP
n=24 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=8 Participants
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.
|
|---|---|---|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-16 (Week 15)
|
7.3 reciprocal endpoint titer
Standard Deviation 3.22
|
13.1 reciprocal endpoint titer
Standard Deviation 2.89
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-16 (Week 27)
|
9.6 reciprocal endpoint titer
Standard Deviation 3.24
|
15.0 reciprocal endpoint titer
Standard Deviation 3.07
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-16 (Week 48)
|
15.9 reciprocal endpoint titer
Standard Deviation 3.33
|
17.2 reciprocal endpoint titer
Standard Deviation 3.06
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-16 (Week 74)
|
14.5 reciprocal endpoint titer
Standard Deviation 3.31
|
6.1 reciprocal endpoint titer
Standard Deviation 2.80
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-16 (Week 96)
|
37.0 reciprocal endpoint titer
Standard Deviation 3.13
|
11.4 reciprocal endpoint titer
Standard Deviation 2.85
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-18 (Week 15)
|
24.8 reciprocal endpoint titer
Standard Deviation 3.73
|
133.7 reciprocal endpoint titer
Standard Deviation 4.32
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-18 (Week 27)
|
44.7 reciprocal endpoint titer
Standard Deviation 3.67
|
89.4 reciprocal endpoint titer
Standard Deviation 4.85
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-18 (Week 48)
|
69.3 reciprocal endpoint titer
Standard Deviation 3.87
|
133.7 reciprocal endpoint titer
Standard Deviation 4.36
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-18 (Week 74)
|
83.2 reciprocal endpoint titer
Standard Deviation 3.98
|
45.0 reciprocal endpoint titer
Standard Deviation 4.23
|
|
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations
Anti-HPV-18 (Week 96)
|
2.9 reciprocal endpoint titer
Standard Deviation 1.86
|
2.2 reciprocal endpoint titer
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Baseline; Week 27Population: 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.
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.
Outcome measures
| Measure |
VGX-3100 + EP
n=22 Participants
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.
|
VGX-3100 + EP + Imiquimod
n=7 Participants
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.
|
|---|---|---|
|
Change From Baseline in Flow Cytometry Response Magnitude
Baseline
|
0.150 SFU/10^6 PBMC
Interval 0.0 to 14.5
|
1.250 SFU/10^6 PBMC
Interval 0.0 to 3.35
|
|
Change From Baseline in Flow Cytometry Response Magnitude
Change from Baseline at Week 27
|
0.000 SFU/10^6 PBMC
Interval 0.0 to 18.7
|
0.000 SFU/10^6 PBMC
Interval 0.0 to 7.7
|
Adverse Events
VGX-3100 + EP
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
VGX-3100 + EP + Imiquimod
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VGX-3100 + EP
n=25 participants at risk
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.
|
VGX-3100 + EP + Imiquimod
n=8 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Ulcer
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
Other adverse events
| Measure |
VGX-3100 + EP
n=25 participants at risk
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.
|
VGX-3100 + EP + Imiquimod
n=8 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
16.0%
4/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Cardiac disorders
Palpitations
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Ear and labyrinth disorders
Ear pain
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Eye disorders
Vision blurred
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Gastrointestinal disorders
Nausea
|
40.0%
10/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
37.5%
3/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site pain
|
72.0%
18/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
75.0%
6/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Fatigue
|
56.0%
14/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
50.0%
4/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site swelling
|
36.0%
9/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
37.5%
3/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site erythema
|
32.0%
8/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
37.5%
3/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site bruising
|
40.0%
10/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site pruritis
|
20.0%
5/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Malaise
|
16.0%
4/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Pyrexia
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Application site pain
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
General disorders
Pneumonia
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Investigations
Body temperature increased
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Investigations
Weight increased
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
48.0%
12/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
50.0%
4/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.0%
6/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
37.5%
3/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Nervous system disorders
Headache
|
40.0%
10/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
37.5%
3/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Nervous system disorders
Hypoaesthesia
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Nervous system disorders
Paraesthesia
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Psychiatric disorders
Depression
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Renal and urinary disorders
Urinary incontinence
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
20.0%
5/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulval disorder
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Dyspareunia
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
12.5%
1/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
25.0%
2/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
|
Vascular disorders
Hot flush
|
8.0%
2/25 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
0.00%
0/8 • From the first injection up to Week 100
Safety population included all participants who received at least 1 dose of VGX-3100 (with or without EP).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place