Trial Outcomes & Findings for REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) (NCT NCT03185013)

Last Updated: 2023-07-27

Results Overview

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

201 participants

Primary outcome timeframe

Week 36

Results posted on

2023-07-27

Participant Flow

Participants took part in the study at 96 study centers in 20 countries from 28 June 2017 to 6 April 2021.

A total of 201 participants with human papillomavirus (HPV)-16 and/or HPV-18 related high-grade squamous intraepithelial lesion (HSIL) of the cervix were randomized in this study, 138 in VGX-3100+EP and 63 in Placebo + EP.

Participant milestones

Participant milestones
Measure	VGX-3100 + Electroporation (EP) Participants received three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Overall Study STARTED	138	63
Overall Study Intent-to-Treat (ITT) Population	138	63
Overall Study Modified ITT (mITT) Population	134	63
Overall Study Safety Population	136	63
Overall Study COMPLETED	116	56
Overall Study NOT COMPLETED	22	7

Reasons for withdrawal

Reasons for withdrawal
Measure	VGX-3100 + Electroporation (EP) Participants received three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Overall Study Withdrawal by Subject	5	3
Overall Study Adverse Event	1	0
Overall Study Progressive Disease	1	0
Overall Study Lost to Follow-up	8	2
Overall Study Physician Decision	1	0
Overall Study Protocol Deviation	2	0
Overall Study Reason not Specified	3	2
Overall Study Death	1	0

Baseline Characteristics

REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Total n=201 Participants Total of all reporting groups
Age, Continuous	31.3 years STANDARD_DEVIATION 6.53 • n=5 Participants	31.9 years STANDARD_DEVIATION 6.08 • n=7 Participants	31.5 years STANDARD_DEVIATION 6.38 • n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	63 Participants n=7 Participants	201 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	22 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=5 Participants	54 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	109 Participants n=5 Participants	46 Participants n=7 Participants	155 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples	22.5 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: From baseline up to Week 88

Population: Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE is any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=136 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=62 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study Number of Participants with any AE	131 Participants	61 Participants
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study Number of Participants with any SAE	13 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Evidence of Cervical HSIL on Histology	31.9 percentage of participants	19.0 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing	34.1 percentage of participants	15.9 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at the Week 36 time frame and participants in which an excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Evidence of LSIL or HSIL on Histology	24.6 percentage of participants	11.1 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no histologic evidence of cervical HSIL, squamous atypia, and LSIL, no evidence of HPV-16 and/or HPV-18 by type specific HPV testing at the Week 36 time, and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18	18.1 percentage of participants	6.3 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no histologic evidence of cervical Adenocarcinoma in situ or cervical carcinoma at the Week 36 timeframe relative to baseline and participants in which an excision or biopsy sample was not obtained between initial dose up to Week 36 were considered as responders.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma	84.1 percentage of participants	85.7 percentage of participants

SECONDARY outcome

Timeframe: Week 36

Population: ITT population included all participants who were randomized.

Participants with no evidence of HPV-16 and/or HPV-18 on specimens from noncervical anatomic locations (oropharynx, vagina and intra-anal) at the Week 36 time frame were considered as responder.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=138 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=63 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations	20.3 percentage of participants	9.5 percentage of participants

SECONDARY outcome

Timeframe: Week 15 and Week 36

Population: mITT population included all participants who received at least one dose of clinical trial treatment and who had the analysis endpoint of interest. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

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

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=128 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=61 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations HPV-18 E7 at Week 36	225.0 reciprocal endpoint titer Interval 1.0 to 18225.0	1.0 reciprocal endpoint titer Interval 1.0 to 2025.0
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations HPV-16 E7 at Week 15	225.0 reciprocal endpoint titer Interval 1.0 to 18225.0	1.0 reciprocal endpoint titer Interval 1.0 to 6075.0
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations HPV-16 E7 at Week 36	1.0 reciprocal endpoint titer Interval 1.0 to 18225.0	1.0 reciprocal endpoint titer Interval 1.0 to 6075.0
Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations HPV-18 E7 at Week 15	2025.0 reciprocal endpoint titer Interval 1.0 to 18225.0	1.0 reciprocal endpoint titer Interval 1.0 to 18225.0

SECONDARY outcome

Timeframe: Baseline; Week 15 and Week 36

Assessment of cellular immune activity occurred via the application of the Interferon-γ enzyme-linked immunosorbent spot (IFN-γ ELISpot). Peripheral blood mononuclear cells (PBMCs) isolated from whole blood sample were used for analysis.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=116 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=54 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E6: Baseline	0.83 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 40.0	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 16.7
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E6: Change from Baseline at Week 15	13.33 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 446.7	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 13.3
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E6: Change from Baseline at Week 36	8.33 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 780.0	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 25.0
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E7: Baseline	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 53.3	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 83.3
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E7: Change from Baseline at Week 15	10.83 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 213.3	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 13.3
Change From Baseline in Interferon-Gamma Response Magnitude HPV-16 E7: Change from Baseline at Week 36	7.50 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 81.7	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 8.3
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E6: Baseline	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 10.0	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 20.0
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E6: Change from Baseline at Week 15	50.83 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 1910.0	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 6.7
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E6: Change from Baseline at Week 36	38.33 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 1031.7	0.0 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 23.3
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E7: Baseline	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 11.7	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 91.7
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E7: Change from Baseline at Week 15	14.17 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 251.7	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 20.0
Change From Baseline in Interferon-Gamma Response Magnitude HPV-18 E7: Change from Baseline at Week 36	10.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 508.3	0.00 spot forming units (SFU)/10^6 PBMC Interval 0.0 to 6.7

SECONDARY outcome

Timeframe: Baseline, Week 15

Assessment of cellular immune activity was measured using the application flow cytometry for the purposes of performing a Lytic Granule Loading Assay. The Lytic Granule Loading assay examines the following external cellular markers: CD3, CD4, CD8 (T cell identification), CD137, CD38 and CD69 (T cell activation markers) as well as PD-1 (exhaustion/activation marker). Here change from baseline in CD8+CD137+Perforin+, CD8+CD38+Perforin+ and CD8+CD69+Perforin+ are reported.

Outcome measures

Outcome measures
Measure	VGX-3100 + Electroporation (EP) n=114 Participants Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=58 Participants Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD38+Perforin+: Baseline	0.000 SFU/10^6 PBMC Interval 0.0 to 0.21	0.000 SFU/10^6 PBMC Interval 0.0 to 0.12
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD38+Perforin+: Change from Baseline at Week 15	0.011 SFU/10^6 PBMC Interval 0.0 to 0.23	0.000 SFU/10^6 PBMC Interval 0.0 to 0.1
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD69+Perforin+: Change from Baseline at Week 15	0.044 SFU/10^6 PBMC Interval 0.0 to 0.37	0.000 SFU/10^6 PBMC Interval 0.0 to 0.07
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD137+Perforin+: Baseline	0.004 SFU/10^6 PBMC Interval 0.0 to 0.15	0.001 SFU/10^6 PBMC Interval 0.0 to 0.22
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD137+Perforin+: Change from Baseline at Week 15	0.035 SFU/10^6 PBMC Interval 0.0 to 0.44	0.000 SFU/10^6 PBMC Interval 0.0 to 0.1
Change From Baseline in Flow Cytometry Response Magnitude CD8+CD69+Perforin+: Baseline	0.009 SFU/10^6 PBMC Interval 0.0 to 0.11	0.001 SFU/10^6 PBMC Interval 0.0 to 0.13

Adverse Events

VGX-3100 + Electroporation (EP)

Serious events: 13 serious events

Other events: 131 other events

Deaths: 1 deaths

Placebo + EP

Serious events: 6 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VGX-3100 + Electroporation (EP) n=136 participants at risk Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=62 participants at risk Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous Carcinoma of the Cervix	0.00% 0/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	1.6% 1/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma	2.2% 3/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	3.2% 2/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of the Cervix	3.7% 5/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Injury, poisoning and procedural complications Ligament Injury	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	1.6% 1/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	1.6% 1/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	1.6% 1/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Gastrointestinal disorders Diaphragmatic Hernia	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	1.6% 1/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Psychiatric disorders Bipolar Disorder	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Kidney Infection	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Pyelonephritis Acute	0.74% 1/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	0.00% 0/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.

Other adverse events

Additional Information

Study Director

Inovio Pharmaceuticals

Phone: 267-440-4237

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	VGX-3100 + Electroporation (EP) n=136 participants at risk Participants received three IM injections of 6 mg (in 1 mL) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.	Placebo + EP n=62 participants at risk Participants received three IM injections of 1 mL VGX-3100 matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
Gastrointestinal disorders Nausea	18.4% 25/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	17.7% 11/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Gastrointestinal disorders Abdominal Pain	5.9% 8/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	6.5% 4/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Pain	77.2% 105/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	79.0% 49/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Fatigue	29.4% 40/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	29.0% 18/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Pruritus	25.0% 34/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	22.6% 14/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Erythema	24.3% 33/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	22.6% 14/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Swelling	20.6% 28/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	24.2% 15/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Bruising	10.3% 14/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	14.5% 9/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Injection Site Haematoma	5.9% 8/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	9.7% 6/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
General disorders Malaise	6.6% 9/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	8.1% 5/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Nasopharyngitis	9.6% 13/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	6.5% 4/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Vaginitis Bacterial	6.6% 9/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	6.5% 4/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Vulvovaginal Candidiasis	6.6% 9/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	4.8% 3/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Infections and infestations Urinary Tract Infection	5.1% 7/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	6.5% 4/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Myalgia	20.6% 28/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	22.6% 14/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	9.6% 13/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	9.7% 6/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.
Nervous system disorders Headache	33.8% 46/136 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.	30.6% 19/62 • From baseline up to Week 88 Safety set included all participants who received at least one dose of clinical trial treatment. One participant received mixed treatment and was excluded from the safety analysis.