18 and older, female only, with Cervical Dysplasia or Cervical High Grade Squamous Intraepithelial Lesion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants With No Histologic Evidence of Cervical HSIL on Histology Sample and No Evidence of HPV-16 and/or HPV-18 in Cervical SamplesPrimary· At Week 36
Baseline biomarker-positive participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at Week 36, and participants who did not have unscheduled excision or biopsy sample 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™. The efficacy time frame is defined by a biopsy or surgical excision at an
Group
Value
95% CI
VGX-3100 + EP
28.6
Matched Placebo + EP
0
Baseline Biomarker-positive Participants for Safety Population: Number of Participants With Any Local and Systemic Adverse Events (AEs)Secondary· From Baseline to Week 40
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 the pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as AEs. Nausea, fatigue, injection site bruising, injection site erythema, injection site haematoma, injection site induration, injection site
Nausea
Group
Value
95% CI
VGX-3100 + EP
6
Matched Placebo + EP
0
Fatigue
Group
Value
95% CI
VGX-3100 + EP
10
Matched Placebo + EP
2
Injection Site Bruising
Group
Value
95% CI
VGX-3100 + EP
7
Matched Placebo + EP
1
Injection Site Erythema
Group
Value
95% CI
VGX-3100 + EP
4
Matched Placebo + EP
2
Injection Site Haematoma
Group
Value
95% CI
VGX-3100 + EP
1
Matched Placebo + EP
0
Injection Site Induration
Group
Value
95% CI
VGX-3100 + EP
1
Matched Placebo + EP
0
Injection Site Pain
Group
Value
95% CI
VGX-3100 + EP
19
Matched Placebo + EP
4
Injection Site Pruritus
Group
Value
95% CI
VGX-3100 + EP
7
Matched Placebo + EP
2
Safety Population: Number of Participants With Local and Systemic AEsSecondary· From Baseline to Week 40
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 the pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as AEs. Nausea, chills, fatigue, injection site bruising, injection site erythema, injection site haematoma, injection site haemorrhage, inject
Nausea
Group
Value
95% CI
VGX-3100 + EP
36
Matched Placebo + EP
17
Mixed Treatment
0
Chills
Group
Value
95% CI
VGX-3100 + EP
2
Matched Placebo + EP
1
Mixed Treatment
0
Fatigue
Group
Value
95% CI
VGX-3100 + EP
56
Matched Placebo + EP
33
Mixed Treatment
1
Injection Site Bruising
Group
Value
95% CI
VGX-3100 + EP
21
Matched Placebo + EP
11
Mixed Treatment
0
Injection Site Erythema
Group
Value
95% CI
VGX-3100 + EP
36
Matched Placebo + EP
15
Mixed Treatment
0
Injection Site Haematoma
Group
Value
95% CI
VGX-3100 + EP
10
Matched Placebo + EP
7
Mixed Treatment
0
Injection Site Haemorrhage
Group
Value
95% CI
VGX-3100 + EP
1
Matched Placebo + EP
0
Mixed Treatment
0
Injection Site Induration
Group
Value
95% CI
VGX-3100 + EP
3
Matched Placebo + EP
0
Mixed Treatment
0
Baseline Biomarker-positive Participants for Safety Population: Number of Participants With Any Treatment Emergent AEs (TEAEs) and Serious TEAEs (Including Suspected Unexpected Serious Adverse Reaction [SUSAR] and Unexpected Adverse Device Effect [UADE])Secondary· From Baseline to Week 40
AE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. Serious AE (SAE) is any experience that suggested significant hazard, contraindication, side effect/precaution, \& fulfilled any of the following: fatal, life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant/required intervention to prevent other outcomes. TEAEs a
Participants with any TEAEs
Group
Value
95% CI
VGX-3100 + EP
20
Matched Placebo + EP
4
Participants with any Serious TEAEs
Group
Value
95% CI
VGX-3100 + EP
3
Matched Placebo + EP
0
Participants with SUSAR
Group
Value
95% CI
VGX-3100 + EP
0
Matched Placebo + EP
0
Participants with UADE
Group
Value
95% CI
VGX-3100 + EP
0
Matched Placebo + EP
0
Safety Population: Number of Participants With Any TEAEs and Serious TEAEs (Including SUSAR and UADE)Secondary· From Baseline to Week 40
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. SAE is any experience that suggested significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal, 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 other outcome
Participants with any TEAEs
Group
Value
95% CI
VGX-3100 + EP
131
Matched Placebo + EP
67
Mixed Treatment
1
Participants with any Serious TEAEs
Group
Value
95% CI
VGX-3100 + EP
9
Matched Placebo + EP
9
Mixed Treatment
0
Participants with SUSAR
Group
Value
95% CI
VGX-3100 + EP
0
Matched Placebo + EP
0
Mixed Treatment
0
Participants with UADE
Group
Value
95% CI
VGX-3100 + EP
0
Matched Placebo + EP
0
Mixed Treatment
0
ITT Population: Percentage of Participants With No Histologic Evidence of Cervical HSIL on Histology Sample and No Evidence of HPV-16 and/or HPV-18 in Cervical SamplesSecondary· At Week 36
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at Week 36, and participants who did not have unscheduled excision or biopsy sample 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™. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days
Group
Value
95% CI
VGX-3100 + EP
27.6
Matched Placebo + EP
8.7
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants With No Histologic Evidence of Cervical HSIL on Histology SampleSecondary· At Week 36
Baseline biomarker-positive participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants who did not have unscheduled excision or biopsy sample 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. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines t
Group
Value
95% CI
VGX-3100 + EP
38.1
Matched Placebo + EP
25.0
ITT Population: Percentage of Participants With No Histologic Evidence of Cervical HSIL on Histology SampleSecondary· At Week 36
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL at Week 36 and participants who did not have unscheduled excision or biopsy sample 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. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines the histology endpoint.
Group
Value
95% CI
VGX-3100 + EP
34.3
Matched Placebo + EP
21.7
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV TestingSecondary· At Week 36
Baseline biomarker-positive participants with no evidence of HPV-16 and/or HPV-18 at Week 36 time frame and participants in whom 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™. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines the histology endpoint.
Group
Value
95% CI
VGX-3100 + EP
38.1
Matched Placebo + EP
0
ITT Population: Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV TestingSecondary· At Week 36
Participants with no evidence of HPV-16 and/or HPV-18 at Week 36 and participants who did not have unscheduled excision or biopsy sample 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™. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. The first tissue removal sample within the time frame determines the histology endpoint.
Group
Value
95% CI
VGX-3100 + EP
38.1
Matched Placebo + EP
10.1
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants With No Histologic Evidence of LSIL or HSIL on Histology SampleSecondary· At Week 36
Baseline biomarker-positive participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at Week 36 and participants who did not have unscheduled excision or biopsy sample obtained between the initial dose up to Week 36 were considered to be responders. No evidence of LSIL was defined as no evidence of cervical squamous intraepithelial neoplasia 1 (CIN1), CIN2, or CIN3 on biopsies or excisional treatment. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL. The efficacy time frame is defined by a biopsy or surgical excision at any time star
Group
Value
95% CI
VGX-3100 + EP
38.1
Matched Placebo + EP
25.0
ITT Population: Percentage of Participants With No Evidence of Histologic LSIL or HSIL on Histology SampleSecondary· At Week 36
Participants with no histologic evidence of cervical HSIL, squamous atypia, or LSIL at Week 36 and participants who did not have unscheduled excision or biopsy sample obtained between the initial dose up to Week 36 were considered to be responders. No evidence of LSIL was defined as no evidence of CIN1, CIN2, or CIN3 on biopsies or excisional treatment. No evidence of HSIL was defined by histology as negative, squamous atypia, or LSIL. The efficacy time frame is defined by a biopsy or surgical excision at any time starting from 14 days prior to the protocol-specified target date of Week 36. Th
Group
Value
95% CI
VGX-3100 + EP
32.1
Matched Placebo + EP
14.5
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline to Week 40.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
VGX-3100 + EP
Serious: 9/134 (7%)
Deaths: 0/134
Matched Placebo + EP
Serious: 9/67 (13%)
Deaths: 0/67
Mixed Treatment
Serious: 0/1 (0%)
Deaths: 0/1
Serious adverse events (7 terms)
Reaction
System
VGX-3100 + EP
Matched Placebo + EP
Mixed Treatment
Cervix carcinoma stage 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Squamous cell carcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Adenocarcinoma of the cervix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with human papillomavirus (HPV-16) and/or HPV-18.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03499795 — VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Relat
· Phase 2
· completed
NCT03180684 — Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV
· Phase 2
· completed
NCT03185013 — REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inovio Pharmaceuticals
Last refreshed: 17 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03721978.