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DNA Vaccine

VGX-3100 for Cervical Intraepithelial Lesion

Phase 3
Waitlist Available
Research Sponsored by Inovio Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 15 and 36
Awards & highlights

Study Summary

This study is evaluating whether a combination of two treatments may help treat cervical cancer.

Eligible Conditions
  • Cervical Dysplasia
  • Cervical Intraepithelial Lesion
  • Squamous Intraepithelial Lesion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 15 and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 15 and 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor Markers
Secondary outcome measures
Histocompatibility Antigens Class II
Among Baseline Biomarker-Positive Women and All Women Interferon-gamma Response Magnitudes at Baseline, Weeks 15 and 36
Among Baseline Biomarker-Positive Women and All Women Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Weeks 15 and 36
+7 more

Side effects data

From 2021 Phase 3 trial • 201 Patients • NCT03185013
77%
Injection Site Pain
34%
Headache
29%
Fatigue
25%
Injection Site Pruritus
24%
Injection Site Erythema
21%
Injection Site Swelling
21%
Myalgia
18%
Nausea
10%
Arthralgia
10%
Injection Site Bruising
10%
Nasopharyngitis
7%
Malaise
7%
Vaginitis Bacterial
7%
Vulvovaginal Candidiasis
6%
Abdominal Pain
6%
Injection Site Haematoma
5%
Urinary Tract Infection
4%
Squamous Cell Carcinoma of the Cervix
2%
Cervix Carcinoma
1%
Diaphragmatic Hernia
1%
Ligament Injury
1%
Pyelonephritis Acute
1%
Pulmonary Embolism
1%
Bipolar Disorder
1%
Kidney Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
VGX-3100 + Electroporation (EP)
Placebo + EP

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VGX-3100 + EPExperimental Treatment2 Interventions
IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
Group II: Placebo + EPPlacebo Group2 Interventions
IM injections with matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VGX-3100
2017
Completed Phase 3
~500
CELLECTRA™-5PSP
2019
Completed Phase 3
~210

Find a Location

Who is running the clinical trial?

Inovio PharmaceuticalsLead Sponsor
53 Previous Clinical Trials
4,636 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
491 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What site did they apply to?
Women's Physician Group Suite 203
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
2019. "REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03721978.
~34 spots leftby Apr 2025
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