Your session is about to expire
← Back to Search
DNA Vaccine
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
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 week 15 and week 36
Awards & highlights
Pivotal Trial
Summary
This trial tests a treatment involving an injection followed by a special technique to help the medicine work better. It targets adult women with severe precancerous changes in the cervix caused by specific types of HPV. The goal is to boost the immune system to fight and remove these abnormal cells.
Eligible Conditions
- Cervical Dysplasia
- Cervical Intraepithelial Lesion
- Squamous Intraepithelial Lesion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 15 and week 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 15 and week 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 Samples
Secondary study objectives
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations
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 Testing
Baseline Biomarker-positive Participants for ITT Population: Percentage of Participants With No Evidence of LSIL or HSIL on Histology Sample and No Evidence of HPV-16 and/or HPV-18 by Type Specific HPV Testing
+20 moreSide effects data
From 2021 Phase 3 trial • 201 Patients • NCT0318501377%
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%
Pyelonephritis Acute
1%
Ligament Injury
1%
Pulmonary Embolism
1%
Bipolar Disorder
1%
Kidney Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
VGX-3100 + Electroporation (EP)
Placebo + EP
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: VGX-3100 + EPExperimental Treatment2 Interventions
Participants received 3 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.
Group II: Matched Placebo + EPPlacebo Group2 Interventions
Participants received 3 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.
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
4,602 Total Patients Enrolled
Jeffrey Skolnik, MDStudy DirectorInovio Pharmaceuticals
12 Previous Clinical Trials
491 Total Patients Enrolled