← Back to Search

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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 15 and week 36 for reporting.

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 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

Malaise

Vaginitis Bacterial

Vulvovaginal Candidiasis

Abdominal Pain

Injection Site Haematoma

Urinary Tract Infection

Squamous Cell Carcinoma of the Cervix

Cervix Carcinoma

Diaphragmatic Hernia

Pyelonephritis Acute

Ligament Injury

Pulmonary Embolism

Bipolar Disorder

Kidney Infection

100%

80%

60%

40%

20%

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