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REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

NCT03721978•Inovio Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women aged 18 years and above
•Confirmed cervical infection with HPV types 16 and/or 18 at screening
•Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
•Confirmed histologic evidence of cervical HSIL at screening
•Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
•With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
•Normal screening electrocardiogram (ECG)

Exclusion Criteria

•Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
•Cervical lesion(s) that cannot be fully visualized on colposcopy
•History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
•Treatment for cervical HSIL within 4 weeks prior to screening
•Pregnant, breastfeeding or considering becoming pregnant during the study
•History of previous therapeutic HPV vaccination
•Immunosuppression as a result of underlying illness or treatment
•Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
•Receipt of any non-study, live vaccine within 4 weeks of Day 0
•Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
+3 more criteria

Locations (53)

Visions Clinical Research- Tucson

Tucson, Arizona, United States

Nuvance Health

Danbury, Connecticut, United States

Christiana Care Health System

Newark, Delaware, United States

Altus Research

Lake Worth, Florida, United States

Salom and Tangir LLC

Miramar, Florida, United States

Precision Clinical Research, LLC

Sunrise, Florida, United States

Augusta University

Augusta, Georgia, United States

Affinity Clinical Research Institute

Oak Brook, Illinois, United States

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, United States

Unified Women's Clinical Research - Hagerstown

Hagerstown, Maryland, United States

Key Dates

Start Date

February 28, 2019

Primary Completion Date

August 23, 2022

Completion Date

September 15, 2022

Last Updated

October 17, 2024

Enrollment

203

ACTUAL participants

Conditions

Cervical DysplasiaCervical High Grade Squamous Intraepithelial LesionHSIL

Interventions

VGX-3100

BIOLOGICAL

Matched Placebo

BIOLOGICAL

CELLECTRA™-5PSP

DEVICE

Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

NCT07175662

High-grade Squamous Intraepithelial Lesion (HSIL)

View study

RECRUITINGNA

Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

NCT05606133

Cervical DysplasiaCervical Cancer

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

Inclusion Criteria

Exclusion Criteria

Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

Circulating Human Papilloma Virus (HPV) DNA for the Screening and Surveillance of Gynecologic Cancers

A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL

Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod

Large Loop Excision of the Transformation Zone (LLETZ) with Vs Without IntraOperative Application of Lugol's Iodine

Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples