REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
NCT ID: NCT03721978
Last Updated: 2024-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
203 participants
INTERVENTIONAL
2019-02-28
2022-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VGX-3100 + EP
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.
VGX-3100
1 milliliter (mL) VGX-3100 injected IM.
CELLECTRA™-5PSP
CELLECTRA™-5PSP used for EP following IM injection of VGX 3100.
Matched Placebo + EP
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.
Matched Placebo
1 mL of matched Placebo injected IM.
CELLECTRA™-5PSP
CELLECTRA™-5PSP used for EP following IM injection of VGX 3100.
Interventions
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VGX-3100
1 milliliter (mL) VGX-3100 injected IM.
Matched Placebo
1 mL of matched Placebo injected IM.
CELLECTRA™-5PSP
CELLECTRA™-5PSP used for EP following IM injection of VGX 3100.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
* Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
* Less than two acceptable sites available for IM injection
18 Years
FEMALE
No
Sponsors
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Inovio Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jeffrey Skolnik, MD
Role: STUDY_DIRECTOR
Inovio Pharmaceuticals
Locations
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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
Boston Medical Center
Boston, Massachusetts, United States
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, United States
Meridian Clinical Research Norfolk
Norfolk, Nebraska, United States
New Jersey Medical School
Newark, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Suffolk Obstetrics and Gynecology
Port Jefferson, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Unified Women's Clinical Research - Greensboro
Greensboro, North Carolina, United States
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
ClinOhio Research Services
Columbus, Ohio, United States
Obstetrics & Gynecology Associates, Inc.
Fairfield, Ohio, United States
Frontier Clinical Research-Smithfield
Smithfield, Pennsylvania, United States
Venus Gynecology, LLC
Myrtle Beach, South Carolina, United States
Women's Physician Group Suite 203
Memphis, Tennessee, United States
Storks Research
Sugar Land, Texas, United States
Group For Women - Tidewater Clinical Research Inc.
Virginia Beach, Virginia, United States
Instituto de Ginecología
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
DIM Clinica Privada
Ramos Mejía, , Argentina
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas de Goiânia
Goiânia, Goiás, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
Pärnu Hospital
Pärnu, Pärnumaa, Estonia
East Tallinn Central Hospital Womens Clinic
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
HUS Naistentaudit ja synnytykset
Helsinki, Uusimaa, Finland
Northern Savo Hospital District Muncipal Federation
Kuopio, , Finland
Vilnius District Central Outpatient Clinic
Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Niepubliczny Zakład Opieki Zdrowotnej Profimed
Lublin, Lublin Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Angelius Provita
Śląskie, , Poland
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras, , Puerto Rico
Lynette Reynders Private Practice
Centurion, Gauteng, South Africa
University of Cape Town
Cape Town, Western Cape, South Africa
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-004114-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HPV-303
Identifier Type: -
Identifier Source: org_study_id
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