REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
NCT ID: NCT03185013
Last Updated: 2023-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2017-06-28
2021-04-06
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 three IM injections of 6 milligram (mg) (in 1 milliliter \[mL\]) VGX-3100 followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4, and Week 12.
VGX-3100
1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Electroporation (EP)
Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
Placebo + EP
Participants received three 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.
Placebo
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Electroporation (EP)
Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
Interventions
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VGX-3100
1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Placebo
1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
Electroporation (EP)
Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
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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Mesa Obstetricians and Gynecologist
Mesa, Arizona, United States
Women's Health Research
Scottsdale, Arizona, United States
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Women's Medical Research Group
Clearwater, Florida, United States
Altus Research
Lake Worth, Florida, United States
Salom and Tangir LLC
Miramar, Florida, United States
Comprehensive Clinical Trials LLC
West Palm Beach, Florida, United States
Augusta University
Augusta, Georgia, United States
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, 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
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina, United States
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina, United States
Chattanooga Medical Research Inc
Chattanooga, Tennessee, United States
Women's Physician Group
Memphis, Tennessee, United States
UAG Innovation Women Research, LLC
Houston, Texas, United States
Group For Women
Norfolk, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Instituto de Ginecología
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
DIM Clínica Privada
Ramos Mejía, , Argentina
Centre Hospitalier Universitaire Ambroise Paré
Mons, Hainaut, Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Pärnu Hospital
Pärnu, Pärnumaa, Estonia
East Tallinn Central Hospital Womens Clinic
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Kätilöopiston sairaala
Helsinki, , Finland
Lääkäriasema Cantti Oy
Kuopio, , Finland
Elisabeth Krankenhaus Essen GmbH
Essen, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Istituto Nazionale Dei Tumori
Milan, , Italy
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Vilnius District Central Outpatient Clinic
Vilnius, , Lithuania
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco, Mexico
Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
Lima, , Peru
Liga Peruana De Lucha Contra El Cancer
Lima, , Peru
Perpetual Succour Hospital
Cebu, , Philippines
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
Katowice, , Poland
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, , Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras, , Puerto Rico
MCM GYNPED, s.r.o.
Dubnica nad Váhom, , Slovakia
Univerzitna nemocnica Martin
Martin, , Slovakia
Lynette Reynders Private Practice
Centurion, Gauteng, South Africa
University of Cape Town
Cape Town, , South Africa
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Chulalongkorn University
Bangkok, , Thailand
Siriraj Hospital Mahidol University
Bangkok, , Thailand
Aberdeen Royal Infirmary - PPDS
Aberdeen, , United Kingdom
St Marys Hospital
London, , United Kingdom
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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2016-002761-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HPV-301
Identifier Type: -
Identifier Source: org_study_id
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