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Brief Title: REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Official Title: Randomized Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL
Study ID: NCT03721978
Brief Summary: HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 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 HPV-16 and/or HPV-18.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Montefiore Medical Center, Bronx, New York, United States
Columbia University Medical Center, New York, New York, United States
Suffolk Obstetrics and Gynecology, Port Jefferson, 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, Argentina
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aires, , Argentina
DIM Clinica Privada, Ramos Mejía, , Argentina
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio, Salvador, 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, Ribeirao 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, Lubelskie, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, Lubelskie, 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
Name: Jeffrey Skolnik, MD
Affiliation: Inovio Pharmaceuticals
Role: STUDY_DIRECTOR