Phase
Condition
Cervical Dysplasia
Precancerous Condition
Lung Cancer
Treatment
CELLECTRA™-5PSP
VGX-3100
Matched Placebo
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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 Committeefor diagnosis scheduled to be collected within 10 weeks prior to anticipated date offirst dose of study drug
Confirmed histologic evidence of cervical HSIL at screening
Must be judged by Investigator to be an appropriate candidate for theprotocol-specified procedure required at Week 36
With respect to their reproductive capacity must be post-menopausal or surgicallysterile 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
Exclusion Criteria:
Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar,vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologicspecimen at screening
Cervical lesion(s) that cannot be fully visualized on colposcopy
History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, orinsufficient 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 orcondition which, in the judgment of the investigator, would jeopardize the safety ofthe participant, interfere with study assessments or endpoint evaluation, orotherwise impact the validity of the study results
Presence of acute or chronic bleeding or clotting disorder that would contraindicateIM injections, or use of blood thinners within 2 weeks of Day 0
Participation in an interventional study with an investigational compound or devicewithin 30 days of signing informed consent
Less than two acceptable sites available for IM injection
Study Design
Connect with a study center
Instituto de Ginecología
Rosario, Santa Fe S2000PBB
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, C1181ACH
ArgentinaSite Not Available
DIM Clinica Privada
Ramos Mejía, B1704ETD
ArgentinaSite Not Available
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
Salvador, Bahia 40420-000
BrazilSite Not Available
Hospital das Clinicas de Goiânia
Goiânia, Goiás 74605-050
BrazilSite Not Available
Hospital Erasto Gaertner
Curitiba, Paraná 80530-010
BrazilSite Not Available
Hospital Amaral Carvalho
Jaú, São Paulo 17210-120
BrazilSite Not Available
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirao Preto, São Paulo 14048-900
BrazilSite Not Available
Pärnu Hospital
Pärnu, Pärnumaa EE-80010
EstoniaSite Not Available
East Tallinn Central Hospital Womens Clinic
Tallinn, 10119
EstoniaSite Not Available
Tartu University Hospital
Tartu, 51014
EstoniaSite Not Available
HUS Naistentaudit ja synnytykset
Helsinki, Uusimaa FI-00290
FinlandSite Not Available
Northern Savo Hospital District Muncipal Federation
Kuopio, FI-70210
FinlandSite Not Available
Vilnius District Central Outpatient Clinic
Vilnius, LT-01117
LithuaniaSite Not Available
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08661
LithuaniaSite Not Available
Niepubliczny Zakład Opieki Zdrowotnej Profimed
Lublin, Lubelskie 20-880
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lubelskie 20-880
PolandSite Not Available
Centrum Medyczne Angelius Provita
Śląskie, 40-611
PolandSite Not Available
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras, 00935
Puerto RicoSite Not Available
Puerto Rico Translational Research Center (PRTRC)
San Juan, 00935
Puerto RicoSite Not Available
Lynette Reynders Private Practice
Centurion, Gauteng 0157
South AfricaSite Not Available
University of Cape Town
Cape Town, Western Cape 7925
South AfricaSite Not Available
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid, 28009
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
SpainSite Not Available
Mesa Obstetricians and Gynecologist
Phoenix, Arizona 85014
United StatesSite Not Available
Visions Clinical Research- Tucson
Tucson, Arizona 85712
United StatesSite Not Available
Nuvance Health
Danbury, Connecticut 06810
United StatesSite Not Available
Christiana Care Health System
Newark, Delaware 19713
United StatesSite Not Available
Women's Medical Research Group
Clearwater, Florida 33759
United StatesSite Not Available
Altus Research
Lake Worth, Florida 33461
United StatesSite Not Available
Salom and Tangir LLC
Miramar, Florida 33027
United StatesSite Not Available
Precision Clinical Research, LLC
Sunrise, Florida 33351
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Affinity Clinical Research Institute
Oak Brook, Illinois 60523
United StatesSite Not Available
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana 70072
United StatesSite Not Available
Unified Women's Clinical Research - Hagerstown
Hagerstown, Maryland 21740
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan 48604
United StatesSite Not Available
Meridian Clinical Research Norfolk
Norfolk, Nebraska 68701
United StatesSite Not Available
New Jersey Medical School
Newark, New Jersey 07103
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10583
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Suffolk Obstetrics and Gynecology
Port Jefferson, New York 11777
United StatesSite Not Available
Unified Women's Clinical Research - Greensboro
Greensboro, North Carolina 27408
United StatesSite Not Available
Unified Women's Clinical Research - Morehead City
Morehead City, North Carolina 28557
United StatesSite Not Available
Lyndhurst Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
ClinOhio Research Services
Columbus, Ohio 43213
United StatesSite Not Available
Obstetrics & Gynecology Associates, Inc.
Fairfield, Ohio 45014
United StatesSite Not Available
Frontier Clinical Research-Smithfield
Smithfield, Pennsylvania 15478
United StatesSite Not Available
Venus Gynecology, LLC
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Women's Physician Group Suite 203
Memphis, Tennessee 38119
United StatesSite Not Available
Storks Research
Sugar Land, Texas 77479
United StatesSite Not Available
Group For Women - Tidewater Clinical Research Inc.
Virginia Beach, Virginia 23456
United StatesSite Not Available
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