Phase
Condition
Cervical Intraepithelial Neoplasia
Cervical Dysplasia
Lung Cancer
Treatment
VGX-3100
Placebo
Electroporation (EP)
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 Committee fordiagnosis scheduled to be collected within 10 weeks prior to anticipated date of firstdose 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% peryear 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 or conditionwhich, in the judgment of the investigator, would jeopardize the safety of theparticipant, interfere with study assessments or endpoint evaluation, or otherwiseimpact 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
Centro de Diagnostico Urologico SRL
Buenos Aires, Ciudad Autónoma De BuenosAires C1120AAT
ArgentinaSite Not Available
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 Clínica Privada
Ramos Mejía, B1704ETD
ArgentinaSite Not Available
UZ Antwerpen
Edegem, Antwerpen 2650
BelgiumSite Not Available
Centre Hospitalier Universitaire Ambroise Paré
Mons, Hainaut 7000
BelgiumSite Not Available
Ziekenhuis Oost-Limburg
Genk, Limburg 3600
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Clinique RSF
Quebec City, Quebec G1S 2L6
CanadaSite Not Available
Vseobecna fakultni nemocnice v Praze
Praha 2, Praha, Hlavní Mesto 128 08
CzechiaSite Not Available
Nemocnice Jihlava, prispevkova organizace
Jihlava, 586 33
CzechiaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, 775 20
CzechiaSite Not Available
Pärnu Hospital
Pärnu, Pärnumaa EE-80010
EstoniaSite Not Available
East Tallinn Central Hospital Womens Clinic
Tallin, 10119
EstoniaSite Not Available
Tartu University Hospital
Tartu, 51014
EstoniaSite Not Available
Kätilöopiston sairaala
Helsinki, 290
FinlandSite Not Available
HUS Naistentaudit ja synnytykset
Husu, 290
FinlandSite Not Available
Lääkäriasema Cantti Oy
Kuopio, FI-70110
FinlandSite Not Available
Elisabeth Krankenhaus Essen GmbH
Essen, 45138
GermanySite Not Available
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
GermanySite Not Available
Fondazione Policlinico Universitario A Gemelli
Roma, Lazio 00168
ItalySite Not Available
Istituto Europeo Di Oncologia
Milan, 20141
ItalySite Not Available
Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Vilnius District Central Outpatient Clinic
Vilnius, LT-01117
LithuaniaSite Not Available
Vilnius University Hospital Santaros Klinikos
Vilnius, LT- 08661
LithuaniaSite Not Available
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, Jalisco 44340
MexicoSite Not Available
Centro Integral Medico SJR S.C
San Juan Del Río, Querétaro 76800
MexicoSite Not Available
Liga Peruana De Lucha Contra El Cancer
Lima, 15084
PeruSite Not Available
Unidad de Ensayos Clinicos (UNIDEC) del Policlinico Universidad Nacional Mayor de San Marcos
Lima, 15083
PeruSite Not Available
Davao Doctors Hospital
Davao City, Davao Del Sur
PhilippinesSite Not Available
Perpetual Succour Hospital
Cebu, 6000
PhilippinesSite 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
Ginekologiczno-Polozniczy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznań, Wielkopolskie 60-535
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro
Aveiro, 3814-501
PortugalSite Not Available
Hospital de Braga
Braga, 4710-243
PortugalSite Not Available
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra, 3000-075
PortugalSite Not Available
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisboa, 1649-035
PortugalSite Not Available
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras, 00935
Puerto RicoSite Not Available
MCM GYNPED, s.r.o.
Dubnica Nad Váhom, 018 41
SlovakiaSite Not Available
Univerzitna nemocnica Martin
Martin, 036 59
SlovakiaSite Not Available
Lynette Reynders Private Practice
Centurion, Gauteng 157
South AfricaSite Not Available
University of Cape Town
Cape Town, 7925
South AfricaSite Not Available
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona 8907
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Regional Universitario de Malaga - Hospital Materno Infantil
Málaga, 29011
SpainSite Not Available
Chulalongkorn University
Bangkok, 10700
ThailandSite Not Available
Siriraj Hospital Mahidol University
Bangkok, 10700
ThailandSite Not Available
Aberdeen Royal Infirmary - PPDS
Aberdeen, AB25 7ZD
United KingdomSite Not Available
St Marys Hospital
London, W2 1NY
United KingdomSite Not Available
Coastal Clinical Research Inc
Mobile, Alabama 36608
United StatesSite Not Available
Mesa Obstetricians and Gynecologist
Mesa, Arizona 85209
United StatesSite Not Available
Women's Health Research
Phoenix, Arizona 85015
United StatesSite Not Available
Women's Health Research
Scottsdale, Arizona 85251
United StatesSite Not Available
Visions Clinical Research-Tucson
Tucson, Arizona 85712
United StatesSite Not Available
Mommy and Me Medical Group
Colton, California 92324
United StatesSite Not Available
Women's Medical Research Group
Clearwater, Florida 33759
United StatesSite Not Available
Unified Women's Clinical Research Gainesville
Gainesville, Florida 32605
United StatesSite Not Available
Hope Clinical Research LLC
Kissimmee, Florida 34741
United StatesSite Not Available
Altus Research
Lake Worth, Florida 33461
United StatesSite Not Available
Salom and Tangir LLC
Miramar, Florida 33461
United StatesSite Not Available
Comprehensive Clinical Trials LLC
West Palm Beach, Florida 33409
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
WR-Mount Vernon Clinical Research
Sandy Springs, Georgia 30328
United StatesSite Not Available
Hutchinson Clinic
Hutchinson, Kansas 67502-1131
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana 70072
United StatesSite Not Available
MedPharmics
Metairie, Louisiana 70006
United StatesSite Not Available
Continental Clinical Research Solutions LLC
Towson, Maryland 21204
United StatesSite Not Available
Beyer Research
Kalamazoo, Michigan 49009
United StatesSite Not Available
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan 48604
United StatesSite Not Available
Montana Medical Research
Missoula, Montana 59808
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
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
Carolina Women's Research and Wellness Center
Durham, North Carolina 27713
United StatesSite Not Available
Unified Women's Clinical Research Hickory
Hickory, North Carolina 28602
United StatesSite Not Available
Unified Women's Clinical Research Raleigh
Raleigh, North Carolina 27607-7514
United StatesSite Not Available
Lyndhurst Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Greenville Pharmaceutical Research, Inc.
Greenville, South Carolina 29615
United StatesSite Not Available
Magnolia Ob/Gyn Research Center, LLC
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
Chattanooga Medical Research Inc
Chattanooga, Tennessee 37404
United StatesSite Not Available
Women's Physician Group
Memphis, Tennessee 38104
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
UAG Innovation Women Research, LLC
Houston, Texas 77074
United StatesSite Not Available
MacArthur Obstetrics and Gynecology
Irving, Texas 75062
United StatesSite Not Available
Eastern Virginia Medical School
Norfolk, Virginia 23507
United StatesSite Not Available
Group For Women
Norfolk, Virginia 23502
United StatesSite Not Available
Multicare Health System
Covington, Washington 98042
United StatesSite Not Available
Valley Womens Clinic
Renton, Washington 98055
United StatesSite Not Available
North Spokane Women's Clinic
Spokane, Washington 99207
United StatesSite Not Available
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