A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix

Who is this study for? Patients with Cervical Dysplasia
What treatments are being studied? CELLECTRA™-5PSP
Status: Completed
Location: See all (53) locations...
Intervention Type: Device, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

HPV-303 is a prospective, randomized, double-blind, placebo-controlled 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 human papillomavirus (HPV-16) and/or HPV-18.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 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)

Locations
United States
Arizona
Visions Clinical Research- Tucson
Tucson
Connecticut
Nuvance Health
Danbury
Delaware
Christiana Care Health System
Newark
Florida
Altus Research
Lake Worth
Salom and Tangir LLC
Miramar
Precision Clinical Research, LLC
Sunrise
Georgia
Augusta University
Augusta
Illinois
Affinity Clinical Research Institute
Oak Brook
Louisiana
Praetorian Pharmaceutical Research, LLC
Marrero
Massachusetts
Boston Medical Center
Boston
Maryland
Unified Women's Clinical Research - Hagerstown
Hagerstown
Michigan
Saginaw Valley Medical Research Group LLC
Saginaw
North Carolina
Unified Women's Clinical Research - Greensboro
Greensboro
Unified Women's Clinical Research - Morehead City
Morehead City
Lyndhurst Clinical Research
Winston-salem
Nebraska
Meridian Clinical Research Norfolk
Norfolk
New Jersey
New Jersey Medical School
Newark
New York
Montefiore Medical Center
Bronx
Columbia University Medical Center
New York
Suffolk Obstetrics and Gynecology
Port Jefferson
Ohio
ClinOhio Research Services
Columbus
Obstetrics & Gynecology Associates, Inc.
Fairfield
Pennsylvania
Frontier Clinical Research-Smithfield
Smithfield
South Carolina
Venus Gynecology, LLC
Myrtle Beach
Tennessee
Women's Physician Group Suite 203
Memphis
Texas
Storks Research
Sugar Land
Virginia
Group For Women - Tidewater Clinical Research Inc.
Virginia Beach
Other Locations
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma De Buenos Aires
DIM Clinica Privada
Ramos Mejía
Instituto de Ginecología
Rosario
Brazil
Hospital Erasto Gaertner
Curitiba
Hospital das Clinicas de Goiânia
Goiânia
Hospital Amaral Carvalho
Jaú
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirao Preto
Associação Obras Sociais Irmã Dulce Hospital Santo Antônio
Salvador
Estonia
Pärnu Hospital
Pärnu
East Tallinn Central Hospital Womens Clinic
Tallinn
Tartu University Hospital
Tartu
Finland
HUS Naistentaudit ja synnytykset
Helsinki
Northern Savo Hospital District Muncipal Federation
Kuopio
Lithuania
Vilnius District Central Outpatient Clinic
Vilnius
Vilnius University Hospital Santaros Klinikos
Vilnius
Poland
Niepubliczny Zakład Opieki Zdrowotnej Profimed
Lublin
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin
Centrum Medyczne Angelius Provita
Śląskie
Puerto Rico
Puerto Rico Translational Research Center (PRTRC)
Rio Piedras
South Africa
University of Cape Town
Cape Town
Lynette Reynders Private Practice
Centurion
Spain
Hospital Universitario de Bellvitge
L'hospitalet De Llobregat
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Clinico Universitario de Valencia
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Time Frame
Start Date: 2019-02-28
Completion Date: 2022-09-15
Participants
Target number of participants: 203
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Inovio Pharmaceuticals

This content was sourced from clinicaltrials.gov