A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3
HPV-003
Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation With CELLECTRA-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 With Documented HPV 16 or 18.
1 other identifier
interventional
167
9 countries
43
Brief Summary
This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18 associated Cervical intraepithelial neoplasia grade 2/3 or 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2011
Typical duration for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedSeptember 7, 2018
September 1, 2018
3.1 years
February 16, 2011
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.
36 weeks
Secondary Outcomes (1)
Number of Participants with Virologically-proven Clearance of HPV 16 or 18 in Combination with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Secondary Measure of Efficacy
36 Weeks
Study Arms (2)
VGX 3100
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Eligibility Criteria
You may qualify if:
- Female subjects age 18-55 years;
- Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive cancer in any specimen;
- Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrollment and administration of study drug;
- Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);
- Able and willing to comply with all study procedures and voluntarily signs informed consent form
You may not qualify if:
- Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
- Pregnancy or breastfeeding
- Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site \[deltoid, upper arm\] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
- History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
- Positive serological test for hepatitis C virus or hepatitis B virus surface antigen(HBsAg) or human immunodeficiency virus (HIV)
- Administration of any blood product within 3 months of enrollment
- Administration of any licensed vaccine within 2 weeks of enrollment( 4weeks for measles vaccine)
- Participation in a study with an investigational compound or device within 30 days of signing informed consent;
- Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
- History of seizures (unless seizure free for 5 years);
- Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads; or any implantable leads;
- Active drug or alcohol use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements;
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
- Any other conditions judged by the investigator that would limit the evaluation of a subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Unknown Facility
Phoenix, Arizona, 85015, United States
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Tucson, Arizona, 85721, United States
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Colton, California, 92324, United States
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La Mesa, California, 91942, United States
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Los Angeles, California, 90036, United States
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Lakewood, Colorado, 80228, United States
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Boynton Beach, Florida, 33472, United States
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Fort Lauderdale, Florida, 33316, United States
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Sarasota, Florida, 34231, United States
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Baltimore, Maryland, 21205, United States
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Saginaw, Michigan, 48604, United States
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Missoula, Montana, 59808, United States
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Port Jefferson, New York, 11777, United States
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The Bronx, New York, 10467, United States
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Raleigh, North Carolina, 27607, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43231, United States
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Oklahoma City, Oklahoma, 73117, United States
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Eugene, Oregon, 97401, United States
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Philadelphia, Pennsylvania, 19122, United States
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Myrtle Beach, South Carolina, 29572, United States
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Murray, Utah, 84107, United States
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Pleasant Grove, Utah, 84062, United States
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Sandy City, Utah, 84070, United States
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Richmond, Virginia, 23233, United States
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Renton, Washington, 98055, United States
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Spokane, Washington, 99207, United States
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Victoria, 3052, Australia
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Montreal, Quebec, H3A 1A1, Canada
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Vancouver, V5Z-1M9, Canada
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Tallinn, Estonia
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Tartu, Estonia
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Batumi, 6400, Georgia
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Tbilisi, Georgia
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Bangalore, Karnataka, 560017, India
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Jaipur, Rajasthan, 302017, India
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Kolkata, India
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New Delhi, India
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Pune, 411043, India
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San Juan, 00936, Puerto Rico
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Bloemfontein, 9301, South Africa
Unknown Facility
Cape Town, 7925, South Africa
Unknown Facility
Seoul, South Korea
Related Publications (2)
Bhuyan PK, Dallas M, Kraynyak K, Herring T, Morrow M, Boyer J, Duff S, Kim J, Weiner DB. Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL. Hum Vaccin Immunother. 2021 May 4;17(5):1288-1293. doi: 10.1080/21645515.2020.1823778. Epub 2020 Nov 11.
PMID: 33175656DERIVEDTrimble CL, Morrow MP, Kraynyak KA, Shen X, Dallas M, Yan J, Edwards L, Parker RL, Denny L, Giffear M, Brown AS, Marcozzi-Pierce K, Shah D, Slager AM, Sylvester AJ, Khan A, Broderick KE, Juba RJ, Herring TA, Boyer J, Lee J, Sardesai NY, Weiner DB, Bagarazzi ML. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015 Nov 21;386(10008):2078-2088. doi: 10.1016/S0140-6736(15)00239-1. Epub 2015 Sep 17.
PMID: 26386540DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cornelia Trimble, MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Robert L Parker, Jr., MD
Lyndhurst Gynecologic Associates
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
February 25, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2014
Study Completion
April 1, 2015
Last Updated
September 7, 2018
Record last verified: 2018-09