A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 (HPV-003)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01304524
First received: February 16, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Biological: VGX 3100
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: 36 Weeks ] [ Designated as safety issue: No ]
    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 and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit.


Estimated Enrollment: 148
Study Start Date: April 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VGX 3100 Biological: VGX 3100
1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
Placebo Comparator: Placebo Biological: Placebo
1ml of placebo delivered IM followed by electroporation at Day 0, week 4 and week 12.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; lesions in ≤ 3 cervical quadrants (4 quadrant disease where the lesion occupies less than 50% of each quadrant will be considered for inclusion);
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304524

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85015
Tucson, Arizona, United States, 85721
United States, California
Colton, California, United States, 92324
La Mesa, California, United States, 91942
Los Angeles, California, United States, 90036
United States, Colorado
Lakewood, Colorado, United States, 80228
United States, Florida
Boynton Beach, Florida, United States, 33472
Ft. Lauderdale, Florida, United States, 33316
Sarasota, Florida, United States, 34231
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Michigan
Saginaw, Michigan, United States, 48604
United States, Montana
Missoula, Montana, United States, 59808
United States, New York
Bronx, New York, United States, 10467
Port Jefferson, New York, United States, 11777
United States, North Carolina
Raleigh, North Carolina, United States, 27607
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Columbus, Ohio, United States, 43231
United States, Oklahoma
Oklahoma city, Oklahoma, United States, 73117
United States, Oregon
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19122
United States, South Carolina
Mrytle Beach, South Carolina, United States, 29572
United States, Utah
Murray, Utah, United States, 84107
Pleasant Grove, Utah, United States, 84062
Sandy, Utah, United States, 84070
United States, Virginia
Richmond, Virginia, United States, 23233
United States, Washington
Renton, Washington, United States, 98055
Spokane, Washington, United States, 99207
Australia
Victoria, Australia, 3052
Canada, Quebec
Montreal, Quebec, Canada, H3A 1A1
Canada
Vancouver B.C., Canada, V5Z-1M9
Estonia
Tallinn, Estonia
Tartu, Estonia
Georgia
Batumi, Georgia, 6400
Tbilisi, Georgia
India
Bangalore, Karnataka, India, 560017
Jaipur, Rajasthan, India, 302017
Kolkata, India
New Delhi, India
Pune, India, 411043
Korea, Republic of
Seoul, Korea, Republic of
Puerto Rico
San Juan, Puerto Rico, 00936
South Africa
Bloemfontein, South Africa, 9301
Cape Town, South Africa, 7925
Sponsors and Collaborators
Inovio Pharmaceuticals
Investigators
Principal Investigator: Cornelia Trimble, MD Johns Hopkins University
Principal Investigator: Robert L Parker, Jr., MD Lyndhurst Gynecologic Associates
Principal Investigator: Guillermo Valenzuela, MD Arrowhead Regional Medical Center
  More Information

No publications provided

Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01304524     History of Changes
Other Study ID Numbers: HPV-003
Study First Received: February 16, 2011
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Inovio Pharmaceuticals:
CIN 2/3 or CIN 3
Cervical cancer
Papillomavirus

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 18, 2014