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

  Show 43 Study Locations
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
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014