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Trial record 1 of 1 for:    NCT01304524
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A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 (HPV-003)

This study has been completed.
Information provided by (Responsible Party):
Inovio Pharmaceuticals Identifier:
First received: February 16, 2011
Last updated: February 22, 2016
Last verified: February 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    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 ]
    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.

Enrollment: 167
Study Start Date: April 2011
Study Completion Date: January 2016
Primary Completion Date: May 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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01304524

  Show 43 Study Locations
Sponsors and Collaborators
Inovio Pharmaceuticals
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Inovio Pharmaceuticals Identifier: NCT01304524     History of Changes
Other Study ID Numbers: HPV-003
Study First Received: February 16, 2011
Last Updated: February 22, 2016

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

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on April 28, 2017