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

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia
• Interventions: Biological: Placebo; Biological: VGX 3100; Device: CELLECTRA™-5P

• Registration Number: NCT01304524
• Lead Sponsor: Inovio Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-25
• Study Start: 2011-04
• Primary Completion: 2014-05
• Study Completion: 2015-04
• Disposition First Submitted: 2018-05-23
• Disposition First Submitted QC: 2018-05-23
• Disposition First Posted: 2018-05-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Placebo	CELLECTRA™-5P	-
VGX 3100	VGX 3100	-
VGX 3100	CELLECTRA™-5P	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.	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

Name	Time	Method
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	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.