Health Condition 1: null- Cervical Intraepithelial Neoplasia Grade 2/3 or 3
Conditions
Interventions
Intervention1: VGX-3100 DNA Vaccine
: 6 mg dose of VGX-3100 in a 1 mL injection volume delivered IM followed by Electroporation at Day 0, Week 4 and Week 12.
Control Intervention1: Placebo (Sterile Wa
Sponsors
Inovio Pharmaceuticals Inc
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: a. Female subjects age 18-55 years; b. 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; c. 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 d. 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; e. 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); f. Able and willing to comply with all study procedures and voluntarily signs informed consent form
Exclusion criteria
Exclusion criteria: a. 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; b. Pregnancy or breastfeeding; c. 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; d. History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded); e. Positive serological test for hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or human immunodeficiency virus (HIV); f. Administration of any blood product within 3 months of enrollment; g. Administration of any licensed vaccine within 2 weeks of enrollment (4 weeks for measles vaccine); h. Participation in a study with an investigational compound or device within 30 days of signing informed consent; i. Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White); j. History of seizures (unless seizure free for 5 years); k. Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads; l. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; m. 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 n. Any other conditions judged by the investigator that would limit the evaluation of a subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with histopathological regression of cervical lesions to CIN 1 or Less as a measure of efficacy. Timepoint: 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 36 weeks | — |
Countries
Australia, Canada, Estonia, Georgia, India, South Africa, United States of America
Contacts
Public ContactDr Shariq Anwar
Max Neeman International
Outcome results
None listed