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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cervical Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT01304524

Run by

Inovio Pharmaceuticals

People needed

167

Starts

2011-04-01

Expected to finish

2015-04-01

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Colton, California, United States
• Study site — La Mesa, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Saginaw, Michigan, United States
• Study site — Missoula, Montana, United States
• Study site — Port Jefferson, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Eugene, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Myrtle Beach, South Carolina, United States
• Study site — Murray, Utah, United States
• Study site — Pleasant Grove, Utah, United States
• Study site — Sandy City, Utah, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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