Status:
COMPLETED
Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3
Lead Sponsor:
Inovio Pharmaceuticals
Conditions:
Papillomavirus Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
DNA vaccines, which are small pieces of DNA also known as plasmids, have several advantages over traditional vaccines such as live attenuated virus and recombinant protein-based vaccines. DNA vaccines...
Eligibility Criteria
Inclusion
- Written informed consent in accordance with institutional guidelines;
- Female 18-45 years of age;
- Post surgical (including LEEP and conization) or ablative treatment and a diagnosis of CIN 2 or 3, while under physician care as per ASCCP guidelines (Appendix D);
- Normal ECG and normal laboratory values as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix C) for CBC, CPK, SMA-12 and urinalysis evaluations done up to 30 days prior to administration of study treatment;
- Body mass index (BMI) ≤30 kg/m2;
- Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) from enrollment to 3 months after the last injection (\~6 months);
- Able and willing to comply with all study procedures.
Exclusion
- Active infection with herpes simplex virus (HSV);
- Positive serological test for HIV virus, hepatitis C virus or Hepatitis B virus surface antigen (HBsAg);
- Pregnant or breastfeeding subjects;
- Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 1 of treatment;;
- Administration of any blood product within 3 months of enrollment;
- Administration of any vaccine within 6 weeks of enrollment;
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent;
- Metal implants at the site of injection;
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00685412
Start Date
May 1 2008
End Date
March 1 2011
Last Update
September 13 2017
Active Locations (4)
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1
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
2
Laurel Highlands, OB/GYN, P.C.
Hopwood, Pennsylvania, United States, 15445
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909