Status:
COMPLETED
Fourth Dose of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + EP in Adult Females Previously Vaccinated With Three Doses of VGX-3100
Lead Sponsor:
Inovio Pharmaceuticals
Conditions:
Human Papillomavirus (HPV)
Eligibility:
FEMALE
18-46 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;
- Successful enrollment in and completion of all study procedures and follow-up in study HPV-001.
- Female 18-46 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 C);
- Normal ECG and CPK, as judged by Grade 0-1 as per Toxicity Grading Scale for Healthy Adults (Appendix B) 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 study discharge;
- Able and willing to comply with all study procedures.
Exclusion
- Active infection with herpes simplex virus (HSV);
- Pregnant or breast feeding 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 other than VGX-3100 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 :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01188850
Start Date
July 1 2010
End Date
October 20 2011
Last Update
August 10 2018
Active Locations (3)
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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, 15904
3
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909