Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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 appear to be well tolerated in humans. Therefore, we have developed our DNA vaccine, VGX-3100, to include plasmids targeting E6 and E7 proteins of both HPV subtypes 16 and 18. We have chosen to deliver our candidate vaccines via electroporation (EP) using the CELLECTRA™ constant current device to deliver a small electric charge following intramuscular (IM) injection, since animal studies have shown that this delivery method increases the immune response to our DNA vaccine leading to a decrease in the size of tumors caused by HPV 16 and 18. The vaccine is proposed to be given to patients with a history of CIN 2 and 3 that have been treated by surgery. We will determine which dose the DNA vaccine will be the best tolerated and elicit the strongest immune response.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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