Papillomavirus Infections
Conditions
Keywords
CIN 2 or 3, cervical cancer
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 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.
Interventions
BIOLOGICALVGX-3100
DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
Sponsors
Inovio Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of escalating doses of VGX-3100, administered by IM injection with EP to adult female subjects post surgical or ablative treatment of grade 2 or 3 CIN. | Through Month 4 |
Secondary
| Measure | Time frame |
|---|---|
| Humoral and cellular immune responses to VGX-3100 in blood samples obtained from study subjects after each dose of a 3-dose series of VGX-3100 containing 0.6, 2 or 6 mg of DNA/dose. | At end of study |
Countries
Puerto Rico, United States
Outcome results
None listed