Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Inovio Pharmaceuticals
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
