REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
HPV-303 is a prospective, randomized, double-blind, placebo-controlled phase 3 study of
 VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with
 CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous
 intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3
 [CIN3]) of the cervix, associated with HPV-16 and/or HPV-18.
Inclusion Criteria:

 -  Women aged 18 years and above

 -  Confirmed cervical infection with HPV types 16 and/or 18 at screening

 -  Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for
 diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first
 dose of study drug

 -  Confirmed histologic evidence of cervical HSIL at screening

 -  Must be judged by Investigator to be an appropriate candidate for the
 protocol-specified procedure required at Week 36

 -  With respect to their reproductive capacity must be post-menopausal or surgically
 sterile or willing to use a contraceptive method with failure rate of less than 1% per
 year when used consistently and correctly from screening until Week 36

 -  Normal screening electrocardiogram (ECG)

 Exclusion Criteria:

 -  Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar,
 vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic
 specimen at screening

 -  Cervical lesion(s) that cannot be fully visualized on colposcopy

 -  History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or
 insufficient for diagnosis

 -  Treatment for cervical HSIL within 4 weeks prior to screening

 -  Pregnant, breastfeeding or considering becoming pregnant during the study

 -  History of previous therapeutic HPV vaccination

 -  Immunosuppression as a result of underlying illness or treatment

 -  Receipt of any non-study, non-live vaccine within 2 weeks of Day 0

 -  Receipt of any non-study, live vaccine within 4 weeks of Day 0

 -  Current or history of clinically significant, medically unstable disease or condition
 which, in the judgment of the investigator, would jeopardize the safety of the
 participant, interfere with study assessments or endpoint evaluation, or otherwise
 impact the validity of the study results

 -  Presence of acute or chronic bleeding or clotting disorder that would contraindicate
 IM injections, or use of blood thinners within 2 weeks of Day 0

 -  Participation in an interventional study with an investigational compound or device
 within 30 days of signing informed consent

 -  Less than two acceptable sites available for IM injection