Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VGX-3100 + EP
IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
  • Biological: VGX-3100
    1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
  • Device: CELLECTRA™-5PSP
    CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Placebo Comparator
Placebo + EP
IM injections with matching placebo followed by EP using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
  • Biological: Placebo
    1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
  • Device: CELLECTRA™-5PSP
    CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Inovio Pharmaceuticals

Study Contact

Inovio Call Center
267-440-4237
clinical.trials@inovio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.