Brief Title
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Official Title
A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
Brief Summary
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to
determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular
(IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women
with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL)
(cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human
papillomavirus (HPV) 16 and/or HPV-18.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Participants with No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples at Week 36
Secondary Outcome
Safety: Number of Participants with Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment and for the Duration of the Study
Condition
Cervical Dysplasia
Intervention
VGX-3100
Study Arms / Comparison Groups
VGX-3100 + EP
Description: IM injections with VGX-3100 followed by electroporation (EP) using the CELLECTRA™-5PSP device on Day 0, Week 4 and Week 12.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
201
Start Date
June 28, 2017
Completion Date
April 7, 2021
Primary Completion Date
July 8, 2020
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jeffrey Skolnik, MD, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT03185013
Organization ID
HPV-301
Secondary IDs
2016-002761-63
Responsible Party
Sponsor
Study Sponsor
Inovio Pharmaceuticals
Study Sponsor
Jeffrey Skolnik, MD, Study Director, Inovio Pharmaceuticals
Verification Date
December 2021