Phase 3
N=201
REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
Cervical Dysplasia · Cervical High Grade Squamous Intraepithelial Lesion · HSIL
Bottom Line
View on ClinicalTrials.gov: NCT03185013 ↗Enrolled (actual)
201
Serious AEs
9.6%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples — 22.5; 11.1 percentage of participants — p=0.029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VGX-3100 (Biological); Placebo (Biological); Electroporation (EP) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Inovio Pharmaceuticals
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples |
22.5; 11.1 | 0.029 sig |
| SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study |
131; 61; 13; 6 | — |
| SECONDARY Percentage of Participants With No Evidence of Cervical HSIL on Histology |
31.9; 19.0 | — |
| SECONDARY Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing |
34.1; 15.9 | — |
| SECONDARY Percentage of Participants With No Evidence of LSIL or HSIL on Histology |
24.6; 11.1 | — |
| SECONDARY Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18 |
18.1; 6.3 | — |
| SECONDARY Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma |
84.1; 85.7 | — |
| SECONDARY Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations |
20.3; 9.5 | — |
| SECONDARY Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations |
225.0; 1.0; 1.0; 1.0; 2025.0; 1.0 | — |
| SECONDARY Change From Baseline in Interferon-Gamma Response Magnitude |
0.83; 0.00; 13.33; 0.00; 8.33; 0.00 | — |
| SECONDARY Change From Baseline in Flow Cytometry Response Magnitude |
0.004; 0.001; 0.035; 0.000; 0.000; 0.000 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03185013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.