REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
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.
Timeline
- Start
- 2017-06-28
- Primary completion
- 2020-07-08
- Completion
- 2021-04-06
Outcome
Met primary endpoint
registry analysis (superiority test); VGX-3100 + Electroporation (EP) vs Placebo + EP; p = 0.029 NCT03185013 ↗
release “today announced it met primary and secondary endpoints among all evaluable subjects for the REVEAL 1 trial.” inovio.com ↗
release “INOVIO's lead candidate VGX-3100 met primary and secondary endpoints for all evaluable subjects in REVEAL 1” inovio.com ↗
release “REVEAL1（NCT03185013）的结果，共入组201人，有8名受试者退出，在接受统计的193名CIN2/3受试者中，疫苗接种组病变完全消退同时HPV病毒清除率的比例是23.7％（31/131），而安慰剂组是11.3％（7/62）（差异12.4％;95％置信区间为0.4％至22.5％;P=0.022)，具有统计学意义，达到了病变消退和HPV16/18病毒清除的主要终点” aeonvital.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIZALIMOGENE RALAPLASMID | Vaccine | 6 mg | Intramuscular |