drugset / Trial / NCT07454915
PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this Phase 2 study is to compare the effects of administering the PVX4 combination device biologic product (pBI-4 DNA vaccine via electroporation-mediated intramuscular delivery with the TriGrid™ Delivery System) in patients with biopsy-confirmed, human papilloma virus (HPV) 16-associated high grade cervical intraepithelial neoplasia (CIN2/3) as compared to the administration of placebo.
Timeline
- Start
- 2026-04-01
- Primary completion
- 2027-12
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pBI-4 | Vaccine | 1 mg | Intramuscular |