NCT07454915

PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: PapiVax Biotech, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia Grade 2/3
• Human Papilloma Virus Infection Type 16

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PVX4 Combination Product	pBI-4 DNA vaccine (1.0 mg) administered by electroporation mediated intramuscular injection via the TriGrid Delivery System version 2.0 (TDS-IM v2.0)
OTHER	Placebo Control	0.9% Saline for injection (1.0 mL) administered by electroporation mediated intramuscular injection via the TriGrid Delivery System version 2.0 (TDS-IM v2.0)

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2026-03-06
• Last updated: 2026-03-09

Locations

10 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study