Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-07
Trial Details
NCT Number NCT07454915
Lead Sponsor PapiVax Biotech, Inc.
Conditions Cervical Intraepithelial Neoplasia Grade 2/3, Human Papilloma Virus Infection Type 16
Enrollment 138 participants
Start Date 2026-04-01
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-06