RecruitingPhase 2NCT07454915

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

Sponsor

PapiVax Biotech, Inc.

Enrollment

138 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PVX4 Combination Product and Placebo Control for people with cervical intraepithelial neoplasia grade 2/3 and human papilloma virus infection type 16. The study is currently recruiting participants at 10 locations. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPVX4 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)

OTHERPlacebo 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)

Locations(10)

Montefiore Medical Center

The Bronx, New York, United States

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, Taiwan, Taiwan

China Medical University Hospital

Taichung, Taiwan, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07454915

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