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NOT YET RECRUITING
NCT07454915
PHASE2

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

Sponsor: PapiVax Biotech, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2026-03-01

Completion Date

2028-06

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

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)

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 District, Taiwan, Taiwan