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

NCT07454915 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-05-06

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • PapiVax Biotech, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454915 on ClinicalTrials.gov