Study of Treatment for HPV16+ ASC-US or LSIL — PVX-6  

ASC-US Clinical Trial

Official title: Phase I Clinical Trial Assessing the Safety and Feasibility of Intramuscular pNGVL4aCRTE6E7L2 and TA-CIN Administration for the Treatment of Patients With Persistent HPV16+ ASC-US or LSIL

Status Recruiting

Clinical Trial Summary

Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine

Clinical Trial Description

Primary Objectives

1. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL.

2. To determine the appropriate intra-muscular injection dose of pNGVL4aCRTE6E7L2 DNA vaccine as determined by toxicity and immunogenicity for a subsequent phase II clinical trial.

3. To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine prime, TA-CIN protein vaccine boost in patients with persistent HPV16+ ASC-US/LSIL. ;

Related Conditions & MeSH terms

• ASC-US
• LSIL

• NCT number: NCT03913117
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Wendy Wu, MS
• Phone: +886 2 8226 8451
• Email: wendy@papivax.com.tw
• Status: Recruiting
• Phase: Phase 1
• Start date: July 10, 2023
• Completion date: December 30, 2024