NCT03913117

Study of Treatment for HPV16+ ASC-US or LSIL

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• ASC-US
• LSIL

Interventions

Type	Name	Description
BIOLOGICAL	pNGVL4aCRTE6E7L2	Naked pNGVL4aCRTE6E7L2 DNA plasmid
BIOLOGICAL	TA-CIN	TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.

Timeline

• Start date: 2023-07-10
• Primary completion: 2027-05-01
• Completion: 2027-09-01
• First posted: 2019-04-12
• Last updated: 2025-06-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study