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
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.
Arms & interventions
- BiologicalpNGVL4aCRTE6E7L2
Naked pNGVL4aCRTE6E7L2 DNA plasmid
- BiologicalTA-CIN
TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.
Outcome measures
Primary
Safety and feasibility of pNGVL4aCRTE6E7L2 DNA vaccination
To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL
Time frame: 12 months
Dose finding
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
Time frame: 12 months
Safety and feasibility of PVX-6 vaccination
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
Time frame: 12 months
Secondary
HPV16 antibody response
Time frame: 12 months
HPV16 CD8 T cell response
Time frame: 12 months
HPV16 L2E7E6 T cell proliferative response
Time frame: 12 months
Clearance of HPV16
Time frame: 12 months
Cytologic clearance
Time frame: 12 months
Eligibility criteria
Study locations (2)
UAB | The University of Alabama at Birmingham
Birmingham, Alabama, 35249
Johns Hopkins University
Baltimore, Maryland, 21231