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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Naked pNGVL4aCRTE6E7L2 DNA plasmid
TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.
UAB | The University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGSafety 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
HPV16 antibody response
To evaluate the levels of circulating antibody specific for HPV-16 in the peripheral blood pre- and post-vaccination
Time frame: 12 months
HPV16 CD8 T cell response
To evaluate the levels of circulating HPV-16 E6- and E7-specific CD8+ T cells and T regulatory cells in the peripheral blood pre- and post-vaccination
Time frame: 12 months
HPV16 L2E7E6 T cell proliferative response
To evaluate the proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
Time frame: 12 months
Clearance of HPV16
To evaluate the presence of high risk HPV, and specifically HPV16 in cytologic specimens pre- and post-vaccination
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Time frame: 12 months
Cytologic clearance
To evaluate changes in the cytopathology of ectocervical and endocervical specimens taken pre- and post-vaccination
Time frame: 12 months