About this trial
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
Eligibility criteria
Qualifiers
Patients with persistent (>6 month period) ASC-US/LSIL determined by cervical cytology at study entry (ThinPrep with imaging)
Patients whose cytologic samples are persistent (>6 month period) HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test at study entry. Co-infections with HPV types other than HPV16 are permissible for study entry.
Age ≥ 19 years
Baseline Eastern Cooperative Oncology Group
Disqualifiers
Patients with ASC-US/LSIL determined by cervical cytology at study entry that are HPV16 negative.
Histologic evidence of CIN2+
Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive medications such as steroids.
Prior vaccination with any HPV antigen (prophylactic or therapeutic).
Trial design
Treatments tested in this trial
- pNGVL4aCRTE6E7L2
- TA-CIN
Treatment groups
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Johns Hopkins University
Collaborator