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
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
• 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
• Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
‣ White blood cell count \> 3,000
⁃ Absolute lymphocyte number \> 500
⁃ Absolute neutrophil count \> 1,000
⁃ Platelets \> 90,000
⁃ Hemoglobulin \> 9
⁃ Total bilirubin \<3 X the institutional limit of normal
⁃ AST(SGOT)/ALT(SGPT) \<3 X the institutional limit of normal
⁃ Creatinine \< 2.5X the institutional limit of normal
• Women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier) prior to study entry and for 3 months after study completion.
• Ability to understand and the willingness to sign a written informed consent document.
• Subject is able to adhere to the study visit schedule and other protocol requirements.