Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL

Exclusion Criteria

• •1. History of cancer (excluding basal cell carcinoma of the skin) including cervical cancer
• •2. Eastern Cooperative Oncology Group (ECOG) performance status \>2 (See Appendix G)
• •3. Administration of any blood product within 3 months of enrollment
• •4. Active infection requiring antimicrobial treatment that would interfere with interpretation of adverse events, cutaneous reactions or efficacy. Treatment of minor concurrent infections should be limited to less than 10 days.
• •5. Administration of any vaccine within 8 weeks of enrollment and within 4 weeks for flu vaccine.
• •6. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
• •7. Any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, anticoagulants except platelet inhibitors (NSAIDs as needed for pain are permitted)
• •8. Active drug or alcohol use or dependence that, in the opinion of the Site Investigator, would interfere with adherence to study protocol
• •9. Skin conditions that require consistent use of topical corticosteroids or other local or systemic therapy that may interfere with interpretation or description of skin-related adverse events linked to vaccination
• •10. The standard criteria for prospective clinical trials of medications developed by Drug-Induced Liver Injury Network (established by The National Institute of Diabetes and Digestive and Kidney Diseases) will be used to assess the laboratory test abnormalities. Normal range for these labs will typically be 5 - 40 IU/L for AST; 7 - 56 IU/L for ALT; 0.2 - 1.2 mg/dL for bilirubin. Subjects will be excluded if values are x 2-x 2.5 the upper limit
• •11. Evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, dermatologic, immune disorder, or other disease that may interfere with assessment of safety or efficacy of vaccine activity as indicated in study objectives
• •12. Any known allergic reaction to vaccine components
• •13. Any other medical condition(s) that, in the judgment of the Site Investigator, might interfere with the study or require treatment that might interfere with the study
• •14. Family member of the investigation study staff
• •15. Pregnant or breast-feeding
• •16. Inability to provide informed consent
• •17. A subject with a history or expectation of noncompliance with medications or treatment protocol
• •18. Receipt of (e.g. Gardasil® or Cervarix®) HPV preventative vaccines within 8 years of study enrollment
• •19. Excessive use of acetaminophen or other potentially hepatotoxic drugs