HPV16 Associated Cervical Cancer Clinical Trial
Official title:
A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients With History of HPV16 Associated Cervical Cancer
Verified date | July 2023 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer.
Status | Active, not recruiting |
Enrollment | 14 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months 2. Patients with no evidence of disease recurrence within 8 weeks of enrollment 3. Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization 4. Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 6. Adequate organ function as defined by study-specified laboratory tests 7. Ability to understand and willingness to sign a written informed consent document 8. Willing and able to comply with study schedule and other protocol requirements Exclusion Criteria: 1. Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions 2. Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive agents such as systemic steroids 3. Prior HPV vaccination 4. Had surgery, chemotherapy, or radiation therapy within 28 days prior to receiving study drug 5. Another investigational product within 28 days prior to receiving study drug 6. Active or chronic HIV, HBV, or HCV infection 7. Pregnant or lactating 8. Patients who have an active autoimmune disease 9. Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs 10. Women of childbearing potential 11. Patients with non-healed wounds 12. A history of current or recent concurrent malignancy (=5 years) except basal cell cancer. 13. Inability to understand or unwillingness to sign an informed consent document |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
United States | Women & Infants Center, University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI), PapiVax Biotech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circulating HPV16 E6-/E7-specific CD8+ T cells | Levels of circulating HPV16 E6- and E7-specific CD8+ T cells in the peripheral blood pre- and post-vaccination (measured using T-cell receptor sequencing) | up to 4 years | |
Other | Levels of HPV-specific neutralizing antibodies | Levels of HPV-specific neutralizing antibodies in the peripheral blood pre- and post-vaccination | up to 4 years | |
Other | Residual HPV16 Viral Load | Residual HPV16 viral load in plasma | 4 years | |
Other | Clinical Response as measured by Time to Disease Recurrence | Clinical response associated with vaccine induced immune responses as measured by Time from administration of TA-CIN to disease recurrence. | 4 years | |
Primary | Safety and feasibility as assessed by Number of Participants with treatment-related Adverse Events | Safety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0. | 4 years | |
Secondary | Antibody Response as measured by level of circulating antibody in peripheral blood | Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA). | up to 4 years | |
Secondary | T-Cell Response as measured by level of circulating T-cells in peripheral blood | Level of circulating HPV16 E6- and E7- specific CD8+ T cells and/or CD4+ T cells in the peripheral blood pre- and post-vaccination (visualized by ELISPOT) | up to 4 years | |
Secondary | Mononucleocyte Response | Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2 | up to 4 years |