Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer

Completed · Phase 1

Conditions studied: HPV16 Associated Cervical Cancer

In brief

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.

Key facts

Study ID

NCT02405221

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

15

Starts

2019-04-04

Expected to finish

2025-01-31

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months
• Patients with no evidence of disease recurrence within 8 weeks of enrollment
• Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization
• Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
• Adequate organ function as defined by study-specified laboratory tests
• Ability to understand and willingness to sign a written informed consent document
• Willing and able to comply with study schedule and other protocol requirements

You may not qualify if…

• Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
• Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive agents such as systemic steroids
• Prior HPV vaccination
• Had surgery, chemotherapy, or radiation therapy within 28 days prior to receiving study drug
• Another investigational product within 28 days prior to receiving study drug
• Active or chronic HIV, HBV, or HCV infection
• Pregnant or lactating
• Patients who have an active autoimmune disease
• Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs
• Women of childbearing potential
• Patients with non-healed wounds
• A history of current or recent concurrent malignancy (≤5 years) except basal cell cancer.
• Inability to understand or unwillingness to sign an informed consent document

Where it is running

• Women & Infants Center, University of Alabama at Birmingham — Birmingham, Alabama, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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