CompletedPhase 1

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

United States15 participantsStarted 2019-04-04

Plain-language summary

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.

Age range18 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events

Timeframe: Up to 24 months following the first dose of study vaccine

NCT IDNCT02405221

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2025-12-08

Who can participate

Age range18 Years – 100 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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