Could a vaccine stop cervical cancer from coming back?
NCT ID NCT02405221
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested the safety of a vaccine called TA-CIN in 15 people who had been treated for HPV16-related cervical cancer. The goal was to see if the vaccine could help the immune system fight any remaining cancer cells and prevent the cancer from returning. Participants received the vaccine as a shot in the arm or thigh, and researchers monitored for side effects and immune responses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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15 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
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Women & Infants Center, University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States