Clinical trial · Interventional
Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
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
NCT02405221CI-TRIAL-00101951completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV16 Associated Cervical Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TA-CIN (arm) | Biological | — | UNRESOLVED |
| TA-CIN (thigh) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TA-CIN administration via thigh
- description
- Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
- interventionNames
- Biological: TA-CIN (thigh)
- type
- EXPERIMENTAL
- label
- TA-CIN administration via arm
- description
- Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
- interventionNames
- Biological: TA-CIN (arm)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.