NCT02405221CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 27 Mar 2015
- Start date
- 4 Apr 2019
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Cervical cancer
- NCT number
- NCT02405221
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 15
- From 4 Apr 2019 to the primary completion date, 31 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs
- A history of current or recent concurrent malignancy (≤5 years) except basal cell cancer.
Other illness
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- Active or chronic HIV, HBV, or HCV infection
- Patients who have an active autoimmune disease
Other
- Pregnant or lactating
- Women of childbearing potential
- Patients with non-healed wounds
- Inability to understand or unwillingness to sign an informed consent document
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Women & Infants Center, University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.