Clinical Trials /

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

NCT02405221

Description:

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.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: J1553
  • SECONDARY ID: IRB00054202
  • SECONDARY ID: P50CA098252
  • NCT ID: NCT02405221

Conditions

  • HPV16 Associated Cervical Cancer

Interventions

DrugSynonymsArms
TA-CIN (arm)Tissue Antigen - Cervical Intraepithelial NeoplasiaTA-CIN administration via arm
TA-CIN (thigh)Tissue Antigen - Cervical Intraepithelial NeoplasiaTA-CIN administration via thigh

Purpose

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.

Detailed Description

      This is a randomized, multi-center, open label pilot study. The primary goal of this study is
      to determine the safety of TA-CIN vaccine as adjuvant therapy, and to assess evidence of
      induction of HPV antigen-specific immunologic response when administered at different
      locations (arm or thigh). In this pilot study, a single dose level (100µg) assessment of the
      safety and tolerability of administering TA-CIN vaccine three times to either the arm versus
      the thigh of patients who have previously been treated for HPV16-related cervical cancer in
      the past year and are documented to have no evidence of disease recurrence based on
      standard-of-care imaging and/or clinical assessment upon eligibility.

      A total of 14 patients will be enrolled to assess the safety of TA-CIN vaccine via different
      injection sites as adjuvant therapy. Safety assessments will continue for a period for 1
      month after the last vaccination. Few or no serious adverse events (SAEs) are expected from
      this regimen and routes of administration. The motivation for the design is to confirm that
      the dose and site of injection implemented here has minimal or no systemic toxicity, as well
      as determining the preferred injection site that can elicit more potent immune response.

      The study will consist of the following parts:

        -  Screening evaluation

        -  Dosing period and response assessments

        -  Follow-up visits after last dose

      Screening Evaluation:

      The screening visit will be performed within 60 days of the first study drug administration
      visit. The study team will check the results of these screening tests to see if patient
      qualifies to participate.

      Dosing Period:

      Those who meet the study requirements during the screening period will then begin the dosing
      phase of this study. TA-CIN will be given as a single intramuscular injection every 4 weeks
      for a maximum of 3 times. The location of the injection (arm or thigh) will depend on
      randomization. Patients will be assessed for safety and response to treatment during this
      period.

      Follow-Up Period:

      Four follow-up evaluations will be performed during a clinic visit after the last dose of the
      vaccine. These will take place at the following time points: (1) 1-3 weeks after the last
      dose of the study drug, (2) about 6 months after the last dose of the study drug, (3) about
      12 months after the last dose of the study drug, and (4) about 24 months after the last dose
      of the study drug.
    

Trial Arms

NameTypeDescriptionInterventions
TA-CIN administration via thighExperimentalEach 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.
  • TA-CIN (thigh)
TA-CIN administration via armExperimentalEach 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.
  • TA-CIN (arm)

Eligibility Criteria

        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
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and feasibility as assessed by Number of Participants with treatment-related Adverse Events
Time Frame:4 years
Safety Issue:
Description:Safety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0.

Secondary Outcome Measures

Measure:Antibody Response as measured by level of circulating antibody in peripheral blood
Time Frame:up to 4 years
Safety Issue:
Description:Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA).
Measure:T-Cell Response as measured by level of circulating T-cells in peripheral blood
Time Frame:up to 4 years
Safety Issue:
Description:Level of circulating HPV16 E6- and E7- specific CD8+ T cells and/or CD4+ T cells in the peripheral blood pre- and post-vaccination (visualized by ELISPOT)
Measure:Mononucleocyte Response
Time Frame:up to 4 years
Safety Issue:
Description:Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • HPV
  • HPV16
  • Cervical Cancer
  • TA-CIN
  • Vaccine
  • Adjuvant
  • Nickles FaderPI

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