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

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ClinicalTrials.gov Identifier: NCT02405221
Recruitment Status : Recruiting
First Posted : April 1, 2015
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
PapiVax Biotech, Inc.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE March 27, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date May 8, 2019
Actual Study Start Date  ICMJE April 4, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
Safety and feasibility as assessed by Number of Participants with treatment-related Adverse Events [ Time Frame: 4 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
Safety as measured by the rate of AEs, serious AEs, deaths and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4) [ Time Frame: 4 years ]
Change History Complete list of historical versions of study NCT02405221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Antibody Response as measured by level of circulating antibody in peripheral blood [ Time Frame: up to 4 years ]
    Level of circulating antibody to HPV16 E6, E7, and L2 in the peripheral blood pre- and post-vaccination (visualized by ELISA).
  • T-Cell Response as measured by level of circulating T-cells in peripheral blood [ Time Frame: up to 4 years ]
    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)
  • Mononucleocyte Response [ Time Frame: up to 4 years ]
    Proliferative responses of peripheral blood mononucleocytes pre- and post-vaccination in response to stimulation by HPV16 E6, E7 and L2
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2019)
  • Circulating HPV16 E6-/E7-specific CD8+ T cells [ Time Frame: up to 4 years ]
    Levels of circulating HPV16 E6- and E7-specific CD8+ T cells in the peripheral blood pre- and post-vaccination (measured using T-cell receptor sequencing)
  • Levels of HPV-specific neutralizing antibodies [ Time Frame: up to 4 years ]
    Levels of HPV-specific neutralizing antibodies in the peripheral blood pre- and post-vaccination
  • Residual HPV16 Viral Load [ Time Frame: 4 years ]
    Residual HPV16 viral load in plasma
  • Clinical Response as measured by Time to Disease Recurrence [ Time Frame: 4 years ]
    Clinical response associated with vaccine induced immune responses as measured by Time from administration of TA-CIN to disease recurrence.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility of TA-CIN Vaccine in HPV16 Associated Cervical Cancer
Official Title  ICMJE 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
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HPV16 Associated Cervical Cancer
Intervention  ICMJE
  • Biological: TA-CIN (arm)
    TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
    Other Name: Tissue Antigen - Cervical Intraepithelial Neoplasia
  • Biological: TA-CIN (thigh)
    TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
    Other Name: Tissue Antigen - Cervical Intraepithelial Neoplasia
Study Arms  ICMJE
  • Experimental: TA-CIN administration via thigh
    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.
    Intervention: Biological: TA-CIN (thigh)
  • Experimental: TA-CIN administration via arm
    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.
    Intervention: Biological: TA-CIN (arm)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2015)
30
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amanda Nickles Fader, MD 410-955-8240 afader1@jhmi.edu
Contact: Richard Roden, PhD 410-955-8804 jhcccro@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02405221
Other Study ID Numbers  ICMJE J1553
IRB00054202 ( Other Identifier: JHMIRB )
P50CA098252 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • PapiVax Biotech, Inc.
Investigators  ICMJE
Principal Investigator: Amanda Nickles Fader, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP