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Vaccine Responsiveness After CAR-T Cell Therapy

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ClinicalTrials.gov Identifier: NCT04410900
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : April 22, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE August 3, 2020
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Proportion of participants with positive vaccine response [ Time Frame: 4 weeks after the secondary vaccination ]
This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at week 4 post-secondary immunization. This RVNA titer is considered to be evidence of an adequate immune response by the World Health Organization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Proportion of participants with sustained vaccine response [ Time Frame: 6 months after the primary vaccination ]
    This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at 6 months following the primary vaccination in participants who also receive secondary vaccination per-protocol
  • Longitudinal rabies virus neutralizing antibody (RVNA) titers [ Time Frame: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24. ]
    Will compare quantitative levels of RVNA (log10 IU/mL) between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
  • Longitudinal rabies virus binding IgM antibody titers [ Time Frame: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24. ]
    Will compare quantitative levels of anti-rabies virus IgM between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
  • Longitudinal rabies virus binding IgG antibody titers [ Time Frame: From baseline (prior to primary vaccination) through 6 months after primary vaccination based on measurements at weeks 0, 1, 2, 4, 6, 7, 8, 10, and 24. ]
    Will compare quantitative levels of anti-rabies virus IgG between CAR-T cell therapy and healthy participants at weekly intervals after each vaccination and at 6 months after primary vaccination.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Responsiveness After CAR-T Cell Therapy
Official Title  ICMJE Rabies Vaccination to Assess Vaccine Responsiveness After B Cell Targeted CAR-T Cell Therapies
Brief Summary This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. CARTx is a new treatment for patients with B-cell malignancies (cancer of the B-cells), and the long-term effects of CARTx on immune function are not yet well understood. Learning more about vaccine responsiveness in patients who previously underwent CARTx may help doctors better understand immune function. The findings will guide evidence-based strategies for infection prevention to improve outcomes in this rapidly growing population of high-risk individuals.
Detailed Description

OUTLINE:

Patients receive the inactivated rabies vaccine intramuscularly (IM) on day 1 and 6-10 weeks later. Patients also undergo a blood collection prior to each vaccine, and at approximately 1, 2, and 4 weeks after each vaccination. A final blood collection occurs 6 months after the first immunization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE B-Cell Neoplasm
Intervention  ICMJE
  • Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine
    Given IM
    Other Name: Imovax Rabies
  • Procedure: Biospecimen Collection
    Undergo collection of blood samples
Study Arms  ICMJE
  • Experimental: Experimental (anti-rabies vaccine, collection of blood)
    Patients receive anti-rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo collection of blood samples at baseline, and at approximately 1, 2, and 4 weeks after each vaccination. There will be an additional blood draw 6 months (+/- 14 days) after the first immunization.
    Interventions:
    • Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine
    • Procedure: Biospecimen Collection
  • Active Comparator: Control (anti-rabies vaccine, collection of blood)
    Patients receive anti-rabies vaccine IM on day 1 and 6-10 weeks later. Patients also undergo collection of blood samples at baseline, and at approximately 1, 2, and 4 weeks after each vaccination. There will be an additional blood draw 6 months (+/- 14 days) after the first immunization.
    Interventions:
    • Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine
    • Procedure: Biospecimen Collection
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: May 28, 2020)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2025
Estimated Primary Completion Date August 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CARTx RECIPIENTS: Patients must be capable of understanding and providing a written informed consent or, if a minor, have both parents or legal guardian be able to provide informed consent on their behalf
  • CARTx RECIPIENTS: Patients must be 14 years of age or older, of any gender, race or ethnicity
  • CARTx RECIPIENTS: Patients must have had relapse-free survival for >= 6 months after receiving CARTx for B-cell malignancies
  • CARTx RECIPIENTS: Platelet count > 30,000 / mm^3
  • HEALTHY CONTROLS: Patients must be capable of understanding and providing a written informed consent
  • HEALTHY CONTROLS: Patients must be 18 years of age or older, of any gender, race or ethnicity

Exclusion Criteria:

  • CARTx RECIPIENTS: Patients who have received a hematopoietic cell transplant after CARTx
  • CARTx RECIPIENTS: Previously received 1 or more rabies vaccines
  • CARTx RECIPIENTS: Patients who have received lymphodepleting therapies after CARTx and within the past 6 months
  • CARTx RECIPIENTS: Patients with signs or symptoms of active infection
  • CARTx RECIPIENTS: Patients who are pregnant or breastfeeding
  • CARTx RECIPIENTS: Patients with previous known allergies to any component of the vaccine
  • CARTx RECIPIENTS: Patients who have previously experienced a reaction to any vaccine that required medical attention
  • CARTx RECIPIENTS: Study participants who report a severe adverse event following the first rabies vaccine will not be eligible for a second dose
  • CARTx RECIPIENTS: Receiving corticosteroids > 0.5 mg/kg/day prednisone equivalence in the 7 days prior to first or second vaccination
  • HEALTHY CONTROLS: Previously received 1 or more rabies vaccines
  • HEALTHY CONTROLS: Chronic illness
  • HEALTHY CONTROLS: Signs or symptoms of active infection
  • HEALTHY CONTROLS: Pregnant or breastfeeding
  • HEALTHY CONTROLS: Patients with previous known allergies to any component of the vaccine
  • HEALTHY CONTROLS: Previous reaction to a vaccine that required medical attention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joshua A. Hill 206-667-6504 jahill3@fredhutch.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04410900
Other Study ID Numbers  ICMJE RG1007238
NCI-2020-03444 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
10411 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
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
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in a future article will be shared, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: Data will be shared beginning 3 months and ending 5 years following article publication.
Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared to achieve aims in the approved proposal. Proposals should be directed to Joshua A. Hill. To gain access, data requestors will need to sign a data access agreement.
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Joshua A. Hill Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date April 2021

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