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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

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.

Condition or disease Intervention/treatment Phase
B-Cell Neoplasm Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine Procedure: Biospecimen Collection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rabies Vaccination to Assess Vaccine Responsiveness After B Cell Targeted CAR-T Cell Therapies
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
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.
Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine
Given IM
Other Name: Imovax Rabies

Procedure: Biospecimen Collection
Undergo collection of blood samples

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.
Biological: Wistar Rabies Virus Strain PM-1503-3M Vaccine
Given IM
Other Name: Imovax Rabies

Procedure: Biospecimen Collection
Undergo collection of blood samples




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410900


Contacts
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Contact: Joshua A. Hill 206-667-6504 jahill3@fredhutch.org

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Joshua A. Hill    206-667-6504    jahill3@fredhutch.org   
Principal Investigator: Joshua A. Hill         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Joshua A. Hill Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04410900    
Other Study ID Numbers: RG1007238
NCI-2020-03444 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
10411 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fred Hutchinson Cancer Research Center:
CAR T cells
infection
vaccine
immunity
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases