Overview
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.
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.
Eligibility
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 > 50,000 / 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