Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL)
About this trial
This is an interventional basic science trial for Safety and Tolerability focused on measuring Ibrutinib, Acalabrutinib, Shingles, Herpes
Eligibility Criteria
- INCLUSION CRITERIA:
- Diagnosis of CLL/SLL which is made according to the updated criteria of the NCI Working Group
- Cohort 1:Treatment naive CLL/SLL patients
- Cohort 2: Subjects must be receiving treatment ibrutinib for at least 6 months prior to administration of the first vaccine dose
- Cohort 3: Subjects must be receiving acalabrutinib for at least 6 months prior to administration of the first vaccine dose
- No active, symptomatic VZV or herpes zoster infection within 12 months prior to vaccination
- No exposure to the live VZV vaccine (ZOSTAVAX) within 12 months prior to vaccination
- No prior exposure to the SHINGRIX vaccine
- Age greater than or equal to 18 years.
- ECOG performance status of 0-2
- Able to comprehend the investigational nature of the protocol and provide informed consent
EXCLUSION CRITERIA:
- Female patients who are currently in pregnancy
- Any uncontrolled active systemic infection
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Severe allergic reaction to any component of SHINGRIX.
- Received intravenous immunoglobulin (IVIG) within 3 months prior to vaccination.
- Concomitant use of immunosuppressive agents (e.g. steroids, radio
therapy, chemotherapy)
- Hereditary or acquired immunodeficiency syndrome unrelated to chronic lymphocytic leukemia
- Non-English speaking individuals will be excluded from the study
Sites / Locations
- National Institutes of Health Clinical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Ibrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.
Chronic Lymphocytic Leukemia Patients Receiving Treatment With Acalabrutinib will be followed for 6 months and receive assessment of serologic response 6- months following the first SHINGRIX vaccine dose.