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)
2 other identifiers
interventional
116
1 country
1
Brief Summary
Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL. Objective: To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL). Eligibility: Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments. Design: Participants will be screened with a chart review or through another protocol. Visit 1 At visit 1, participants may have a pregnancy test, blood test, or physical exam. Pregnant participants cannot be in the study. Eligible participants will get the shingles vaccine as an injection. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 2 Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 3 Visit 3 will be 3 months after visit 2. Participants will have blood taken. Participants may be able to get an additional vaccine the same day as the shingles vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedStudy Start
First participant enrolled
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedResults Posted
Study results publicly available
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2023
CompletedAugust 4, 2023
February 1, 2023
1.8 years
October 10, 2018
November 17, 2021
July 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Varicella Zoster Virus (VZV) Seroprotective Titer
Determine the rate of varicella zoster virus (VZV) seroprotective titer achievement in participants following completion of the SHINGRIX 2-dose vaccine series in Chronic Lymphocytic Leukemia (CLL) patients that are treatment naive or receiving therapy with a Bruton Tyrosine Kinase (BTK) Inhibitor (Ibrutinib or Acalabrutinib). The response criteria for achieving serologic response against VZV following the SHINGRIX vaccine are based on a validated luciferase immunoprecipitation assay detecting VZV antiglycoprotein E antibody. The primary endpoint is serologic response defined as ≥ four-fold rises in VZV anti-gE blood. IgG titer achievement after completing the SHINGRIX (RZV) 2-dose vaccine series.
6 months after the first vaccine administration
Secondary Outcomes (2)
Number of Participants That Experienced Serious Adverse Events Following the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
6 months after the first vaccine administration
Number of Participants That Did Not Complete Study Due to Intolerance of the SHINGRIX Vaccine Among Chronic Lymphocytic Leukemia Patients.
6 months after the first vaccine administration
Study Arms (3)
Chronic Lymphocytic Leukemia Patients That Are Treatment Naive
EXPERIMENTALChronic 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
EXPERIMENTALChronic 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
EXPERIMENTALChronic 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.
Interventions
A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (2)
Pleyer C, Laing KJ, Ali MA, McClurkan CL, Soto S, Ahn IE, Nierman P, Maddux E, Lotter J, Superata J, Tian X, Wiestner A, Cohen JI, Koelle DM, Sun C. BTK inhibitors impair humoral and cellular responses to recombinant zoster vaccine in CLL. Blood Adv. 2022 Mar 22;6(6):1732-1740. doi: 10.1182/bloodadvances.2021006574.
PMID: 35157769DERIVEDPleyer C, Ali MA, Cohen JI, Tian X, Soto S, Ahn IE, Gaglione EM, Nierman P, Marti GE, Hesdorffer C, Lotter J, Superata J, Wiestner A, Sun C. Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines. Blood. 2021 Jan 14;137(2):185-189. doi: 10.1182/blood.2020008758.
PMID: 33259596DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Pleyer, M.D. Principal Investigator, NIH, NHLBI
- Organization
- National Institutes of Health (NIH) / The National Heart, Lung, and Blood Institute (NHLBI)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher MT Pleyer, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2018
First Posted
October 11, 2018
Study Start
December 7, 2018
Primary Completion
September 9, 2020
Study Completion
July 12, 2023
Last Updated
August 4, 2023
Results First Posted
December 15, 2021
Record last verified: 2023-02