Vaccine Responses in Patients With B Cell Malignancies
2 other identifiers
interventional
350
1 country
1
Brief Summary
Background: People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers. Objective: To learn how well vaccines work in people who have certain types of blood cancers. Eligibility: Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas. Design: Participants will get one or more vaccines for illnesses, such as vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses. Participants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series. Participants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response. Participants will have pregnancy tests, if needed. Participants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination. Participants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional. Participation will last for up to 5 years after each vaccine series is received.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 lymphoma
Started Sep 2022
Longer than P75 for phase_4 lymphoma
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
December 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 28, 2021
CompletedStudy Start
First participant enrolled
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2036
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2036
August 4, 2026
July 31, 2026
14.2 years
December 24, 2021
August 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
vaccine titer
4 weeks after completing vaccine series
Study Arms (7)
Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
Chronic Lymphocytic Leukemia Not Receiving Active Treatment
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
Chronic Lymphocytic Leukemia Treatment Break for BTKi
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
Chronic Lymphocytic Leukemia Treatment Naive
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
Chronic Lymphocytic Leukemia Treatment with BTKi
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.
Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies
EXPERIMENTALParticipants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.
Interventions
Pneumococcal Polysaccharide Vaccine (PPSV23)
Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
Respiratory Syncytial Virus Vaccine
Recombinant, adjuvanted Zoster Vaccine (RZV)
Pneumococcal Conjugate Vaccine (PCV13)
Recombinant, adjuvanted Hepatitis (HepB-CpG)
Eligibility Criteria
You may qualify if:
- Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM
- Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:
- Patients with CLL AND one of the following:
- i. Arm 1: Must be treatment naive (no prior cancer directed therapy)
- ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment
- iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine
- iv. Arm 4: Must be receiving treatment with a BTKi for \>= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.
- v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor
- Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:
- i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)
- ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)
- If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
- Age \>= 18 years
- Able to comprehend the investigational nature of the protocol and provide informed consent
You may not qualify if:
- Female patients who are currently pregnant
- History of severe allergic reaction to vaccines
- Concomitant inherited immunodeficiency
- 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.
- Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
- Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
- Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
- Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
- History of allogeneic stem cell transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian U Wiestner, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2021
First Posted
December 28, 2021
Study Start
September 14, 2022
Primary Completion (Estimated)
November 15, 2036
Study Completion (Estimated)
November 15, 2036
Last Updated
August 4, 2026
Record last verified: 2026-07-31