NCT05170399 · National Heart, Lung, and Blood Institute (NHLBI)
Vaccine Responses in Patients With B Cell Malignancies
What this study is about
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.
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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 COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine. Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose. Participants will have pregnancy tests, if needed. Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks. Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional. Participation will last for up to 5 years after each vaccine series is received.
Interventions
BIOLOGICAL
Fluzone
Annual Influenza Vaccine
BIOLOGICAL
Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)
BIOLOGICAL
Flucelvax
Annual Influenza Vaccine
BIOLOGICAL
Afluria
Annual Influenza Vaccine
BIOLOGICAL
PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)
BIOLOGICAL
Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)
BIOLOGICAL
Pfizer-COVID-19 Vaccine
COVID-19 Vaccine
BIOLOGICAL
FluLaval
Annual Influenza Vaccine
BIOLOGICAL
Fluarix
Annual Influenza Vaccine
BIOLOGICAL
PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)
DRUG
PREVNAR 20
Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
DRUG
AREXVY, ABRYSVO
Respiratory Syncytial Virus Vaccine
Primary outcome measures
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
Time frame: 4 weeks after completing vaccine series
vaccine titer
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Or
- 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
Exclusion criteria
- 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
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations