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Vaccine Responses in Patients With B Cell Malignancies
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
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 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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2022-09-14
Completion Date
2026-08-16
Last Updated
2026-02-05
Healthy Volunteers
No
Conditions
Interventions
Fluzone
Annual Influenza Vaccine
Shingrix
Recombinant, adjuvanted Zoster Vaccine (RZV)
Flucelvax
Annual Influenza Vaccine
Afluria
Annual Influenza Vaccine
PREVNAR 13
Pneumococcal Conjugate Vaccine (PCV13)
Heplisav -B
Recombinant, adjuvanted Hepatitis (HepB-CpG)
Pfizer-COVID-19 Vaccine
COVID-19 Vaccine
FluLaval
Annual Influenza Vaccine
Fluarix
Annual Influenza Vaccine
PNEUMOVAX 23
Pneumococcal Polysaccharide Vaccine (PPSV23)
PREVNAR 20
Pneumococcal 20-Valent Conjugate Vaccine (PCV20)
AREXVY, ABRYSVO
Respiratory Syncytial Virus Vaccine
Locations (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, United States