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RECRUITING
NCT05170399
PHASE4

Vaccine Responses in Patients With B Cell Malignancies

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

View on ClinicalTrials.gov

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

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

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States