RecruitingPhase 4NCT05170399

Vaccine Responses in Patients With B Cell Malignancies


Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

500 participants

Start Date

Sep 14, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how well vaccines work in people with B-cell blood cancers (such as CLL, follicular lymphoma, mantle cell lymphoma, or Waldenström macroglobulinemia), who often have weakened immune responses. Researchers want to understand if treatment timing or drug type affects vaccine effectiveness. **You may be eligible if...** - You have been diagnosed with CLL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, NHL, or Waldenström macroglobulinemia - You are 18 years of age or older - You fit into one of the study arms based on your treatment status (untreated, on a BTK inhibitor, on a BCL-2 inhibitor, or off active treatment) **You may NOT be eligible if...** - You have previously been vaccinated against hepatitis B and tested positive for immunity (unless you have documentation of a failed immune response) - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFluzone

Annual Influenza Vaccine

BIOLOGICALShingrix

Recombinant, adjuvanted Zoster Vaccine (RZV)

BIOLOGICALFlucelvax

Annual Influenza Vaccine

BIOLOGICALAfluria

Annual Influenza Vaccine

BIOLOGICALPREVNAR 13

Pneumococcal Conjugate Vaccine (PCV13)

BIOLOGICALHeplisav -B

Recombinant, adjuvanted Hepatitis (HepB-CpG)

BIOLOGICALPfizer-COVID-19 Vaccine

COVID-19 Vaccine

BIOLOGICALFluLaval

Annual Influenza Vaccine

BIOLOGICALFluarix

Annual Influenza Vaccine

BIOLOGICALPNEUMOVAX 23

Pneumococcal Polysaccharide Vaccine (PPSV23)

DRUGPREVNAR 20

Pneumococcal 20-Valent Conjugate Vaccine (PCV20)

DRUGAREXVY, ABRYSVO

Respiratory Syncytial Virus Vaccine


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT05170399


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