drugset / Trial / NCT05170399

Vaccine Responses in Patients With B Cell Malignancies

NCT05170399

Phase 4 Recruiting 350 enrolled National Heart, Lung, and Blood Institute (NHLBI)
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2022-09-14
Primary completion
2026-08-16
Completion
2026-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Afluria Vaccine
Subject Arexvy Vaccine
Subject BNT162b2 Messenger RNA (mRNA)
Subject Flucelvax Vaccine
Subject HEPLISAV-B Vaccine
Subject Influenza Virus Vaccine Vaccine
Subject PCV20 Vaccine
Subject Pneumovax 23 Vaccine
Subject Prevnar 13 Vaccine
Subject RSVpreF Vaccine
Subject VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E Vaccine

Indications