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Vaccine Responses in Patients With B Cell Malignancies

NCT05170399 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-08-04

No results posted yet for this study

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 vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses.

Participants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series.

Participants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response.

Participants will have pregnancy tests, if needed.

Participants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination.

Participants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional.

Participation will last for up to 5 years after each vaccine series is received.

Conditions

Interventions

DRUG

AREXVY, ABRYSVO

Respiratory Syncytial Virus Vaccine

DRUG

PREVNAR 20

Pneumococcal 20-Valent Conjugate Vaccine (PCV20)

BIOLOGICAL

PNEUMOVAX 23

Pneumococcal Polysaccharide Vaccine (PPSV23)

BIOLOGICAL

Heplisav -B

Recombinant, adjuvanted Hepatitis (HepB-CpG)

BIOLOGICAL

PREVNAR 13

Pneumococcal Conjugate Vaccine (PCV13)

BIOLOGICAL

Shingrix

Recombinant, adjuvanted Zoster Vaccine (RZV)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Adrian U Wiestner, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2036-11-15
Completion
2036-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05170399 on ClinicalTrials.gov