Vaccine Responses in Patients With B Cell Malignancies

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.

Conditions

• Lymphoma

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

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

2026-08-16

Completion

2026-08-16

FDA Drug

Yes

Countries

• United States

Study Locations