NCT05170399

Vaccine Responses in Patients With B Cell Malignancies

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Description: This study aims to determine vaccine titers in B-cell malignancies; specifically, in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or other non-Hodgkin lymphomas (NHL) \[follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphomas (MZLs) and indolent NHL not otherwise specified (NOS)\], or in Waldenstrom Macroglobulinemia (WM). Note: Since CLL and SLL are considered the same disease, CLL/SLL will be referred to as CLL hereafter, unless otherwise specified. Objectives: Primary Objective: Determine vaccine titers following vaccination in patients with B-cell malignancies who are either receiving targeted therapies or not receiving active treatment Secondary Objectives: 1. Determine vaccine titers in patients with CLL that are treatment naive, not receiving active treatment, or receiving targeted therapies 2. Determine whether interruption of Bruton tyrosine kinase inhibitor (BTKi) therapy around the time of vaccination improves vaccine titers in patients with CLL 3. Determine vaccine titers in patients with NHL (FL, MCL, MZL, NHL NOS) or WM that are not receiving active treatment, or receiving targeted therapies Endpoints: The primary efficacy endpoint will be the serologic titer against each administered vaccine following completion of the vaccine series in each study arm

Conditions

• Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-14
• Primary completion: 2026-08-16
• Completion: 2026-08-16
• First posted: 2021-12-28
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study