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Clinical trialNCT05170399RecruitingPhase 4Interventional

Vaccine Responses in Patients With B Cell Malignancies

SponsorNational Heart, Lung, and Blood Institute (NHLBI)Enrollment350Lymphoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Adrian U Wiestner, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AREXVY, ABRYSVOHeplisav -BStreptococcus pneumoniae type 1 capsular polysaccharide antigen / Streptococcus pneumoniae type 10A capsular polysaccharide antigen / Streptococcus pneumoniae type 11A capsular polysaccharide antigen / Streptococcus pneumoniae type 12F capsular polysaccharide antigen / Streptococcus pneumoniae type 14 capsular polysaccharide antigen / Streptococcus pneumoniae type 15B capsular polysaccharide antigen / Streptococcus pneumoniae type 17F capsular polysaccharide antigen / Streptococcus pneumoniae type 18C capsular polysaccharide antigen / Streptococcus pneumoniae type 19A capsular polysaccharide antigen / Streptococcus pneumoniae type 19F capsular polysaccharide antigen / Streptococcus pneumoniae type 2 capsular polysaccharide antigen / Streptococcus pneumoniae type 20 capsular polysaccharide antigen / Streptococcus pneumoniae type 22F capsular polysaccharide antigen / Streptococcus pneumoniae type 23F capsular polysaccharide antigen / Streptococcus pneumoniae type 3 capsular polysaccharide antigen / Streptococcus pneumoniae type 33F capsular polysaccharide antigen / Streptococcus pneumoniae type 4 capsular polysaccharide antigen / Streptococcus pneumoniae type 5 capsular polysaccharide antigen / Streptococcus pneumoniae type 6B capsular polysaccharide antigen / Streptococcus pneumoniae type 7F capsular polysaccharide antigen / Streptococcus pneumoniae type 8 capsular polysaccharide antigen / Streptococcus pneumoniae type 9N capsular polysaccharide antigen / Streptococcus pneumoniae type 9V capsular polysaccharide antigenStreptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 4 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 5 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6B capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 9V capsular antigen diphtheria CRM197 protein conjugate vaccine →Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 15B capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 33F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 4 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 5 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 6B capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 8 capsular antigen diphtheria CRM197 protein conjugate vaccine / Streptococcus pneumoniae serotype 9V capsular antigen diphtheria CRM197 protein conjugate vaccine →Varicella zoster virus glycoprotein E →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Sept 2022
Primary completion
15 Nov 2036
Completion
15 Nov 2036
Last update posted
4 Aug 2026
Registered enrollment
350
Registry id
NCT05170399

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.