Evidence map›Paper›PMID 33259596›Full record

Trial reportBlood2021

Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines.

Christopher Pleyer, Mir A Ali, Jeffrey I Cohen, Xin Tian, Susan Soto, Inhye E Ahn, Erika M Gaglione, Pia Nierman, Gerald E Marti, Charles Hesdorffer and 4 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 82 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 8 pooled it
15.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03685708 phase2completednot on this map

Response to the HEPLISAV-B Hepatitis B Vaccine in Treatment Naive Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's -Tyrosine Kinase Inhibitor (BTK-I)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2018 to 2020Enrolled78ConditionsHepatitis, Safety and TolerabilityArmsHEPLISAV-B
NCT03702231 phase2completednot on this map

Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) Patients That Are Treatment Naive or Receiving Bruton s-Tyrosine Kinase Inhibitor (BTK-I) Therapy

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2018 to 2023Enrolled116ConditionsSafety and Tolerability, Compare SHINGRIX Vaccine Response Rates, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)ArmsZoster Vaccine Recombinant, Adjuvanted
3 · Its place in the literature

Who cites it

82 citing papers in PubMed, 8 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
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  3. Vaccination of Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
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  8. Guideline
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22 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Christopher PleyerHematology Branch, National Heart, Lung, and Blood Institute.
Mir A AliMedical Virology Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, and.
Jeffrey I CohenMedical Virology Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, and.
Xin TianOffice of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.
Susan SotoHematology Branch, National Heart, Lung, and Blood Institute.
Inhye E AhnHematology Branch, National Heart, Lung, and Blood Institute.
Erika M GaglioneHematology Branch, National Heart, Lung, and Blood Institute.
Pia NiermanHematology Branch, National Heart, Lung, and Blood Institute.
Gerald E MartiHematology Branch, National Heart, Lung, and Blood Institute.
Charles HesdorfferHematology Branch, National Heart, Lung, and Blood Institute.
Jennifer LotterHematology Branch, National Heart, Lung, and Blood Institute.
Jeanine SuperataHematology Branch, National Heart, Lung, and Blood Institute.
Adrian WiestnerHematology Branch, National Heart, Lung, and Blood Institute.
Clare SunHematology Branch, National Heart, Lung, and Blood Institute.
National Heart Lung and Blood Institute · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · US

Funding

Immunotherapy of low grade lymphoid malignanciesZIAHL006070 · NHLBI · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · PI WIESTNER, ADRIAN U · 2010 to 2025
$15.9M
Molecular Biology Of Varicella Zoster Virus InfectionZIAAI000430 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI COHEN, JEFFREY · 2009 to 2025
$4.5M
Intramural NIH HHS ZIA HL006070
6 · The paper itself

Abstract

Vaccinations are effective in preventing infections; however, it is unknown if patients with chronic lymphocytic leukemia (CLL) who are treatment naïve (TN) or receiving Bruton tyrosine kinase inhibitors (BTKi's) respond to novel adjuvanted vaccines. Understanding the effect of BTKi's on humoral immunity is timely because BTKi's are widely used and vaccination against coronavirus disease 2019 is urgently needed. In 2 open-label, single-arm clinical trials, we measured the effect of BTKi's on de novo immune response against recombinant hepatitis B vaccine (HepB-CpG) and recall response against recombinant zoster vaccine (RZV) in CLL patients who were TN or on BTKi. The primary end point was serologic response to HepB-CpG (anti-hepatitis B surface antibodies ≥10 mIU/mL) and RZV (≥fourfold increase in anti-glycoprotein E). The response rate to HepB-CpG was lower in patients on BTKi (3.8%; 95% confidence interval [CI], 0.7-18.9) than patients who were TN (28.1%; 95% CI, 15.6-45.4; P = .017). In contrast, the response rate to RZV did not differ significantly between the BTKi (41.5%; 95% CI, 27.8-56.6) and TN cohorts (59.1%; 95% CI, 38.7-76.7; P = .2). BTKi's were associated with a decreased de novo immune response following HepB-CpG, whereas recall immune response following RZV was not significantly affected by BTKi therapy. These trials were registered at www.clinicaltrials.gov as #NCT03685708 (Hep-CpG) and #NCT03702231 (RZV).

Indexed as

ImmunityAdjuvants, ImmunologicAgammaglobulinaemia Tyrosine KinaseAgedFemaleHepatitis B VaccinesHerpes Zoster VaccineHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPatient Outcome AssessmentProtein Kinase InhibitorsVaccinationVaccines, SyntheticAdjuvants, ImmunologicAgammaglobulinaemia Tyrosine KinaseBTK protein, humanHepatitis B VaccinesHerpes Zoster VaccineProtein Kinase InhibitorsVaccines, Synthetic

Identifiers

PMID33259596
PMCPMC7820878
OpenAlexW3110244214

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.