Evidence map›Paper›PMID 39219510›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients.

Lora D Thomas, Einas Batarseh, Lubna Hamdan, Zaid Haddadin, Daniel Dulek, Spyros Kalams, Laura S Stewart, Anna L Stahl, Herdi Rahman, Justin Z Amarin and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07485855 (Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT07485855 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies

TypeinterventionalSponsorAsan Medical CenterRan2025 to 2028Enrolled60ConditionsHematologic Neoplasms, Influenza, ImmunogenicityArmsHigh-dose trivalent inactivated influenza vaccine (HD-IIV3), MF59-adjuvanted quadrivalent inactivated influenza vaccine (aIIV4), Standard-dose trivalent inactivated influenza vaccine (SD-IIV3)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Vaccination of Adults With Cancer: ASCO Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Guideline
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Lora D ThomasDepartment of Medicine, Virginia Commonwealth University Medical Center, Richmond, Virginia, USA.ORCID 0009-0006-1310-6527
Einas BatarsehDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Lubna HamdanDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Zaid HaddadinDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Daniel DulekDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Spyros KalamsDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Laura S Stewart3Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Anna L StahlDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Herdi RahmanDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Justin Z AmarinDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Haya HayekDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Michael IsonRespiratory Disease Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.
Edgar T OvertonDepartment of Medicine, University Hospital, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Steven A PergamDepartment of Medicine, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Andrew J SpiekerDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Natasha B HalasaDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Adult HCT Flu Study

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant RecipientsU01AI132004 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HALASA, NATASHA BASSAM · 2017 to 2019
$2.7M
NCATS NIH HHS UL1 TR002243NIAID NIH HHS U01 AI132004NIH
6 · The paper itself

Abstract

backgroundAdult hematopoietic cell transplant (HCT) recipients are at high risk for influenza-related morbidity and mortality and have suboptimal influenza vaccine immune responses compared to healthy adults, particularly within 2 years of transplant.

methodsThis phase II, double-blind, multicenter randomized controlled trial compared 2 doses of high-dose trivalent (HD-TIV) to 2 doses of standard-dose quadrivalent (SD-QIV) influenza vaccine administered 1 month apart in adults 3-23 months post-allogeneic HCT. Hemagglutinin antibody inhibition (HAI) titers were measured at baseline, 4 weeks following each vaccine dose, and approximately 7 months post-second vaccination. Injection-site and systemic reactions were assessed for 7 days post-vaccination. The primary immunogenicity comparison was geometric mean HAI titer (GMT) at visit 3 (4 weeks after the second dose); we used linear mixed models to estimate adjusted GMT ratios (aGMRs) comparing HD-TIV/SD-QIV for each antigen.

resultsWe randomized 124 adults; 64 received SD-QIV and 60 received HD-TIV. Following the second vaccination, HD-TIV was associated with higher GMTs compared to SD-QIV for A/H3N2 (aGMR = 2.09; 95% confidence interval [CI]: [1.19, 3.68]) and B/Victoria (aGMR = 1.61; 95% CI: [1.00, 2.58]). The increase was not statistically significant for A/H1N1 (aGMR = 1.16; 95% CI: [0.67, 2.02]). There was a trend to more injection-site reactions for HD-TIV after the second vaccination compared to SD-QIV (50% vs 33%; adjusted odds ratio [aOR] = 4.53; 95% CI: [0.71, 28.9]), whereas systemic reactions were similar between groups with both injections.

conclusionsAdult allogeneic HCT recipients who received 2 doses of HD-TIV produced higher HAI antibody responses for A/H3N2 and B/Victoria compared with 2 doses of SD-QIV, with comparable injection-site or systemic reactions.

Indexed as

Antibodies, ViralHematopoietic Stem Cell TransplantationInfluenza, HumanInfluenza VaccinesAdultAgedDouble-Blind MethodFemaleHemagglutination Inhibition TestsHumansImmunogenicity, VaccineInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusMaleMiddle AgedAntibodies, ViralInfluenza Vaccineshematopoietic cell transplantinfluenza vaccine

Identifiers

PMID39219510
PMCPMC10724468

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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.