Evidence map›Paper›PMID 37800415›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

The Durability of Antibody Responses of Two Doses of High-Dose Relative to Two Doses of Standard-Dose Inactivated Influenza Vaccine in Pediatric Hematopoietic Cell Transplant Recipients: A Multi-Center Randomized Controlled Trial.

Jennifer E Schuster, Lubna Hamdan, Daniel E Dulek, Carrie L Kitko, Einas Batarseh, Zaid Haddadin, Laura S Stewart, Anna Stahl, Molly Potter, Herdi Rahman and 18 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02860039 (Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT02860039 phase2completednot on this map

Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant Recipients

TypeinterventionalSponsorVanderbilt-Ingram Cancer CenterRan2016 to 2024Enrolled170ConditionsHematopoietic Cell Transplantation Recipient, Malignant Neoplasm, InfluenzaArmsTrivalent Influenza Vaccine, Quadrivalent Influenza Vaccine, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. 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

28 authors at 10 institutions in 1 country.

Jennifer E SchusterDepartment of Pediatrics, Children's Mercy Kansas City, Kansas City, Missouri, USA.
Lubna HamdanDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Daniel E DulekDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Carrie L KitkoDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Einas BatarsehDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Zaid HaddadinDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Laura S StewartDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Anna StahlDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Molly PotterDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Herdi RahmanDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Spyros A KalamsDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Claire E BocchiniDepartment of Pediatrics, Division of Infectious Diseases, Baylor College of Medicine, and Texas Children's Hospital, Houston, Texas, USA.
Elizabeth A MoultonDepartment of Pediatrics, Division of Infectious Diseases, Baylor College of Medicine, and Texas Children's Hospital, Houston, Texas, USA.
Susan E CoffinDepartment of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Monica I ArduraDepartment of Pediatrics, Division of Infectious Diseases & Host Defense, Nationwide Children's Hospital and The Ohio State University, Columbus, Ohio, USA.
Rachel L WattierDepartment of Pediatrics, University of California San Francisco and Benioff Children's Hospital - San Francisco, San Francisco, California, USA.
Gabriela MaronDepartment of Infectious Diseases, Children's, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Michael GrimleyDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Grant PaulsenDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Christopher J HarrisonDepartment of Infectious Diseases, University of Missouri at Kansas City, Kansas City, Missouri, USA.
Jason L FreedmanDepartment of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Paul A CarpenterDepartment of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, Washington, USA.
Janet A EnglundDepartment of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, Washington, USA.
Flor M MunozDepartment of Pediatrics, Division of Infectious Diseases, Baylor College of Medicine, and Texas Children's Hospital, Houston, Texas, USA.
Lara Danziger-IsakovDepartment of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 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.
Pediatric HCT Flu Study
Vanderbilt University Medical Center · USCincinnati Children's Hospital Medical Center · USBaylor College of Medicine · USUniversity of Missouri–Kansas City · USSeattle Children's Hospital · USUniversity of Pennsylvania · USChildren's Mercy Hospital · USNationwide Children's Hospital · USSt. Jude Children's Research Hospital · USUniversity of California, San Francisco · US

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
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Tennessee CFAR: Implementation of Culturally Responsive Trauma-Informed Care with Youth with HIV in Memphis, TNP30AI110527 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI John Koethe · 2015 to 2026
$27.5M
Comparison of High vs. Standard Dose Flu Vaccine in Pediatric Stem Cell Transplant RecipientsU01AI125135 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HALASA, NATASHA BASSAM · 2016 to 2018
$4.9M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR002243NIAID NIH HHS P30 AI110527NIAID NIH HHS U01 AI125135
6 · The paper itself

Abstract

backgroundOur previous study established a 2-dose regimen of high-dose trivalent influenza vaccine (HD-TIV) to be immunogenically superior compared to a 2-dose regimen of standard-dose quadrivalent influenza vaccine (SD-QIV) in pediatric allogeneic hematopoietic cell transplant (HCT) recipients. However, the durability of immunogenicity and the role of time post-HCT at immunization as an effect modifier are unknown.

methodsThis phase II, multi-center, double-blinded, randomized controlled trial compared HD-TIV to SD-QIV in children 3-17 years old who were 3-35 months post-allogeneic HCT, with each formulation administered twice, 28-42 days apart. Hemagglutination inhibition (HAI) titers were measured at baseline, 28-42 days following each dose, and 138-222 days after the second dose. Using linear mixed effects models, we estimated adjusted geometric mean HAI titer ratios (aGMR: HD-TIV/SD-QIV) to influenza antigens. Early and late periods were defined as 3-5 and 6-35 months post-HCT, respectively.

resultsDuring 3 influenza seasons (2016-2019), 170 participants were randomized to receive HD-TIV (n = 85) or SD-QIV (n = 85). HAI titers maintained significant elevations above baseline for both vaccine formulations, although the relative immunogenic benefit of HD-TIV to SD-QIV waned during the study. A 2-dose series of HD-TIV administered late post-HCT was associated with higher GMTs compared to the early post-HCT period (late group: A/H1N1 aGMR = 2.16, 95% confidence interval [CI] = [1.14-4.08]; A/H3N2 aGMR = 3.20, 95% CI = [1.60-6.39]; B/Victoria aGMR = 1.91, 95% CI = [1.01-3.60]; early group: A/H1N1 aGMR = 1.03, 95% CI = [0.59-1.80]; A/H3N2 aGMR = 1.23, 95% CI = [0.68-2.25]; B/Victoria aGMR = 1.06, 95% CI = [0.56-2.03]).

conclusionsTwo doses of HD-TIV were more immunogenic than SD-QIV, especially when administered ≥6 months post-HCT. Both groups maintained higher titers compared to baseline throughout the season. CLINICAL TRIALS REGISTRATION: NCT02860039.

Indexed as

Hematopoietic Stem Cell TransplantationInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAdolescentAntibodies, ViralAntibody FormationChildChild, PreschoolHemagglutination Inhibition TestsHumansInfluenza A Virus, H3N2 SubtypeTransplant RecipientsVaccines, InactivatedAntibodies, ViralInfluenza VaccinesVaccines, Inactivatedhigh doseinfluenzapediatricsstem cell recipientsvaccination

Identifiers

PMID37800415
PMCPMC10810702
OpenAlexW4387392842

What OpenQuestion holds

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LicenceCC BY
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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.