Evidence map›Paper›PMID 25180279›Full record

Trial reportPediatrics2014

Immunologic effects of hydroxyurea in sickle cell anemia.

Howard M Lederman, Margaret A Connolly, Ram Kalpatthi, Russell E Ware, Winfred C Wang, Lori Luchtman-Jones, Myron Waclawiw, Jonathan C Goldsmith, Andrea Swift, James F Casella and 1 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03111589 (Monocytic Expression of Heme Oxidase-1), which is not on this map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT03111589 nacompletednot on this mapstarted 2016, after this paper: background citation

Monocytic Expression of Heme Oxidase-1 (HO-1) in Sickle Cell Patients and Correlation With the Humoral Immune Response to Vaccine and With Allo-immunization

TypeinterventionalSponsorFrancis CorazzaRan2016 to 2018Enrolled102ConditionsSickle Cell DiseaseArmsInactivated influenza A (H1N1) virus vaccine, Blood sampling
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Interventions for chronic kidney disease in people with sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Hydroxyurea (hydroxycarbamide) for sickle cell disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Trial
  6. Observational
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  11. Review
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  14. The sex and gender dimensions of COVID-19: A narrative review of the potential underlying factors.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2022
    Review
  15. Article
  16. Article
  17. Review
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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

11 authors at 9 institutions in 1 country.

Howard M LedermanEudowood Division of Allergy and Immunology, Department of Pediatrics, and.
Margaret A ConnollyClinical Trials and Surveys Corp, Owings Mills, Maryland;
Ram KalpatthiPediatric Hematology, Children's Mercy Hospital, Kansas City, Missouri;
Russell E WareCincinnati Children's Hospital Medical Center, Cincinnati, Ohio;
Winfred C WangDepartment of Hematology, St. Jude Children's Research Hospital, Memphis, Tennessee;
Lori Luchtman-JonesDivision of Hematology, Department of Pediatrics, Children's National Medical Center, Washington, District of Columbia; and.
Myron WaclawiwNational Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Jonathan C GoldsmithNational Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Andrea SwiftEudowood Division of Allergy and Immunology, Department of Pediatrics, and.
James F CasellaDivision of Hematology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland; jcasella@jhmi.edu.
BABY HUG Investigators
ENT and Allergy · USBoston Children's Hospital · USChildren's Mercy Hospital · USChildren's National · USClinical Trials and Surveys Corporation · USJohns Hopkins University · USNational Heart Lung and Blood Institute · USNational Institutes of Health · USSt. Jude Children's Research Hospital · US

Funding

PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIAL - MCC-N01HB7160N01HB007160 · HB · CLINICAL TRIALS AND SURVEYS CORPORATION · PI THOMPSON, BRUCE WILLIAM · 2000 to 2006
$638k
PEDIATRIC HYDROXYUREA PHASE III CLINICAL TRIALN01HB007150 · HB · CHILDREN'S RESEARCH INSTITUTE · PI DRISCOLL, CATHERINE M · 2000 to 2000
$79k
NHLBI NIH HHS N01 HB007150NHLBI NIH HHS N01 HB007160NHLBI NIH HHS N01-HB-07150NHLBI NIH HHS N01-HB-07160.
6 · The paper itself

Abstract

BACKGROUND AND

objectiveSusceptibility to encapsulated bacteria is well known in sickle cell disease (SCD). Hydroxyurea use is common in adults and children with SCD, but little is known about hydroxyurea's effects on immune function in SCD. Because hydroxyurea inhibits ribonucleotide reductase, causing cell cycle arrest at the G1-S interface, we postulated that hydroxyurea might delay transition from naive to memory T cells, with inhibition of immunologic maturation and vaccine responses.

methodsT-cell subsets, naive and memory T cells, and antibody responses to pneumococcal and measles, mumps, and rubella vaccines were measured among participants in a multicenter, randomized, double-blind, placebo-controlled trial of hydroxyurea in infants and young children with SCD (BABY HUG).

resultsCompared with placebo, hydroxyurea treatment resulted in significantly lower total lymphocyte, CD4, and memory T-cell counts; however, these numbers were still within the range of historical healthy controls. Antibody responses to pneumococcal vaccination were not affected, but a delay in achieving protective measles antibody levels occurred in the hydroxyurea group. Antibody levels to measles, mumps, and rubella showed no differences between groups at exit, indicating that effective immunization can be achieved despite hydroxyurea use.

conclusionsHydroxyurea does not appear to have significant deleterious effects on the immune function of infants and children with SCD. Additional assessments of lymphocyte parameters of hydroxyurea-treated children may be warranted. No changes in current immunization schedules are recommended; however, for endemic disease or epidemics, adherence to accelerated immunization schedules for the measles, mumps, and rubella vaccine should be reinforced.

Indexed as

Anemia, Sickle CellAntisickling AgentsChild, PreschoolDouble-Blind MethodFemaleHumansHydroxyureaInfantMaleMeasles-Mumps-Rubella VaccineT-Lymphocyte SubsetsTreatment OutcomeAntisickling AgentsHydroxyureaMeasles-Mumps-Rubella Vaccinehydroxyureaimmunologysickle cell diseasevaccines

Identifiers

PMID25180279
PMCPMC4179098
OpenAlexW2093951481

What OpenQuestion holds

Textmetadata
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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.