Evidence map›Paper›PMID 26675348›Full record

Trial reportBlood2016

Administration of interleukin-7 increases CD4 T cells in idiopathic CD4 lymphocytopenia.

Virginia Sheikh, Brian O Porter, Rebecca DerSimonian, Stephen B Kovacs, William L Thompson, Ainhoa Perez-Diez, Alexandra F Freeman, Gregg Roby, JoAnn Mican, Alice Pau and 14 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00839436 (Interleukin-7), which is not on this map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
2.2field-weighted citation impact, top 12% 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.

NCT00839436 phase1 / phase2terminatednot on this map

Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2014Enrolled21ConditionsIdiopathic CD4+ T-LymphocytopeniaArmsCYT107
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 81 citations in OpenAlex.

  1. Reappraisal of Idiopathic CD4 Lymphocytopenia at 30 Years.The New England journal of medicine · 2023
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Immunosenescence: signaling pathways, diseases and therapeutic targets.Signal transduction and targeted therapy · 2025
    Review
  10. Observational
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
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  19. Article
  20. IL-7 Deficiency Exacerbates Atopic Dermatitis in NC/Nga Mice.International journal of molecular sciences · 2023
    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

24 authors at 4 institutions in 1 country.

Virginia SheikhNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;ORCID http://orcid.org/0000-0003-2006-7440
Brian O PorterNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Rebecca DerSimonianNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Stephen B KovacsLeidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD;
William L ThompsonNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Ainhoa Perez-DiezNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Alexandra F FreemanNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Gregg RobyNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
JoAnn MicanNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Alice PauNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Adam RupertLeidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD;
Joseph AdelsbergerLeidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD;
Jeanette HigginsLeidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD;
Jeffrey S BourgeoisNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Stig M R JensenNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
David R MorcockAIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, MD;
Peter D BurbeloDental Clinical Research Core, National Institute of Dental and Craniofacial Research, NIH, Bethesda, MD;
Leah OsnosNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Irina MaricHematology Section, Department of Laboratory Medicine, Clinical Center, NIH, Bethesda, MD; and.
Ven NatarajanLeidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD;
Therese CroughsCytheris Inc., Subsidiary of Cytheris S.A., Issy les Moulineaux, France.
Michael D YaoNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
Jacob D EstesAIDS and Cancer Virus Program, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, MD;
Irini SeretiNational Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, MD;
National Institutes of Health · USLeidos (United States) · USNational Institute of Dental and Craniofacial Research · USNational Institutes of Health Clinical Center · US

Funding

Immunopathogenic Mechanisms of Human Immunodeficiency Virus (HIV) DiseaseZIAAI001121 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SERETI, IRINI · 2010 to 2025
$27.2M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

Idiopathic CD4 lymphopenia (ICL) is a rare syndrome defined by low CD4 T-cell counts (<300/µL) without evidence of HIV infection or other known cause of immunodeficiency. ICL confers an increased risk of opportunistic infections and has no established treatment. Interleukin-7 (IL-7) is fundamental for thymopoiesis, T-cell homeostasis, and survival of mature T cells, which provides a rationale for its potential use as an immunotherapeutic agent for ICL. We performed an open-label phase 1/2A dose-escalation trial of 3 subcutaneous doses of recombinant human IL-7 (rhIL-7) per week in patients with ICL who were at risk of disease progression. The primary objectives of the study were to assess safety and the immunomodulatory effects of rhIL-7 in ICL patients. Injection site reactions were the most frequently reported adverse events. One patient experienced a hypersensitivity reaction and developed non-neutralizing anti-IL-7 antibodies. Patients with autoimmune diseases that required systemic therapy at screening were excluded from the study; however, 1 participant developed systemic lupus erythematosus while on study and was excluded from further rhIL-7 dosing. Quantitatively, rhIL-7 led to an increase in the number of circulating CD4 and CD8 T cells and tissue-resident CD3 T cells in the gut mucosa and bone marrow. Functionally, these T cells were capable of producing cytokines after mitogenic stimulation. rhIL-7 was well tolerated at biologically active doses and may represent a promising therapeutic intervention in ICL. This trial was registered at www.clinicaltrials.gov as #NCT00839436.

Indexed as

AdultAgedCD4-Positive T-LymphocytesDose-Response Relationship, DrugFemaleHumansImmunologic FactorsImmunophenotypingInterleukin-7MaleMiddle AgedRecombinant ProteinsT-Lymphocytopenia, Idiopathic CD4-PositiveYoung AdultImmunologic FactorsInterleukin-7Recombinant Proteins

Identifiers

PMID26675348
PMCPMC4768432
OpenAlexW2415710472

What OpenQuestion holds

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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.