Evidence map›Paper›PMID 26367374›Full record

Trial reportPloS one2015

Intracellular Cytokine Staining and Flow Cytometry: Considerations for Application in Clinical Trials of Novel Tuberculosis Vaccines.

Steven G Smith, Kaatje Smits, Simone A Joosten, Krista E van Meijgaarden, Iman Satti, Helen A Fletcher, Nadia Caccamo, Francesco Dieli, Francoise Mascart, Helen McShane and 3 more

Open access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 71 citations in OpenAlex.

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  18. Delivery ofFrontiers in immunology · 2023
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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

13 authors at 6 institutions in 4 countries.

Steven G SmithDepartment of Immunology and Infection, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, United Kingdom.
Kaatje SmitsLaboratory of Vaccinology and Mucosal Immunity, Université Libre de Bruxelles, Brussels, Belgium.
Simone A JoostenDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Krista E van MeijgaardenDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
Iman SattiThe Jenner Institute, Old Road Campus Research Building, Roosevelt Drive, Oxford, United Kingdom.
Helen A FletcherDepartment of Immunology and Infection, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, United Kingdom; The Jenner Institute, Old Road Campus Research Building, Roosevelt Drive, Oxford, United Kingdom.
Nadia CaccamoBiomedical Research Centre, Università di Palermo, Palermo, Italy, Dipartimento di Biopatologia e Biotecnologie Mediche e Forensi, Università di Palermo, Palermo, Italy.
Francesco DieliBiomedical Research Centre, Università di Palermo, Palermo, Italy, Dipartimento di Biopatologia e Biotecnologie Mediche e Forensi, Università di Palermo, Palermo, Italy.
Francoise MascartLaboratory of Vaccinology and Mucosal Immunity, Université Libre de Bruxelles, Brussels, Belgium; Immunobiology Clinic, Hôpital Erasme, Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Helen McShaneThe Jenner Institute, Old Road Campus Research Building, Roosevelt Drive, Oxford, United Kingdom.
Hazel M DockrellDepartment of Immunology and Infection, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, United Kingdom.
Tom H M OttenhoffDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.
TBVI TB Biomarker Working Group
Leiden University Medical Center · NLLondon School of Hygiene & Tropical Medicine · GBJenner Institute · GBUniversity of Palermo · ITErasmus Hospital · BEUniversité Libre de Bruxelles · BE

Funding

Wellcome Trust 095780
6 · The paper itself

Abstract

Intracellular cytokine staining combined with flow cytometry is one of a number of assays designed to assess T-cell immune responses. It has the specific advantage of enabling the simultaneous assessment of multiple phenotypic, differentiation and functional parameters pertaining to responding T-cells, most notably, the expression of multiple effector cytokines. These attributes make the technique particularly suitable for the assessment of T-cell immune responses induced by novel tuberculosis vaccines in clinical trials. However, depending upon the particular nature of a given vaccine and trial setting, there are approaches that may be taken at different stages of the assay that are more suitable than other alternatives. In this paper, the Tuberculosis Vaccine Initiative (TBVI) TB Biomarker Working group reports on efforts to assess the conditions that will determine when particular assay approaches should be employed. We have found that choices relating to the use of fresh whole blood or peripheral blood mononuclear cells (PBMC) and frozen PBMC; use of serum-containing or serum-free medium; length of stimulation period and use of co-stimulatory antibodies can all affect the sensitivity of intracellular cytokine assays. In the case of sample material, frozen PBMC, despite some loss of sensitivity, may be more advantageous for batch analysis. We also recommend that for multi-site studies, common antibody panels, gating strategies and analysis approaches should be employed for better comparability.

Indexed as

AdultBiomarkersCytokinesFemaleFlow CytometryHumansMaleT-LymphocytesTuberculosis VaccinesBiomarkersCytokinesTuberculosis Vaccines

Identifiers

PMID26367374
PMCPMC4569436
OpenAlexW2187945036

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.