Evidence map›Paper›PMID 29632533›Full record

Trial reportFrontiers in immunology2018

Adjuvant-Associated Peripheral Blood mRNA Profiles and Kinetics Induced by the Adjuvanted Recombinant Protein Candidate Tuberculosis Vaccine M72/AS01 in Bacillus Calmette-Guérin-Vaccinated Adults.

Robert A van den Berg, Laurane De Mot, Geert Leroux-Roels, Viviane Bechtold, Frédéric Clement, Margherita Coccia, Erik Jongert, Thomas G Evans, Paul Gillard, Robbert G van der Most

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Frontiers in immunology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01669096 (Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 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.

NCT01669096 phase2completednot on this map

Evaluation of the Kinetics of mRNA Expression After Two Doses of GSK Biologicals' Candidate Tuberculosis (Tuberculosis) Vaccine GSK 692342 in Healthy Adults

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2013Enrolled20ConditionsTuberculosisArmsGSK Biologicals' investigational TB vaccine GSK 692342
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Immunogenicity and Safety of the M72/AS01Frontiers in immunology · 2019
    Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
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  15. Review
  16. Review
  17. Article
  18. Article
  19. Advancing Adjuvants forFrontiers in immunology · 2021
    Review
  20. Review
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

10 authors.

Robert A van den BergGSK, Wavre, Belgium.
Laurane De MotGSK, Wavre, Belgium.
Geert Leroux-RoelsCentre for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium.
Viviane BechtoldGSK, Wavre, Belgium.
Frédéric ClementCentre for Vaccinology (CEVAC), Ghent University Hospital, Ghent, Belgium.
Margherita CocciaGSK, Wavre, Belgium.
Erik JongertGSK, Wavre, Belgium.
Thomas G EvansAERAS, Rockville, MD, United States.
Paul GillardGSK, Wavre, Belgium.
Robbert G van der MostGSK, Wavre, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Systems biology has the potential to identify gene signatures associated with vaccine immunogenicity and protective efficacy. The main objective of this study was to identify optimal postvaccination time points for evaluating peripheral blood RNA expression profiles in relation to vaccine immunogenicity and potential efficacy in recipients of the candidate tuberculosis vaccine M72/AS01. In this phase II open-label study (NCT01669096; https://clinicaltrials.gov/), healthy Bacillus Calmette-Guérin-primed, HIV-negative adults were administered two doses (30 days apart) of M72/AS01. Twenty subjects completed the study and 18 subjects received two doses. Blood samples were collected pre-dose 1, pre-dose 2, and 1, 7, 10, 14, 17, and 30 days post-dose 2. RNA expression in whole blood (WB) and peripheral blood mononuclear cells (PBMCs) was quantified using microarray technology. Serum interferon-gamma responses and M72-specific CD4

Indexed as

Adjuvants, ImmunologicAdolescentAdultBCG VaccineCD4-Positive T-LymphocytesDrug CombinationsFemaleGene Expression ProfilingHumansInterferon-gammaKineticsLeukocytes, MononuclearLipid AMaleMiddle AgedMycobacterium tuberculosisAdjuvants, Immunologicadjuvant system 01BCG VaccineDrug CombinationsInterferon-gammaLipid ARecombinant ProteinsRNA, MessengerSaponinsadjuvant systeminnate immunityinterferontranscriptometuberculosisvaccine

Identifiers

PMID29632533
PMCPMC5879450

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.