Evidence map›Paper›PMID 39381003›Full record

Trial reportFrontiers in immunology2024

Co-regulation of innate and adaptive immune responses induced by ID93+GLA-SE vaccination in humans.

Andrew Fiore-Gartland, Himangi Srivastava, Aaron Seese, Tracey Day, Adam Penn-Nicholson, Angelique Kany Kany Luabeya, Nelita Du Plessis, Andre G Loxton, Linda-Gail Bekker, Andreas Diacon and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in immunology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02465216 (A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT02465216 phase2completednot on this map

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion

TypeinterventionalSponsorAccess to Advanced Health Institute (AAHI)Ran2015 to 2017Enrolled60ConditionsPulmonary TuberculosisArmsPlacebo, ID93 + GLA-SE
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

16 authors.

Andrew Fiore-GartlandVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Himangi SrivastavaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Aaron SeeseVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Tracey DayInfectious Diseases and Vaccines, Innovative Medicine, Johnson & Johnson, Leiden, Netherlands.
Adam Penn-NicholsonFoundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.
Angelique Kany Kany LuabeyaSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease & Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Nelita Du PlessisDepartment of Science and Technology/National Research Foundation (DST-NRF) Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Biomedical Research Institute, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Andre G LoxtonDepartment of Science and Technology/National Research Foundation (DST-NRF) Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Biomedical Research Institute, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Linda-Gail BekkerThe Desmond Tutu Human Immunodeficiency Virus (HIV) Centre, University of Cape Town, Cape Town, South Africa.
Andreas DiaconTASK, Cape Town, South Africa.
Gerhard WalzlDepartment of Science and Technology/National Research Foundation (DST-NRF) Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Biomedical Research Institute, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
Zachary K SagawaAccess to Advanced Health Institute, Seattle, WA, United States.
Steven G ReedHDT Bio Corporation, Seattle, WA, United States.
Thomas J ScribaSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease & Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Mark HatherillSouth African Tuberculosis Vaccine Initiative (SATVI), Institute of Infectious Disease & Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Rhea ColerSeattle Children's Research Institute, Center for Global Infectious Disease Research, Seattle Children's, Seattle, WA, United States.

Funding

IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB)75N93021C00029 · NIAID · SEATTLE CHILDREN'S HOSPITAL · PI COLER, RHEA · 2022 to 2025
$35.2M
STRUCTURE/FUNCTION OF THE ACETYLCHOLINE RECEPTORR01NS031744 · NINDS · MAYO CLINIC ROCHESTER · PI SINE, STEVEN M · 1992 to 2023
$7.3M
Seattle Tuberculosis Research Advancement CenterP30AI168034 · NIAID · UNIVERSITY OF WASHINGTON · PI Rhea N Coler, CHETAN SESHADRI · 2022 to 2026
$6.3M
Structure and Function of the Acetylcholine ReceptorR37NS031744 · NINDS · MAYO CLINIC ROCHESTER · PI SINE, STEVEN M · 2001 to 2007
$4.1M
NIAID NIH HHS 75N93021C00029NIAID NIH HHS P30 AI168034NINDS NIH HHS R01 NS031744NINDS NIH HHS R37 NS031744Wellcome Trust
6 · The paper itself

Abstract

Introduction: Development of an effective vaccine against tuberculosis is a critical step towards reducing the global burden of disease. A therapeutic vaccine might also reduce the high rate of TB recurrence and help address the challenges of drug-resistant strains. ID93+GLA-SE is a candidate subunit vaccine that will soon be evaluated in a phase 2b efficacy trial for prevention of recurrent TB among patients undergoing TB treatment. ID93+GLA-SE vaccination was shown to elicit robust CD4+ T cell and IgG antibody responses among recently treated TB patients in the TBVPX-203 Phase 2a study (NCT02465216), but the mechanisms underlying these responses are not well understood. Methods: In this study we used specimens from TBVPX-203 participants to describe the changes in peripheral blood gene expression that occur after ID93+GLA-SE vaccination. Results: Analyses revealed several distinct modules of co-varying genes that were either up- or down-regulated after vaccination, including genes associated with innate immune pathways at 3 days post-vaccination and genes associated with lymphocyte expansion and B cell activation at 7 days post-vaccination. Notably, the regulation of these gene modules was affected by the dose schedule and by participant sex, and early innate gene signatures were correlated with the ID93-specific CD4+ T cell response. Discussion: The results provide insight into the complex interplay of the innate and adaptive arms of the immune system in developing responses to vaccination with ID93+GLA-SE and demonstrate how dosing and schedule can affect vaccine responses.

Indexed as

Adaptive ImmunityImmunity, InnateTuberculosis VaccinesVaccinationAdultAntibodies, BacterialCD4-Positive T-LymphocytesFemaleHumansMaleMycobacterium tuberculosisTuberculosisVaccines, SubunitAntibodies, BacterialTuberculosis VaccinesVaccines, SubunitinnateRNA sequencingsystems immunologytuberculosisvaccines

Identifiers

PMID39381003
PMCPMC11458388

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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.