ArticleNPJ vaccines2018
The TLR-4 agonist adjuvant, GLA-SE, improves magnitude and quality of immune responses elicited by the ID93 tuberculosis vaccine: first-in-human trial.
Article in NPJ vaccines, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01599897 (A Phase 1, Randomized, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine at Two Dose Levels of the ID93 Antigen and the GLA-SE Adjuvant in Healthy Adults), which is not on this map. Cited by 115 papers.
What it found
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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.
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.
A Phase 1, Randomized, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine at Two Dose Levels of the ID93 Antigen and the GLA-SE Adjuvant in Healthy Adults
Who cites it
115 citing papers in PubMed, 159 citations in OpenAlex.
- Randomized, observer-blind, controlled Phase 1 study of the safety and immunogenicity of the Na-GST-1/Alhydrogel hookworm vaccine with or without a CpG ODN adjuvant in hookworm-naïve adults.PLoS neglected tropical diseases · 2024Trial
- Co-regulation of innate and adaptive immune responses induced by ID93+GLA-SE vaccination in humans.Frontiers in immunology · 2024Trial
- Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults.Nature communications · 2023Trial
- Rv2656c: A Potential Candidate Antigen Associated with Latent Tuberculosis Infection.Vaccines · 2026Article
- Immunological mechanistic action of intravenous BCG-mediated protection against tuberculosis.Cellular and molecular life sciences : CMLS · 2026Review
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- Article
- Screening and in silico evaluation of candidate late-stage antigens for incorporation into multi-stage and post-exposure vaccines against tuberculosis.NPJ vaccines · 2026Review
- Immunotherapy for tuberculosis: current landscape, mechanistic insights, and translational perspectives.Frontiers in immunology · 2026Review
- Taking its TOLL: the role of toll-like receptor 4 in human health and disease, and its potential as a therapeutic target.Frontiers in immunology · 2026Review
- VaxjoGNN: A Graph Neural Network for Ontology-Grounded Vaccine Adjuvant Recommendation.bioRxiv : the preprint server for biology · 2025Article
- RNA vaccines: The dawn of a new age for tuberculosis?Human vaccines & immunotherapeutics · 2025Review
- Peptide-Based Strategies AgainstPharmaceuticals (Basel, Switzerland) · 2025Review
- NIR-II aggregation-induced emission nanoparticles camouflaged with preactivated macrophage membranes for phototheranostics of pulmonary tuberculosis.Nature protocols · 2025Review
- Exploring the Role of Pattern Recognition Receptors as Immunostimulatory Molecules.Immunity, inflammation and disease · 2025Review
- Characterizing TLR4 agonist EmT4™ as an anti-Mycobacterium tuberculosis vaccine adjuvant.ImmunoHorizons · 2025Article
- Tuberculosis vaccines and therapeutic drug: challenges and future directions.Molecular biomedicine · 2025Review
- Evaluating the immunogenicity and safety of ID93 + GLA-SE in BCG-vaccinated healthy adults: a systematic review and meta-analysis of randomized controlled trials.Therapeutic advances in vaccines and immunotherapy · 2025Review
- The PE/PPE family proteins ofFrontiers in immunology · 2025Review
- BCG and beyond: unlocking new frontiers in TB vaccine development.Frontiers in immunology · 2025Review
55 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 3 institutions in 1 country.
Funding
Abstract
Tuberculosis (TB) is the leading cause of infectious death worldwide. Development of improved TB vaccines that boost or replace BCG is a major global health goal. ID93 + GLA-SE is a fusion protein TB vaccine candidate combined with the Toll-like Receptor 4 agonist adjuvant, GLA-SE. We conducted a phase 1, randomized, double-blind, dose-escalation clinical trial to evaluate two dose levels of the ID93 antigen, administered intramuscularly alone or in combination with two dose levels of the GLA-SE adjuvant, in 60 BCG-naive, QuantiFERON-negative, healthy adults in the US (ClinicalTrials.gov identifier: NCT01599897). When administered as 3 injections, 28 days apart, all dose levels of ID93 alone and ID93 + GLA-SE demonstrated an acceptable safety profile. All regimens elicited vaccine-specific humoral and cellular responses. Compared with ID93 alone, vaccination with ID93 + GLA-SE elicited higher titers of ID93-specific antibodies, a preferential increase in IgG1 and IgG3 subclasses, and a multifaceted Fc-mediated effector function response. The addition of GLA-SE also enhanced the magnitude and polyfunctional cytokine profile of CD4
Identifiers
What OpenQuestion holds
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.