Trial reportNature communications2023
Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults.
Trial report in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03722472 (A Phase 1, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled 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.
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, Double-Blind, Randomized Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Single-Vial Lyophilized ID93 + GLA-SE Vaccine Administered Intramuscularly in Healthy Adult Subjects
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Development and application of the direct mycobacterial growth inhibition assay: a systematic review.Frontiers in immunology · 2024Pooled it
- Microneedles for Vaccination: Mechanistic Foundations, Materials Innovation, Clinical Translation, and Global Health Implementation.Pharmaceutics · 2026Review
- Multifaceted DosR proteins of Mycobacterium tuberculosis: emerging roles for tuberculosis control.Archives of microbiology · 2026Review
- Immunosenescence and Vaccine Efficacy in Aging: Dynamic Interplay of Gut Microbiota and mTOR Signaling Pathways.Aging cell · 2026Review
- Rv2656c: A Potential Candidate Antigen Associated with Latent Tuberculosis Infection.Vaccines · 2026Article
- HowVaccines · 2026Review
- Screening and in silico evaluation of candidate late-stage antigens for incorporation into multi-stage and post-exposure vaccines against tuberculosis.NPJ vaccines · 2026Review
- ID93 + GLA-3M-052-LS vaccine candidate administered by heterologous routes improves BCG efficacy against TB.Frontiers in immunology · 2026Article
- Structure and immunological activity of QS-21 variant fromFrontiers in immunology · 2026Article
- Novel Multistage SubunitVaccines · 2025Article
- The ID93 + GLA-3M-052-LS vaccine candidate elicits mucosal and systemic immunogenicity and protective efficacy againstbioRxiv : the preprint server for biology · 2025Article
- Generalized linear modeling of flow cytometry data to analyze immune responses in tuberculosis vaccine research.NPJ systems biology and applications · 2025Article
- In Silico Targeting and Immunological Profiling of PpiA inPathogens (Basel, Switzerland) · 2025Article
- Progress of anti-tuberculosis drug targets and novel therapeutic strategies.Frontiers in microbiology · 2025Review
- Advances in the structure-based design of protein vaccines for respiratory infectious diseases.Computational and structural biotechnology journal · 2025Review
- A multistage Sendai virus vaccine incorporating latency-associated antigens induces protection against acute and latent tuberculosis.Emerging microbes & infections · 2024Article
- Advancements in Nanoparticle-Based Adjuvants for Enhanced Tuberculosis Vaccination: A Review.Vaccines · 2024Review
- Immune correlates of protection as a game changer in tuberculosis vaccine development.NPJ vaccines · 2024Review
- Optimizing antigen selection for the development of tuberculosis vaccines.Cell insight · 2024Review
- Clinical and Preclinical Methods of Heat-Stabilization of Human Vaccines.Molecular pharmaceutics · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 3 institutions in 2 countries.
Funding
Abstract
Adjuvant-containing subunit vaccines represent a promising approach for protection against tuberculosis (TB), but current candidates require refrigerated storage. Here we present results from a randomized, double-blinded Phase 1 clinical trial (NCT03722472) evaluating the safety, tolerability, and immunogenicity of a thermostable lyophilized single-vial presentation of the ID93 + GLA-SE vaccine candidate compared to the non-thermostable two-vial vaccine presentation in healthy adults. Participants were monitored for primary, secondary, and exploratory endpoints following intramuscular administration of two vaccine doses 56 days apart. Primary endpoints included local and systemic reactogenicity and adverse events. Secondary endpoints included antigen-specific antibody (IgG) and cellular immune responses (cytokine-producing peripheral blood mononuclear cells and T cells). Both vaccine presentations are safe and well tolerated and elicit robust antigen-specific serum antibody and Th1-type cellular immune responses. Compared to the non-thermostable presentation, the thermostable vaccine formulation generates greater serum antibody responses (p < 0.05) and more antibody-secreting cells (p < 0.05). In this work, we show the thermostable ID93 + GLA-SE vaccine candidate is safe and immunogenic in healthy adults.
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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.