Trial reportNature communications2021
A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients.
Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02503839 (Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the Multidrug-resistant Tuberculosis Pandemic; an Open Label Phase I Clinical Trial of the Therapeutic TB H56), which is not on this map. Cited by 47 papers.
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.
Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the Multidrug-resistant Tuberculosis Pandemic; an Open Label Phase I Clinical Trial of the Therapeutic TB H56:IC31 Vaccine and Cyclooxygenase-inhibitors
Who cites it
47 citing papers in PubMed, 64 citations in OpenAlex.
- Adjunctive ibuprofen in pre-extensively drug-resistant and extensively drug-resistant tuberculosis: a phase IIA open-label pilot clinical trial.Nature communications · 2026Trial
- The Cyclooxygenase 2 Inhibitor Etoricoxib as Adjunctive Therapy in Tuberculosis Impairs Macrophage Control of Mycobacterial Growth.The Journal of infectious diseases · 2024Trial
- Antigen 85B ofVaccines · 2026Review
- Immunotherapy for tuberculosis: emerging modalities, cross-disciplinary innovations, and roadmaps for drug-resistant disease.Frontiers in immunology · 2026Review
- Host-directed therapeutics against antimicrobial-resistant bacterial infections: emerging roles of multi-omics and systems biology.Frontiers in pharmacology · 2026Review
- Novel Multistage SubunitVaccines · 2025Article
- Immunotherapy for tuberculosis: current strategies and future directions.Military Medical Research · 2025Review
- A novel nanoparticle vaccine displaying multistage tuberculosis antigens confers protection in mice infected with H37Rv.NPJ vaccines · 2025Article
- Involvement of nucleic acid-sensing toll-like receptors in human diseases and their controlling mechanisms.Journal of biomedical science · 2025Review
- Immunogenicity and protective efficacy of a multi-antigenic adenovirus-based vaccine candidate againstFrontiers in microbiology · 2025Article
- A multi-epitope vaccine incorporating adhesin-derived antigens protects againstFrontiers in immunology · 2025Article
- Novel Targets for the Development of Tuberculosis Vaccine.Current drug discovery technologies · 2025Review
- Therapeutic vaccination with the Ag85B-Rv2660c-MPT70 fusion protein enhancesFrontiers in immunology · 2025Article
- CD1-restricted T cells: are unconventional allies the key to future TB vaccines?Frontiers in immunology · 2025Review
- Heterologous prime-boost immunization combining parenteral and mucosal routes with different adjuvants mounts long-lived CD4+ T cell responses in lungs.Frontiers in immunology · 2025Article
- A multistage Sendai virus vaccine incorporating latency-associated antigens induces protection against acute and latent tuberculosis.Emerging microbes & infections · 2024Article
- Enhanced Immune Responses AgainstIndian journal of microbiology · 2024Article
- Repurposed Drugs and Plant-Derived Natural Products as Potential Host-Directed Therapeutic Candidates for Tuberculosis.Biomolecules · 2024Review
- Immune correlates of protection as a game changer in tuberculosis vaccine development.NPJ vaccines · 2024Review
- Tuberculosis Vaccines and T Cell Immune Memory.Vaccines · 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
14 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Host-directed-therapy strategies are warranted to fight tuberculosis. Here we assess the safety and immunogenicity of adjunctive vaccination with the H56:IC31 candidate and cyclooxygenase-2-inhibitor treatment (etoricoxib) in pulmonary and extra-pulmonary tuberculosis patients in a randomized open-label phase I/II clinical trial (TBCOX2, NCT02503839). A total of 222 patients were screened, 51 enrolled and randomized; 13 in the etoricoxib-group, 14 in the H56:IC31-group, 12 in the etoricoxib+H56:IC31-group and 12 controls. Three Serious Adverse Events were reported in the etoricoxib-groups; two urticarial rash and one possible disease progression, no Serious Adverse Events were vaccine related. H56:IC31 induces robust expansion of antigen-specific T-cells analyzed by fluorospot and flow cytometry, and higher proportion of seroconversions. Etoricoxib reduced H56:IC31-induced T-cell responses. Here, we show the first clinical data that H56:IC31 vaccination is safe and immunogenic in tuberculosis patients, supporting further studies of H56:IC31 as a host-directed-therapy strategy. Although etoricoxib appears safe, our data do not support therapy with adjunctive cyclooxygenase-2-inhibitors.
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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.