Trial reportVaccine2015
Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting.
Trial report in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00950612 (Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine), which is not on this map. Cited by 81 papers, 5 of them syntheses 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.
Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy HIV-negative Adolescents Living in a TB Endemic Region
Who cites it
81 citing papers in PubMed, 5 syntheses or guidelines pooled it, 138 citations in OpenAlex.
- Delayed-Type Hypersensitivity toInternational journal of molecular sciences · 2026Pooled it
- A systematic review on malaria and Tuberculosis (TB) vaccine challenges in sub-Saharan African clinical trials.PloS one · 2025Pooled it
- Safety and efficacy of tuberculosis vaccine candidates in low- and middle-income countries: a systematic review of randomised controlled clinical trials.BMC infectious diseases · 2023Pooled it
- The Systematic Review and Meta-Analysis on the Immunogenicity and Safety of the Tuberculosis Subunit Vaccines M72/AS01Frontiers in immunology · 2020Pooled it
- Immunogenicity and Safety of the M72/AS01Frontiers in immunology · 2019Pooled it
- Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19.Nature medicine · 2021Trial
- Analysis of cellular and soluble profiles in QuantiFERON nonconverters, converters, and reverters in the Gambia.Immunity, inflammation and disease · 2019Trial
- CD4+ T cell cytokine responses to the DAR-901 booster vaccine in BCG-primed adults: A randomized, placebo-controlled trial.PloS one · 2019Trial
- Trial
- Phase 2b Controlled Trial of M72/AS01The New England journal of medicine · 2018Trial
- 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.Frontiers in immunology · 2018Trial
- Bacillus Calmette-Guérin (BCG) Revaccination of Adults with Latent Mycobacterium tuberculosis Infection Induces Long-Lived BCG-Reactive NK Cell Responses.Journal of immunology (Baltimore, Md. : 1950) · 2016Trial
- A Randomized, Controlled Safety, and Immunogenicity Trial of the M72/AS01 Candidate Tuberculosis Vaccine in HIV-Positive Indian Adults.Medicine · 2016Trial
- Article
- Safety of the M72/AS01 Tuberculosis Vaccine in People Living With HIV: A Systematic Review and Meta-Analysis.Open forum infectious diseases · 2026Article
- mRNA-based tuberculosis vaccines BNT164a1 and BNT164b1 are immunogenic, well tolerated and efficacious in rodent models.Nature immunology · 2026Article
- Screening and in silico evaluation of candidate late-stage antigens for incorporation into multi-stage and post-exposure vaccines against tuberculosis.NPJ vaccines · 2026Review
- CD4 T cell phenotype after AS01-adjuvanted immunization is shaped by prior antigen or pathogen exposure.Frontiers in immunology · 2026Article
- Review
- Adjunctive beneficial effect of c-di-GMP, a STING agonist, in enhancing protective efficacy of TLR4-adjuvanted tuberculosis subunit vaccine formulations.Journal of biomedical science · 2025Article
21 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
18 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundVaccination that prevents tuberculosis (TB) disease, particularly in adolescents, would have the greatest impact on the global TB epidemic. Safety, reactogenicity and immunogenicity of the vaccine candidate M72/AS01E was evaluated in healthy, HIV-negative adolescents in a TB endemic region, regardless of Mycobacterium tuberculosis (M.tb) infection status.
methodsIn a phase II, double-blind randomized, controlled study (NCT00950612), two doses of M72/AS01E or placebo were administered intramuscularly, one month apart. Participants were followed-up post-vaccination, for 6 months. M72-specific immunogenicity was evaluated by intracellular cytokine staining analysis of T cells and NK cells by flow cytometry.
resultsNo serious adverse events were recorded. M72/AS01E induced robust T cell and antibody responses, including antigen-dependent NK cell IFN-γ production. CD4 and CD8 T cell responses were sustained at 6 months post vaccination. Irrespective of M.tb infection status, vaccination induced a high frequency of M72-specific CD4 T cells expressing multiple combinations of Th1 cytokines, and low level IL-17. We observed rapid boosting of immune responses in M.tb-infected participants, suggesting natural infection acts as a prime to vaccination.
conclusionsThe clinically acceptable safety and immunogenicity profile of M72/AS01E in adolescents living in an area with high TB burden support the move to efficacy trials.
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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.