Trial reportJournal of clinical immunology2013
A randomized, controlled dose-finding Phase II study of the M72/AS01 candidate tuberculosis vaccine in healthy PPD-positive adults.
Trial report in Journal of clinical immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00621322 (Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines), which is not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.
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.
Dose Range Study Evaluating Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccines (692342) When Administered to Healthy Adults Aged 18 to 45 Years.
Who cites it
44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 96 citations in OpenAlex.
- 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
- 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
- A Randomized, Controlled Safety, and Immunogenicity Trial of the M72/AS01 Candidate Tuberculosis Vaccine in HIV-Positive Indian Adults.Medicine · 2016Trial
- Safety and immunogenicity of candidate vaccine M72/AS01E in adolescents in a TB endemic setting.Vaccine · 2015Trial
- Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial.Human vaccines & immunotherapeutics · 2015Trial
- Mycobacterium tuberculosis bacteriology and immunity necessitate a multi-pronged immune strategy for vaccination.NPJ vaccines · 2026Review
- CD4 T cell phenotype after AS01-adjuvanted immunization is shaped by prior antigen or pathogen exposure.Frontiers in immunology · 2026Article
- Optimizing antigen selection for the development of tuberculosis vaccines.Cell insight · 2024Review
- Tuberculosis Vaccines and T Cell Immune Memory.Vaccines · 2024Review
- Article
- Review
- A five-antigen Esx-5a fusion delivered as a prime-boost regimen protects againstFrontiers in immunology · 2023Article
- Bridging the gaps to overcome major hurdles in the development of next-generation tuberculosis vaccines.Frontiers in immunology · 2023Review
- Maintenance and recall of memory T cell populations against tuberculosis: Implications for vaccine design.Frontiers in immunology · 2023Review
- Therapeutic Potentials of Immunometabolomic Modulations Induced by Tuberculosis Vaccination.Vaccines · 2022Review
- It Takes a Village: The Multifaceted Immune Response toFrontiers in immunology · 2022Review
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 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn this dose-finding Phase II study (NCT00621322), we evaluated the safety and immunogenicity of different formulations of the candidate tuberculosis vaccine containing the M72 antigen (10/20/40 μg doses) and the liposome-based AS01 Adjuvant System. We aimed to select the lowest-dose combination of M72 and AS01 that was clinically well tolerated with immunogenicity comparable to that of the previously tested M72/AS01B (40 μg) candidate vaccine.
methodsHealthy PPD-positive (induration 3-10 mm) adults (18-45 years) in The Philippines were randomized (4:4:4:4:1:1) to receive 2 injections, 1 month apart, of M72/AS01B (40 μg), M72/AS01E (10 μg), M72/AS01E (20 μg), M72/AS02D (10 μg), M72/Saline (40 μg) or AS01B alone, and were followed up for 6 months. AS01E and AS02D contain half the quantities of the immunostimulants present in AS01B. AS02D is an oil-in-water emulsion. Vaccine selection was based on the CD4(+) T-cell responses at 1 month post vaccination.
resultsAll formulations had a clinically acceptable safety profile with no vaccine-related serious adverse events reported. Two vaccinations of each adjuvanted M72 vaccine induced M72-specific CD4(+) T-cell and humoral responses persisting at 6 months post vaccination. No responses were observed with AS01B alone. One month post second vaccination, CD4(+) T-cell responses induced by each of the three M72/AS01 vaccine formulations were of comparable magnitudes, and all were significantly higher than those induced by M72/AS02D (10 μg) and M72/Saline.
conclusionsThe formulation with the lowest antigen and adjuvant dose, M72/AS01E (10 μg), fulfilled our pre-defined selection criteria and has been selected for further clinical development.
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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.