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  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation, Sirturo (bedaquiline) / J&J, Pharmstandard
    Review, Journal:  Tuberculosis: An Update for the Clinician. (Pubmed Central) -  Jan 31, 2025   
    Encouraging clinical results have been seen with the M72/AS01E vaccine...New shorter, all-oral treatment regimens represent a breakthrough, but progress is threatened by rising resistance to bedaquiline...Post-TB lung disease (PTLD) is an under-recognised but growing concern, affecting millions of survivors with lasting respiratory impairment and increased mortality. Continued investment in development of TB vaccines and therapeutics, treatment shortening, and management of TB sequelae is critical to combat this ongoing public health challenge.
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Enrollment open, Trial completion date, Trial primary completion date:  Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults (clinicaltrials.gov) -  Mar 21, 2024   
    P3,  N=20000, Recruiting, 
    The assay includes a range of functional and phenotyping markers to fully characterize TB-specific T-cell responses. Not yet recruiting --> Recruiting | Trial completion date: Aug 2029 --> Apr 2028 | Trial primary completion date: Aug 2029 --> Apr 2028
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Journal:  Updating age-specific contact structures to match evolving demography in a dynamic mathematical model of tuberculosis vaccination. (Pubmed Central) -  May 7, 2022   
    We simulated an M72-AS01E-like tuberculosis vaccine delivered from 2027 and estimated the per cent TB incidence rate reduction (IRR) in 2050 under each update method...We found that model-based TB vaccine impact estimates were relatively insensitive to demography-matched contact matrix updates in an India-like demographic and epidemiologic scenario. Current model-based TB vaccine impact estimates may be reasonably robust to the lack of contact matrix updates, but further research is needed to confirm and generalise this finding.
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Clinical, Journal:  Predicted Structural Variability of Mycobacterium tuberculosis PPE18 Protein With Immunological Implications Among Clinical Strains. (Pubmed Central) -  Jan 26, 2021   
    Recent advancements in vaccinology have led to the development of the M72/AS01E subunit vaccine, of which the major component is the Mycobacterium tuberculosis (MTB) PPE18 protein...Moreover, we found far more residues in the second domain predicted to be B-cell epitopes compared with the first domain. These results suggest an important functional role of the first domain and a role in immune evasion for the second, which extends our knowledge base of the basic biology of the PPE18 protein and indicates the need for further study into non-traditional immunological responses to TB.
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Enrollment closed, Trial completion date, Trial primary completion date:  MESA-TB: Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV (clinicaltrials.gov) -  Dec 19, 2020   
    P2,  N=400, Active, not recruiting, 
    These results suggest an important functional role of the first domain and a role in immune evasion for the second, which extends our knowledge base of the basic biology of the PPE18 protein and indicates the need for further study into non-traditional immunological responses to TB. Not yet recruiting --> Active, not recruiting | Trial completion date: Apr 2022 --> Jul 2022 | Trial primary completion date: Apr 2022 --> Jul 2022
  • ||||||||||  GSK692342 / GSK
    Journal:  Homoplastic single nucleotide polymorphisms contributed to phenotypic diversity in Mycobacterium tuberculosis. (Pubmed Central) -  Dec 16, 2020   
    Among the pe/ppe genes, the homoplastic SNPs were common in a relatively small number of homologous genes, including ppe18, the protein of which is a component of a promising candidate vaccine, M72/AS01E...Our study highlights the potential of homoplastic mutations to produce phenotypic changes. Under selective pressure and during interaction with the host, homoplastic mutations may confer advantages to M. tuberculosis and deserve further characterization.
  • ||||||||||  GSK692342 / GSK
    Review, Journal:  The status of tuberculosis vaccine development. (Pubmed Central) -  Jul 2, 2020   
    Results from clinical efficacy trials, particularly a completed, phase 2b trial for preventing tuberculosis disease in people infected with Mycobacterium tuberculosis using the adjuvanted protein subunit vaccine M72/AS01E give hope. We review the current status of tuberculosis vaccine candidates and outline the diversified vaccine development that are underway.
  • ||||||||||  GSK692342 / GSK
    Journal:  A Trial of M72/AS01E Vaccine to Prevent Tuberculosis. (Pubmed Central) -  Apr 20, 2020   
    We review the current status of tuberculosis vaccine candidates and outline the diversified vaccine development that are underway. No abstract available
  • ||||||||||  Tuberculosis vaccine / Intercell, GSK692342 / GSK
    Journal:  A comparison of antigen-specific T cell responses induced by six novel tuberculosis vaccine candidates. (Pubmed Central) -  Apr 12, 2019   
    Since M72/AS01E induced the highest memory CD4 T cell response it demonstrated the best vaccine take. In the absence of immunological correlates of protection, the likelihood of finding a protective vaccine by empirical testing of candidates may be increased by the addition of candidates that induce distinct immune characteristics.
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Trial completion, Phase classification:  Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults (clinicaltrials.gov) -  Feb 6, 2019   
    P2/3,  N=3595, Completed, 
    In the absence of immunological correlates of protection, the likelihood of finding a protective vaccine by empirical testing of candidates may be increased by the addition of candidates that induce distinct immune characteristics. Active, not recruiting --> Completed | Phase classification: P2 --> P2/3
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Trial termination:  Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Adults With TB Disease (clinicaltrials.gov) -  May 2, 2015   
    P2,  N=142, Terminated, 
    Active, not recruiting --> Completed Completed --> Terminated; Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated.
  • ||||||||||  GSK692342 / GSK, Bill & Melinda Gates Foundation
    Enrollment open, Trial primary completion date:  Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults (clinicaltrials.gov) -  Sep 15, 2014   
    P2,  N=3506, Recruiting, 
    Completed --> Terminated; Due to a safety signal found at a planned interim safety review, further conduct of this safety study is not recommended hence the study was terminated. Not yet recruiting --> Recruiting | Trial primary completion date: Nov 2017 --> Nov 2018