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Clin Vaccine Immunol. 2017 Sep 5;24(9). pii: e00142-17. doi: 10.1128/CVI.00142-17. Print 2017 Sep.

The Cross-Species Mycobacterial Growth Inhibition Assay (MGIA) Project, 2010-2014.

Author information

1
Aeras, Rockville, Maryland, USA.
2
The Jenner Institute, University of Oxford, Oxford, United Kingdom rachel.tanner@ndm.ox.ac.uk.
3
Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland, USA.
4
South African Tuberculosis Vaccine Initiative and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
5
Departments of Medicine, Microbiology, and Immunology, Albert Einstein College of Medicine, Bronx, New York, USA.
6
Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, United Kingdom.
7
Colorado State University, Fort Collins, Colorado, USA.
8
Public Health England, Porton Down, Salisbury, United Kingdom.
9
The Jenner Institute, University of Oxford, Oxford, United Kingdom.
10
Saint Louis University, St. Louis, Missouri, USA.

Abstract

The development of a functional biomarker assay in the tuberculosis (TB) field would be widely recognized as a major advance in efforts to develop and to test novel TB vaccine candidates efficiently. We present preliminary studies using mycobacterial growth inhibition assays (MGIAs) to detect Mycobacterium bovis BCG vaccine responses across species, and we extend this work to determine whether a standardized MGIA can be applied in characterizing new TB vaccines. The comparative MGIA studies reviewed here aimed to evaluate robustness, reproducibility, and ability to reflect in vivo responses. In doing so, they have laid the foundation for the development of a MGIA that can be standardized and potentially qualified. A major challenge ahead lies in better understanding the relationships between in vivo protection, in vitro growth inhibition, and the immune mechanisms involved. The final outcome would be a MGIA that could be used with confidence in TB vaccine trials. We summarize data arising from this project, present a strategy to meet the goals of developing a functional assay for TB vaccine testing, and describe some of the challenges encountered in performing and transferring such assays.

KEYWORDS:

MGIA; correlates of immunity; mycobacterial growth inhibition assay; tuberculosis; vaccines

PMID:
28701467
PMCID:
PMC5585695
DOI:
10.1128/CVI.00142-17
[Indexed for MEDLINE]
Free PMC Article

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