ArticleJournal of immunological methods2019
Optimisation, harmonisation and standardisation of the direct mycobacterial growth inhibition assay using cryopreserved human peripheral blood mononuclear cells.
Article in Journal of immunological methods, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Development and application of the direct mycobacterial growth inhibition assay: a systematic review.Frontiers in immunology · 2024Pooled it
- Whole Blood Mycobacterial Growth Assays for Assessing Human Tuberculosis Susceptibility: A Systematic Review and Meta-Analysis.Frontiers in immunology · 2021Pooled it
- Functional in-vitro evaluation of the non-specific effects of BCG vaccination in a randomised controlled clinical study.Scientific reports · 2022Trial
- Induction of Functional Specific Antibodies, IgG-Secreting Plasmablasts and Memory B Cells Following BCG Vaccination.Frontiers in immunology · 2021Trial
- Future Prospects for Using Clinical Phenotypes in Tuberculosis Precision Medicine-An Approach for Clinical Management.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Review
- Antibodies in tuberculosis: functional capacity as key determinant.Infection and immunity · 2026Review
- Rapid On-Demand Point-of-Care Monitoring of Clozapine and Its Metabolite Norclozapine Using Miniature Mass Spectrometry.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Impact of helminth co-infection and treatment on mycobacterial growth inhibition in UK migrants with TB infection.IJTLD open · 2025Article
- Mycobacterium tuberculosis growth inhibition by peripheral blood mononuclear cells from household contacts is not affected by previous SARS-CoV-2 infection.Gates open research · 2025Article
- Functional and phenotypic characterization of peripheral blood mononuclear cells from tuberculosis patients in Southern Thailand.Frontiers in immunology · 2025Article
- A modified mycobacterial growth inhibition assay for the functional assessment of vaccine-mediated immunity.NPJ vaccines · 2024Article
- BCG vaccination-induced acquired control of mycobacterial growth differs from growth control preexisting to BCG vaccination.Nature communications · 2024Article
- A non-human primate in vitro functional assay for the early evaluation of TB vaccine candidates.NPJ vaccines · 2021Article
- TheF1000Research · 2021Article
- Innate Immune Responses ofFrontiers in cellular and infection microbiology · 2021Article
- Adaption of the ex vivo mycobacterial growth inhibition assay for use with murine lung cells.Scientific reports · 2020Article
- Disparate Tuberculosis Disease Development in Macaque Species Is Associated With Innate Immunity.Frontiers in immunology · 2019Article
- Tools for Assessing the Protective Efficacy of TB Vaccines in Humans:Frontiers in immunology · 2019Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
Abstract
A major challenge to tuberculosis (TB) vaccine development is the lack of a validated immune correlate of protection. Mycobacterial growth inhibition assays (MGIAs) represent an unbiased measure of the ability to control mycobacterial growth in vitro. A successful MGIA could be applied to preclinical and clinical post-vaccination samples to aid in the selection of novel vaccine candidates at an early stage and provide a relevant measure of immunogenicity and protection. However, assay harmonisation is critical to ensure that comparable information can be extracted from different vaccine studies. As part of the FP7 European Research Infrastructures for Poverty Related Diseases (EURIPRED) consortium, we aimed to optimise the direct MGIA, assess repeatability and reproducibility, and harmonise the assay across different laboratories. We observed an improvement in repeatability with increased cell number and increased mycobacterial input. Furthermore, we determined that co-culturing in static 48-well plates compared with rotating 2 ml tubes resulted in a 23% increase in cell viability and a 500-fold increase in interferon-gamma (IFN-γ) production on average, as well as improved reproducibility between replicates, assay runs and sites. Applying the optimised conditions, we report repeatability to be <5% coefficient of variation (CV), intermediate precision to be <20% CV, and inter-site reproducibility to be <30% CV; levels within acceptable limits for a functional cell-based assay. Using relevant clinical samples, we demonstrated comparable results across two shared sample sets at three sites. Based on these findings, we have established a standardised operating procedure (SOP) for the use of the direct PBMC MGIA in TB vaccine development.
Indexed as
Identifiers
What OpenQuestion holds
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.