Report of an International collaborative study to establish the first WHO reference reagents for BCG vaccines of three different sub-strains

Ho, Mei Mei; Markey, Kevin; Rigsby, Peter; Hockley, Jason; Corbel, Michael J.

doi:10.1016/j.vaccine.2010.10.066

Cited by 20 publications

(22 citation statements)

References 9 publications

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“…The heterogeneity of BCG substrains is being clarified. BCG Tokyo 172 is important as a standard substrain of the BCG vaccine used by the WHO (8). It has been noted that BCG Tokyo 172 is composed of two subpopulations with different morphologies (12).…”

Section: Discussionmentioning

confidence: 99%

Lipid Phenotype of Two Distinct Subpopulations of Mycobacterium bovis Bacillus Calmette-Guérin Tokyo 172 Substrain

Naka

Maeda

Niki

et al. 2011

Journal of Biological Chemistry

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Background:The heterogeneity of substrains of Bacillus Calmette-Guérin (BCG), the only available tuberculosis vaccine, was studied. Results: BCG Tokyo 172 types I and II were different in morphology and lipid composition. Conclusion: Type II lacks phenolic glycolipid/phthiocerol dimycocerosate due to a ppsA mutation, and its phenotype was implicated in host responses. Significance: The lipid phenotype is important to evaluate the efficacy of BCG vaccines.

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Section: Discussionmentioning

confidence: 99%

Lipid Phenotype of Two Distinct Subpopulations of Mycobacterium bovis Bacillus Calmette-Guérin Tokyo 172 Substrain

Naka

Maeda

Niki

et al. 2011

Journal of Biological Chemistry

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“…In real-time stability, the lower limits of CFU of these RRs are estimated from the expanded uncertainty (95% confidence) of this and previous collaborative studies on cultural viable count [10] and are 3.37, 29.60, 0.95 or 3.10 million per ampoule for Danish 1331, Tokyo 172-1, Russian BCG-I or Moreau-RJ, respectively. The trend of real time stability collected up to early 2014 is shown in Fig.…”

Section: Resultsmentioning

confidence: 90%

“…Lyophilized BCG samples were reconstituted with 1 ml Dubos medium (SSI Diagnostica, Denmark) or other suitable culture medium; and the BCG suspensions were incubated at 37 °C for 22–26 h. Three 1:2 serial dilutions were prepared from each overnight BCG culture in pre-warmed medium (undiluted, 1:2 and 1:4). The procedures of ATP extraction and estimation were the same as described previously [10]. Results were recorded and data sent to NIBSC for collation and statistical analysis.…”

Section: Methodsmentioning

confidence: 99%

“…The mean CFU per ampoule was calculated from the mean estimates of the colony counts of each dilution [10] following the WHO/TB/Technical Guide/77.9 (in vitro assays of BCG products, unpublished working document in 1977). The choice of formula reflects the appropriate weight given to the number of colonies counted for a test BCG sample at each dilution level.…”

Section: Methodsmentioning

confidence: 99%

“…As in a previous collaborative study [10], three independent methods were used to evaluate the suitability of BCG Moreau-RJ sub-strain as a WHO Reference Reagent. Its content was defined as number of Colony Forming Units (CFU) and amount of ATP (ng) per ampoule.…”

Section: Introductionmentioning

confidence: 99%

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The establishment of sub-strain specific WHO Reference Reagents for BCG vaccine

Dagg

Hockley

Rigsby

et al. 2014

Vaccine

Self Cite

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As the latest addition to the sub-strain specific WHO Reference Reagents of BCG vaccine, an international collaborative study was completed to evaluate the suitability of a candidate BCG Moreau-RJ sub-strain as a WHO Reference Reagent of BCG vaccine. This follows the recent replacement of the WHO 1st International Reference Preparation for BCG vaccine, by three sub-strain specific WHO Reference Reagents of BCG vaccine (Danish 1331, Tokyo 172-1 and Russian BCG-I) in order to complete the coverage of most predominant sub-strains used for BCG vaccine production and distribution for use worldwide. The study used cultural viable count and modified ATP assays to quantify the preparation and multiplex PCR to confirm the identity of the sub-strain. The establishment of this WHO Reference Reagent of BCG vaccine of Moreau-RJ sub-strain was approved by the WHO Expert Committee on Biological Standardization meeting in October 2012. This preparation is available for distribution by NIBSC-MHRA, UK. The data from real-time stability monitoring demonstrated that these Reference Reagents of BCG vaccine are very stable in storage condition at −20 °C. They serve as the valuable source of BCG Reference Reagents for use as comparators (1) for viability assays (such as cultural viable count and modified ATP assays); (2) for in vivo assays (such as the absence of virulent mycobacteria, dermal reactivity and protection assays) in the evaluation of candidate TB vaccines in non-clinical models; (3) for identity assays using molecular biology techniques.

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Contributions of Japanese Scholars to Advances in Clinical TB Management: In TB World, What Kind of Achievements Are Accomplished by Japanese Researchers?

Hase

Saito

2022

Respiratory Disease Series: Diagnostic Tools and Disease Managements

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Report of an International collaborative study to establish the first WHO reference reagents for BCG vaccines of three different sub-strains

Cited by 20 publications

References 9 publications

Lipid Phenotype of Two Distinct Subpopulations of Mycobacterium bovis Bacillus Calmette-Guérin Tokyo 172 Substrain

Lipid Phenotype of Two Distinct Subpopulations of Mycobacterium bovis Bacillus Calmette-Guérin Tokyo 172 Substrain

The establishment of sub-strain specific WHO Reference Reagents for BCG vaccine

Contributions of Japanese Scholars to Advances in Clinical TB Management: In TB World, What Kind of Achievements Are Accomplished by Japanese Researchers?

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