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. 2014 Nov 12;32(48):6390-5.
doi: 10.1016/j.vaccine.2014.09.065. Epub 2014 Oct 11.

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

Belinda Dagg  1 , Jason Hockley  2 , Peter Rigsby  2 , Mei M Ho  3
Affiliations

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

Belinda Dagg et al. Vaccine. .

Abstract

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.

Keywords: ATP; BCG; Reference reagent; Stability; Vaccine; Viability; WHO.

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Figures

Fig. 1
Fig. 1
The distribution of CFU counts per ampoule of BCG Moreau-RJ sub-strain preparation performed in participating laboratories, excluding one outlier from Laboratory 7.
Fig. 2
Fig. 2
The distribution of ATP content of BCG Moreau-RJ sub-strain preparation performed in participating laboratories, excluding two outliers from Laboratory 11.
Fig. 3
Fig. 3
The multiplex PCR fingerprints of BCG Moreau-RJ sub-strain preparation performed in participating laboratories as numbered.
Fig. 4
Fig. 4
Trend monitoring of real time stability data of WHO Reference Reagents of BCG vaccine of various sub-strains of (a) Danish 1331 formula image, (b) Tokyo 172-1 formula image, (c) Russian BCG-I formula image, and (d) Moreau-RJ formula image, using the cultural viable count assay.
See this image and copyright information in PMC

References

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