Report of an International collaborative study to establish the first WHO reference reagents for BCG vaccines of three different sub-strains.
The WHO First International Reference Preparation for BCG vaccine is over forty years old and is no longer available for distribution due to stock depletion and its significant loss of viability. International consultations identified a demand for replacement with sub-strain specific BCG preparations. An International collaborative study was carried out to evaluate three candidates for WHO Reference Reagent for BCG vaccine of Danish 1331, Russian BCG-I and Tokyo 172-1 sub-strains. These candidates were quantified for viability using both cultural viable count and modified ATP assays. The proposal for the establishment of these First WHO Reference Reagents for BCG vaccines was discussed in the WHO Expert Committee on Biological Standardization meeting, October 2009.
Bacteriology Division, NIBSC-HPA, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK. mei.ho@nibsc.hpa.org.uk
Mei M
MM
Ho
Kevin
K
Markey
Peter
P
Rigsby
Jason
J
Hockley
Michael J
MJ
Corbel
D000255:Adenosine Triphosphate / Q000378:metabolism; D015169:Colony Count, Microbial; D006801:Humans; D007391:International Cooperation; D050296:Microbial Viability; D009163:Mycobacterium bovis / Q000276:immunology*; D012015:Reference Standards; D014376:Tuberculosis / Q000517:prevention & control*; D032581:Tuberculosis Vaccines / Q000592:standards*; D014944:World Health Organization
D032581:Tuberculosis Vaccines; D000255:Adenosine Triphosphate