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

被引:14
作者
Ho, Mei M. [1 ]
Markey, Kevin [1 ]
Rigsby, Peter
Hockley, Jason
Corbel, Michael J. [1 ]
机构
[1] NIBSC HPA, Bacteriol Div, Potters Bar EN6 3QG, Herts, England
关键词
WHO; Reference Reagent; BCG; MULTIPLEX PCR; SUITABILITY; ASSAY;
D O I
10.1016/j.vaccine.2010.10.066
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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-1 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. (C) 2010 Elsevier Ltd. All rights reserved.
引用
收藏
页码:512 / 518
页数:7
相关论文
共 11 条
[1]   Identification of substrains of BCG vaccine using multiplex PCR [J].
Bedwell, J ;
Kairo, SK ;
Behr, MA ;
Bygraves, JA .
VACCINE, 2001, 19 (15-16) :2146-2151
[2]  
Corbel M J, 2004, Vaccine, V22, P2675, DOI 10.1016/j.vaccine.2004.01.050
[3]  
DAS R E G, 1985, Computer Methods and Programs in Biomedicine, V21, P25
[4]   PROCEDURES FOR DETECTING OUTLYING OBSERVATIONS IN SAMPLES [J].
GRUBBS, FE .
TECHNOMETRICS, 1969, 11 (01) :1-&
[5]   Report of an international collaborative study to establish the suitability of using modified ATP assay for viable count of BCG vaccine [J].
Ho, Mei M. ;
Markey, Kevin ;
Rigsby, Peter ;
Jensen, Sten E. ;
Gairola, Sunil ;
Seki, Masaaki ;
Castello-Branco, Luiz R. ;
Lopez-Vidal, Yolanda ;
Knezevic, Ivana ;
Corbel, Michael J. .
VACCINE, 2008, 26 (36) :4754-4757
[6]   Report on a WHO consultation on the characterisation of BCG vaccines, WHO, Geneva, Switzerland 8-9 Dec 2004 [J].
Ho, MM ;
Corbel, MJ ;
Knezevic, I ;
Roumiantzeff, M .
VACCINE, 2005, 23 (50) :5700-5704
[7]   Development and validation of an ATP method for rapid estimation of viable units in lyophilised BCG Danish 1331 vaccine [J].
Jensen, Sten E. ;
Hubrechts, Peter ;
Klein, Bjarke M. ;
Haslov, Kaare R. .
BIOLOGICALS, 2008, 36 (05) :308-314
[8]   WHO discussion on the improvement of the quality control of BCG vaccines - Pasteur Institute, Paris, France, 7 June 2005 [J].
Knezevic, I ;
Corbel, MJ .
VACCINE, 2006, 24 (18) :3874-3877
[9]  
Markey K, 2010, VACCINE, V28, P6964, DOI [10.1016/j.vaccine.2010.08.045, 10.1016/j.vaccine.2010.07.086]
[10]  
World Health Organization, 1987, WHO TECH REP SER, V745, P60