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1 Division of Respiratory Cell and Molecular Biology, Southampton General Hospital, Southampton, 2 Pharma, London, 3 GNB Limited, Chislehurst, Kent, 4 Dept of Medical Microbiology, Royal Free and University College Medical School, Windeyer Institute of Medical Sciences, London, UK
CORRESPONDENCE: R. Djukanovic, Division of Respiratory Cell and Molecular Biology, Level D, Centre Block, Southhampton General Hospital, Southampton, S016 6YD, UK. E-mail: rd1@soton.ac.uk. Fax: 44 2380777996
Keywords: allergen challenge, asthma, interleukin-5, Mycobacterium vaccae
Received: May 22, 2002
Accepted September 22, 2002
T-helper (Th)2 cytokines play a central role in asthma. Therefore, a double-blind randomised study was conducted to investigate whether heat-killed Mycobacterium vaccae (SRL172), a potent downregulator of Th2 cytokines, can reduce allergen-induced airway responses in patients with atopic asthma.
A total 24 male asthmatics participated in this study. A bronchial allergen challenge was performed along with early (EAR) and late asthmatic responses (LAR) 2 weeks before and 3 weeks after a single intradermal injection of SRL172 or placebo. Before and after treatment, serum immunoglobulin (Ig)E levels and in vitro production of interleukin (IL)-5 by peripheral blood lymphocytes were studied.
Neither treatment affected the EAR. SRL172 caused a mean 34% reduction of the area under the curve of the forced expiratory volume in one second (FEV1) changes during the LAR, which failed to reach conventional statistical significance when compared with placebo. SRL172 also caused a mean 25% decrease in the maximum fall in FEV1 during LAR, but this was not significantly different from placebo. SRL172 caused a reduction in serum IgE and IL-5 synthesis in vitro 3 weeks post-treatment (p=0.07).
This study shows a trend toward significance for the effects of heat-killed Mycobacterium vaccae (SRL172) on allergen-induced airway responses. Further clinical trials, involving multiple dosing, are needed.
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