Dermatologic and Ocular DiseasesIntradermal administration of a killed Mycobacterium vaccae suspension (SRL 172) is associated with improvement in atopic dermatitis in children with moderate-to-severe disease☆
Section snippets
Patients and study design
This study was conducted as a single-center, randomized, double-blind, placebo-controlled trial. The children enrolled in the study, aged 5 to 18 years, attended the University Department of Child Health outpatient clinic at Booth Hall Children’s Hospital, a regional referral center for unusually severe or persistent atopic dermatitis. Sixty children with moderate-to-severe atopic dermatitis were initially considered for the study. Eight children and their parents declined to take part, 7 were
Baseline characteristics
The baseline characteristics of the children with atopic dermatitis who took part in the study are shown in Table I.
Characteristic Placebo SRL 172 P value No. 20 21 Age (y) 10 ± 4 9 ± 4 .3 Male patients, n (%) 12 (60) 6 (29) .04 White patients, n (%) 13 (65) 16 (76) .4 Surface area affected (%) 40 ± 30 38 ± 30 .8 Dermatitis score (0-300) 38 (22-86) 55 (19-69) .8 IgE 1000 kU/mL (≤0.1) 6.6 (1.7-19.7) 9.2 (0.6-15.2) .8 Blood eosinophil
Discussion
This randomized, double-blind, placebo-controlled study demonstrated that in the cohort of children studied, there was a significant reduction in the severity of their atopic dermatitis after a single intradermal injection of killed M vaccae suspension (SRL 172) without any major adverse effects. The lack of any placebo effect may relate to the relatively short duration of the trial and the objectivity of the assessment scores, especially the use of surface area affected by dermatitis as the
Acknowledgements
We thank Dr Leena Patel and Dr Carol Ewing for permission to use their patients in this study; Dr Kath. Bennett, CRC Paediatric and Familial Cancer Group, University of Manchester, for statistical advice; SR Pharma Ltd, London for providing SRL 172 and matching placebo; and Mrs Franscine Radavan and the pharmacy staff at Booth Hall Children’s Hospital for randomizing and allocating the treatments to the patients. Measurements of IgE levels were performed by the staff of the Department of
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Mycobacteria and their world
2012, International Journal of MycobacteriologyCitation Excerpt :Patients treated with M. vaccae have reported a reduction in susceptibility to the common cold and an observation made during studies on the prevention of tuberculosis in HIV-positive patients in Africa recorded an interesting reduction in malaria [67], which still has to be followed up. Atopic dermatitis in children responded well to a single injected treatment with M. vaccae, providing it was prepared in borate buffer [91,92], though a small effect was found on chronic severe dermatitis in adults, using the phosphate-buffered preparation [93]. Borate buffer appears to result in a more stable product than does the phosphate buffer, and discussions with a glycobiologist disclosed that autoclaving in borate breaks down proteins to short amino acid chains suitable for T cell activation, and better preserves the bacterial sugars.
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2011, Advances in ImmunologyInvestigational and unproven therapies in atopic dermatitis
2010, Immunology and Allergy Clinics of North AmericaCitation Excerpt :Because mycobacterial infections are known to trigger Th1 responses, several studies have evaluated the efficacy of heat-killed Mycobacterium vaccae (HKMV) vaccination in the treatment of AD. In a randomized, double-blind, placebo-controlled trial involving children aged 5 to 18 years with moderate to severe AD, Arkwright and David81 showed that a single-dose injection of HKMV (SRL172) significantly decreased involved areas and dermatitis score at a 3-month follow-up, whereas there was no significant change in the group treated with placebo. In an attempt to replicate these results, 2 larger randomized, double-blind, placebo-controlled studies involving patients with AD of similar age range and disease severity using intradermal injection of HKMV or its derivative were performed.
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Reprint requests: Peter D. Arkwright, MB, DPhil, Academic Unit of Child Health, University of Manchester, Booth Hall Children’s Hospital, Charlestown Rd, Manchester, M9 7AA, United Kingdom.