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document
Safety and immunogenicity of a cluster specific immunotherapy in children with bronchial asthma and mite allergy . BACKGROUND Cluster specific immunotherapy ( SIT ) is a modern form of allergen immunotherapy allowing safe administration of high allergen doses in a short time interval compared to classic SIT . In the current study , we investigated the safety profile and immunological effect of cluster SIT in children with allergic asthma due to house dust mite allergy . METHODS A total of 34 children ( 6-18 years ) with allergic asthma were assigned to cluster ( n = 22 ) or classic SIT ( n = 12 ) . To achieve a maintenance dose of allergen extract , cluster patients received 14 injections of house dust mite allergen within 6 weeks , whereas the classic SIT group received 14 injections within 14 weeks . Safety was monitored by recording adverse events . Immunogenicity was measured by specific IgG ( Mite ) and IgG4 ( Mite ) , by antibody-blocking properties on basophil activation , and by the T cell subset transcription factors Foxp3 , T-bet , and GATA-3 . RESULTS There were no significant differences in local and systemic side effects between the two groups . In the cluster group , serum levels of specific IgG ( Mite ) ( p < 0.001 ) and specific IgG4 ( Mite ) ( p < 0.001 ) significantly increased after 8 weeks , while it took 12 weeks in the classic SIT group . These data were confirmed by blocking CD63 expression as well as release of cysteinyl leukotrienes after in vitro basophil stimulation . No differences in transcription factor expression were found in the two groups . CONCLUSION Cluster SIT is safe in children . Additionally , our data demonstrated an even more rapid induction of specific immune tolerance . Cluster SIT is an attractive alternative to conventional up-dosing schedules with fewer consultations for the patients .
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Intervention_Physical
cluster specific immunotherapy
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Intervention_Physical
Cluster specific immunotherapy ( SIT )
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Intervention_Pharmacological
14 injections of house dust mite allergen within 6 weeks
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Intervention_Pharmacological
classic SIT group received 14 injections
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Outcome_Other
Safety
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Outcome_Physical
and immunogenicity
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Outcome_Other
safety profile and immunological effect
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Outcome_Other
Safety
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Outcome_Physical
Immunogenicity
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Outcome_Adverse-effects
local and systemic side effects
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Outcome_Physical
serum levels of specific IgG ( Mite )
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Outcome_Physical
specific IgG4 ( Mite )
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Outcome_Physical
CD63 expression
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Outcome_Physical
transcription factor expression
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Outcome_Physical
induction of specific immune tolerance
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Participant_Condition
classic SIT ( n = 12 ) .