BACKGROUND: Prevention of new IgE sensitizations has been described during allergen-specific immunotherapy. However, prospective data using a preventive approach in very young children who would benefit most are missing. We initiated a prospective pilot study investigating the safety, immunomodulatory, and sensitization-preventive effect of sublingual immunotherapy (SLIT) in mono/oligoclonally sensitized, clinically asymptomatic children 2-5 yr of age. METHODS: In this double-blinded, randomized, placebo-controlled pilot study, 31 mono-/oligosensitized children to house-dust mite or grass pollen were included. SLIT with the respective source (n = 15) or placebo (n = 16) was applied. After dose-up-phase therapy was continued for 2 yr. Parents recorded clinical events, vaccinations, and drug intake in a diary. Skin prick testing and specific IgE and IgG measurements were recorded at baseline, 12 and 24 months. At the same time, allergen-specific proliferation and IL10- and TGFβ-dependent Treg function were measured. RESULTS: Preventive application of SLIT in young children was safe (no relevant side effects in 21,170 single applications). After 12 and 24 months of treatment, the rate of allergen-specific sensitization (specific IgE and SPT reactivity) was comparable in the treatment and the placebo group. However, verum-treated patients displayed a significant up-regulation of allergen-specific IgG (p < 0.05). Furthermore, IL10-dependent inhibition (p < 0.05) was observed in vitro in the treatment group but not in the placebo group. CONCLUSION: Preventive SLIT is safe in children 2-5 yr of age and induces regulatory mechanisms involving allergen-specific IgG and IL10. Based on this pilot study, large-scale trials will need to investigate the modulation of sensitization and clinically relevant allergy.
BACKGROUND: Prevention of new IgE sensitizations has been described during allergen-specific immunotherapy. However, prospective data using a preventive approach in very young children who would benefit most are missing. We initiated a prospective pilot study investigating the safety, immunomodulatory, and sensitization-preventive effect of sublingual immunotherapy (SLIT) in mono/oligoclonally sensitized, clinically asymptomatic children 2-5 yr of age. METHODS: In this double-blinded, randomized, placebo-controlled pilot study, 31 mono-/oligosensitized children to house-dust mite or grass pollen were included. SLIT with the respective source (n = 15) or placebo (n = 16) was applied. After dose-up-phase therapy was continued for 2 yr. Parents recorded clinical events, vaccinations, and drug intake in a diary. Skin prick testing and specific IgE and IgG measurements were recorded at baseline, 12 and 24 months. At the same time, allergen-specific proliferation and IL10- and TGFβ-dependent Treg function were measured. RESULTS: Preventive application of SLIT in young children was safe (no relevant side effects in 21,170 single applications). After 12 and 24 months of treatment, the rate of allergen-specific sensitization (specific IgE and SPT reactivity) was comparable in the treatment and the placebo group. However, verum-treated patients displayed a significant up-regulation of allergen-specific IgG (p < 0.05). Furthermore, IL10-dependent inhibition (p < 0.05) was observed in vitro in the treatment group but not in the placebo group. CONCLUSION: Preventive SLIT is safe in children 2-5 yr of age and induces regulatory mechanisms involving allergen-specific IgG and IL10. Based on this pilot study, large-scale trials will need to investigate the modulation of sensitization and clinically relevant allergy.
Authors: F Purello-D'Ambrosio; S Gangemi; R A Merendino; S Isola; P Puccinelli; S Parmiani; L Ricciardi Journal: Clin Exp Allergy Date: 2001-08 Impact factor: 5.018
Authors: E Dehlink; T Eiwegger; M Gerstmayr; E Kampl; B Bohle; K-W Chen; S Vrtala; R Urbanek; Z Szépfalusi Journal: Clin Exp Allergy Date: 2006-01 Impact factor: 5.018
Authors: S R Durham; S M Walker; E M Varga; M R Jacobson; F O'Brien; W Noble; S J Till; Q A Hamid; K T Nouri-Aria Journal: N Engl J Med Date: 1999-08-12 Impact factor: 91.245
Authors: V Di Rienzo; F Marcucci; P Puccinelli; S Parmiani; F Frati; L Sensi; G W Canonica; G Passalacqua Journal: Clin Exp Allergy Date: 2003-02 Impact factor: 5.018
Authors: G W Canonica; C Bachert; P Hellings; D Ryan; E Valovirta; M Wickman; O De Beaumont; J Bousquet Journal: World Allergy Organ J Date: 2015-11-10 Impact factor: 4.084
Authors: Inna Tulaeva; Bernhard Kratzer; Raffaela Campana; Mirela Curin; Marianne van Hage; Antonina Karsonova; Ksenja Riabova; Alexander Karaulov; Musa Khaitov; Winfried F Pickl; Rudolf Valenta Journal: Front Immunol Date: 2020-07-07 Impact factor: 7.561