Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume 129, Issue 5, Pages 1290-1296Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2012.02.026
Keywords
Intralymphatic; cat dander allergy; immunotherapy; tolerance; vaccination; Fel d 1
Categories
Funding
- ImVisioN Therapeutics AG
- Swiss National Science Foundation
- ImVisioN GmbH
- Center for Clinical Research, University Hospital Zurich
- Novartis
- PREDICTA
- MeDALL
- Global Allergy and Asthma European Network
- Christine Kuhne Center for Allergy Research and Education
- Swiss National Foundation
- European Union
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Background: Subcutaneous allergen-specific immunotherapy frequently causes allergic side effects and requires 30 to 80 injections over 3 to 5 years. Objective: We sought to improve immunotherapy by using intralymphatic allergen administration (intralymphatic immunotherapy [ILIT]) and by targeting allergen to the MHC class II pathway. Methods: Recombinant major cat dander allergen Fel d 1 was fused to a translocation sequence (TAT) and to part of the human invariant chain, generating a modular antigen transporter (MAT) vaccine (MAT-Fel d 1). In a randomized double-blind trial ILIT with MAT-Fel d 1 in alum was compared with ILIT with placebo (saline in alum) in allergic patients (ClinicalTrials.gov NCT00718679). Results: ILIT with MAT-Fel d 1 elicited no adverse events. After 3 placebo injections within 2 months, nasal tolerance increased less than 3-fold, whereas 3 intralymphatic injections with MAT-Fel d 1 increased nasal tolerance 74-fold (P < .001 vs placebo). ILIT with MAT-Fel d 1 stimulated regulatory T-cell responses (P = .026 vs placebo) and increased cat dander-specific IgG(4) levels by 5.66-fold (P = .003). The IgG(4) response positively correlated with IL-10 production (P < .001). Conclusion: In a first-in-human clinical study ILIT with MAT-Fel d 1 was safe and induced allergen tolerance after 3 injections. (J Allergy Clin Immunol 2012;129:1290-6.)
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