A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma

Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT therapy With Acarovac® Hausstaubmilbe

开始日期2017-03-01

申办/合作机构

Klinikum der Universität zu Köln

[+1]

100 项与 HDM allergy vaccine(Allergy Therapeutics Plc) 相关的临床结果

登录后查看更多信息

100 项与 HDM allergy vaccine(Allergy Therapeutics Plc) 相关的转化医学

登录后查看更多信息

100 项与 HDM allergy vaccine(Allergy Therapeutics Plc) 相关的专利（医药）

登录后查看更多信息

项与 HDM allergy vaccine(Allergy Therapeutics Plc) 相关的文献（医药）

2023-06-15·Journal of Investigational Allergy and Clinical Immunology3区 · 医学

Comparison of Intact Allergen Extracts and Allergoids For Subcutaneous Immunotherapy: The Effect of Chemical Modification Differs Both Between Species and Between Individual Allergen Molecules

3区 · 医学

Article

作者: Ferreras, M ; Hvalsøe Meno, K ; Nedergaard Larsen, J ; Henmar, H ; Lund, L

Background: Allergen products for subcutaneous immunotherapy (SCIT) contain intact allergen extracts or chemically modified allergoids. Chemical modification was introduced to reduce allergenicity while retaining immunogenicity and thereby enable safer and more efficient allergy immunotherapy. Methods: Experimental allergoids were produced from intact allergen extract for birch, grass, and house dust mite (HDM) to evaluate the effects of chemical modification. Preparations were compared with commercial allergoids and analyzed using SDS-PAGE/immunoblotting, IgE-inhibition assays, and crossed immunoelectrophoresis (CIE). Dermatophagoides pteronyssinus (Der p) vaccines were also tested for protease activity and immunizing capacity in a mouse model. Results: The composition of IgE-binding epitopes in allergoids differed from that of intact allergen vaccines. Birch and grass allergoids produced smears of protein aggregates on SDS-PAGE, whereas intact allergen preparations showed distinct protein bands as expected. Der p allergoid vaccines, however, showed a distinct protein band corresponding to major allergen Der p 1 in both SDS-PAGE and CIE analysis, and commercial Der p allergoid vaccines showed Der p 1–related cysteine protease activity. Conclusion: Allergoids and intact allergen preparations differ with respect to the composition of IgE-binding epitopes. However, chemical cross-linking does not affect every allergen molecule to the same degree. Der p 1, for example, remains largely unmodified. Furthermore, the investigational HDM allergoid vaccines showed reduced and delayed immune responses when used for immunization of mice.

2022-12-30·Human Vaccines & Immunotherapeutics

Monitoring of molecular profiling of allergen-antibody responses in HDM-immunotherapy patients

Article

作者: Foks-Ciekalska, Aleksandra ; Bogacz- Piaseczyńska, Agnieszka ; Lata, Aleksandra ; Rosiek-Biegus, Marta ; Nittner-Marszalska, Marita ; Kopeć, Agnieszka ; Bożek, Andrzej ; Zajac, Magdalena

Among the potential hazards of HDM immunotherapy (AIT) with HDM allergenic extracts is the possible initiation of de novosensitizations caused by a lack of complementarity between a given HDM vaccine's content and a patient's molecular sensitization profile. To investigate whether immunotherapy with HDM extracts affects changes in the profile of sensitizations to allergens contained in the extract and whether neosensitizations occur. Serum samples from patients with HDM allergies (N=63) who received 1 year of treatment with subcutaneous AIT were tested for allergen-specific IgE (sIgE) reactivity to 7 microarrayed HDM allergen molecules (Der p 1, 2,10,11,23; D far 1 and 2) with ImmunoCAP. The HDM non-AIT patients (N=22) who did not receive immunotherapy constituted the study's control group. The obtained data were analysed at baseline and after 6 and 12 months. In the HDM-AIT group, no neosensitizations after 6 and 12 months of immunotherapy were reported. Conversely, in the HDM non-AIT group, only neosensitizations to Der p 10 were observed. In the study group, sIgE levels against the HDM extract of D. pteronyssinus, D. farinae, rDer p 1, rDer p 2 and Der f 2 decreased after 12 months of AIT (p< .05). SIgE levels against Der f 1, Der p 10, 11 and 23 remained unchanged in the course of 12 months of immunotherapy. In patients with allergic rhinitis with or without concomitant HDM-induced asthma treated with HDM AIT for 12 months, no neosensitizations related to the examined HDM molecules were observed.

2022-05-01·Immunity, Inflammation and Disease

Effectiveness and safety of a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid immunotherapy in adult patients with allergic asthma and rhinitis: A real‐life prospective observational study

Article

作者: Padró, Clara ; Justicia, José L. ; Gutiérrez, Diego ; Parra, Antonio ; Moreno, Francisco ; Torán‐Barona, Carla ; Rial, Manuel J. ; Roger, Albert ; Lleonart, Ramón

AbstractIntroductionAlthough clinical trials have shown the efficacy and safety of allergen‐specific immunotherapy (AIT) in the treatment of allergic asthma, there is a need for real‐life studies. We aimed to assess the effectiveness and safety of a microcrystalline tyrosine‐adjuvanted Dermatophagoides pteronyssinus allergoid (Acarovac Plus®) in patients with house dust mite (HDM)‐induced allergic asthma in a real‐life study.MethodsA subanalysis of a multicenter, prospective, observational, real‐life study. Patients with rhinitis and allergic asthma caused by HDMs were assessed before AIT with Acarovac Plus® and at 6 and 12 months after this treatment. Assessment parameters were percentage of days with asthma symptoms, percentage of days on asthma medication, classification of asthma according to Spanish guidelines for the management of asthma, asthma‐related quality of life (quality of life in adults with asthma questionnaire [QLAAQ]), perception of symptoms (visual analog scale [VAS]), and treatment satisfaction (treatment satisfaction questionnaire for medication [TSQM]). Safety was assessed by the number and severity of adverse reactions.ResultsThis subanalysis included 55 patients. Treatment with Acarovac Plus® showed significant differences in the analyzed variables when the baseline visit was compared with the 12‐month visit: reduction of the mean (SD) percentage of days with asthma symptoms (23.9 [9.2] vs. 5.1 [12.8]; p = .002), of the mean [SD] percentage of days on asthma medication (67.6 [42.9] vs. 45.1 [46.8]; p = .002), and of the percentage of patients with persistent asthma (78.2% vs. 38.9%; p = .009). Acarovac Plus® significantly improved asthma‐related quality of life, as shown by a decrease of 1.39 points in QLAAQ score at 12 months (p < .001), and in the subjective perception of symptoms on the VAS (−3.50, p < .0001). Patients showed high treatment satisfaction according to the TSQM, and it was well tolerated. No serious adverse events were reported.ConclusionsAcarovac Plus® was effective and safe for the treatment of patients with HDM‐induced allergic asthma in a real‐life study.

100 项与 HDM allergy vaccine(Allergy Therapeutics Plc) 相关的药物交易

登录后查看更多信息