Evaluation of the safety, tolerability and immunogenicity of therapeutic allergens vaccine Dermatophagoides siboney adjuvanted proteoliposome of Neisseria meningitidis in asthmatic patients sensitive to this mite (Version 04). - SCIT- PROLIMEM-DS- Asthma-Adults-Phase I

ational Center of Bioproducts (BioCen)0 个研究点目标入组 20 人开始时间: 2013年1月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Allergic asthmatic patients with a positive history of allergic symptoms caused by house dust, according to questionnaire
•2. Positive skin test to Dermatophagoides siboney with wheal diameter greater than or equal to 3 mm and less than or equal to 7 mm (VALERGEN-DS 20 000 BU / mL) and negative skin test Blomia tropicalis and Dermatophagoides pteronyssinus, or positive with a diameter lower than that for DS.
•3. Patients included in the study are patients diagnosed clinically as extrinsic asthmatics, which are classified as intermittent or persistent mild or moderate according to international guidelines for asthma (GINA, Global Initiative for Asthma)
•4. Age between 18 and 45.
•5. Any gender and color skin.
•6. Patients express written consent to participate in our trial. 7.Pretreatment Supplementary examinations within the normal reference range of According to the institution.

•1. Patients previously treated with immunotherapy with allergenic extracts in the previous five years.
•2. Patients classified as severe persistent asthma.
•3. Diagnosed autoimmune disease of any kind.
•4. Generalized severe eczema.
•5. Patients with tumor disease.
•6. Patients treated with beta-blockers.
•7. Patients where the use of adrenaline is contraindicated (hypertension).
•8. Patients at least one year prior to the study required immunostimulant or immunosuppressive treatment (except corticosteroids), including interferons, cyclosporin A and natural immunomodulators (Vimang Biomodulina, etc.)
•9. Patients who have suffered from bacterial meningitis, one year prior starting treatment .
•10. Patients with a history of psychiatric disorders.
•11. Lack of patient cooperation.

发起方

ational Center of Bioproducts (BioCen)