RPCEC00000139
Completed
Phase 1
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 sites20 target enrollmentJanuary 4, 2013
ConditionsAsthma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- ational Center of Bioproducts (BioCen)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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