Asthma
Conditions
Interventions
Subcutaneous vaccination with PROLINEM DS (Dermatophagoides siboney allergen vaccine adjuvanted with Neisseria meningitidis proteoliposome).
Schedule:
Time 0: 0.25 mL of excipient solution
30 minutes:
Sponsors
National Center of Bioproducts (BioCen)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion 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
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. 11. Lack of patient cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Score of expected adverse events (allergic) and frequency of systemic reactions[ Rating expected adverse events (EAE): 10-point scale (1 = systemic reactions Grade 0, 2 = Local, 3 =Systemic Grade I, 4 = Systemic Grade II 7 = Systemic Grade III, 10 = Systemic Grade IV EAE: cumulative sum by the patient during the treatment or cross sum between patients receiving the same dose (to compare different dose tolerability). Frequency of systemic reactions: number of systemic reactions Grade I-IV divided by the number of injections]. Measuring time: daily for 84 days after the first injection. 2. Clinical respiratory symptoms and need for medication rating [Symptoms (shortness of breath, cough, sputum, wheezing and chest tightness). Each symptom 1 point, maximum of 5 points per day. Points will be added by the intensity 0: symptoms disappear spontaneously, 1: If necessary self-administered home therapy (tablets, syrups and sprays pressurized bronchodilators), 2: If the patient will need to attend the consultation of the research team or the emergency guard of any instance, 3: If the patient requires hospitalization. Need medication Scoring: 3-point scale (0 = no use, 1 = use of beta-2 agonists, methylxanthines, ephedrine, adrenaline, 2 = use of corticosteroids). The compound variable of symptoms and medication will be calculated as the simple sum of both scores]. Measuring time: daily, pre-treatment and for 84 days. 3. Expiratory lung function [spirometry forced technique with portable spirometer (DATOSPIR-70). Determine the Forced Vital Capacity (FVC), and Forced Expiratory Volume in one second (FEV1). Both are expressed as a percentage of the theoretical reference value calculated according to body weight of the patient]. Measuring time: pre-treatment, on days 1, 14, 28, 42, 56, 70 and 84. 4. Allergen-specific skin reactivity [Ch10, allergen concentration equivalent to a wheal area equal to that produced by histamine HCl 10 mg / mL]. Measuring time: Pretreatment, | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vital Signs (blood pressure, cardiac frequency, body temperature (axillary) and respiratory frequency).Measuring time: days 1, 14, 28, 42, 56, 70 and 84. 2. Clinical laboratory (CBC with differential, glucose, creatinine, erythrocyte sedimentation rate, total and direct bilirubin, total protein, hematocrit, platelet count total, glutamic pyruvic transaminase (GPT) and glutamic oxaloacetic (GOT), virus antigens Hepatitis B). Measuring time: Pretreatment, and 42 and 84 days after the first injection. | — |
Countries
Cuba
Contacts
Public ContactMary Reyes Zamora
National Center of Bioproducts (BIOCEN), Allergen Department
Outcome results
None listed