Subcutaneous immunotherapy with PROLINEM -Asthma- Adults-Fase I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000139
• Date of registration: 04/01/2013
• Primary sponsor: National Center of Bioproducts (BioCen)
• Public title: Subcutaneous immunotherapy with PROLINEM -Asthma- Adults-Fase I
• Scientific title: Evaluation of the safety, tolerability and immunogenicity of therapeutic allergens vaccine Dermatophagoides siboney adjuvanted proteoliposome of Neisseria meningitidis in asthmatic patients sensitive to the mite. (Version 04)
• Date of first enrolment: 10/12/2012
• Target sample size: 20
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000139-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Mary Reyes Zamora
• Affiliation: National Center of Bioproducts (BIOCEN), Allergen Department

• Name: Raúl Castro Almarales
• Affiliation: National Center of Bioproducts (BIOCEN), Allergen Department

Key inclusion & exclusion 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. Male gender and any race. 6. Patients express written consent to participate in our trial
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.

Age minimum: 18 years
Age maximum: 45 years
Gender: Male

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Therapeutic allergens vaccine of Dermatophagoides siboney adjuvanted proteoliposome of Neisseria meningitidis (PROLINEM) by subcutenous route in a schema of incremental doses using 60(1.2µg Der s1), 100(2µg Der s1) y 200(4µg Der s1 UB/mL) at 0, 14 y 28 days.

Primary Outcome(s)

Rating 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. 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. 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. 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, and 42 and 84 days after the first injection. Determination of serum antibodies [Total IgE and allergen-specific IgE, IgG, IgG1, IgG2, IgG3, IgG4, ratio IgE / IgG, IgG antibodies specific to N. meningitidis]. Measuring time: Pretreatment, and 42 and 84 days after the first injection. Allergen-specific cellular response of peripheral blood lymphocytes [Levels of secreted IL-4, IL-5, INFgamma, IL- Determination of Intracellular FOXP3 and CD25 cell markers]. Measuring time: Pretreatment, and 42 and 84 days after the first injection.

Secondary Outcome(s)

Vital Signs (blood pressure, cardiac frequency, body temperature (axillary) and respiratory frequency).Measuring time: days 1, 14, 28, 42, 56, 70 and 84. 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.

Secondary ID(s)

DA-EC2012014

Source(s) of Monetary Support

National Center of Bioproducts (BioCen) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable