Subcutaneous immunotherapy with PROLINEM -Asthma- Adults-Fase I

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

SCIT- PROLIMEM-DS- Asthma-Adults-Phase 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 this mite (Version 04).

Acronym of Scientific Title:

SCIT- PROLIMEM-DS- Asthma-Adults-Phase I

Secondary indentifying numbers:

DA-EC2012014

Issuing authority of the secondary identifying numbers:

National Center of Bioproducts (BioCen)

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

23/07/2012

Reference number:

05-007-12B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Mercedes

Midle name:

Maria

Last name:

Ronquillo Díaz

Medical Specialty :

Second Degree Specialist in Allergology.

Affiliation:

Universitary Hospital "General Calixto García"

Postal address:

Universidad Avenue y J Street

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78311508

+53-78388296

Email address:

nafemer@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Universitary Hospital "General Calixto García", November 1th, 2011

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/06/2013

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Asthma

Intervention(s):

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: 0.25 mL of 10 BU (0.2 μg Der s1) 1 hour 30 minutes: 0.15 mL of 60 UB (1.2μg Der s1) Day 14: 0.25 mL of 100 UB (2μg Der s1) Day 28: 0.5 mL of 200 UB (4μg Der s1 UB / mL)

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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, and 42 and 84 days after the first injection. 5. 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. 6. 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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

18 years

Maximum age:

45 years

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. 11. Lack of patient cooperation.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mary

Middle Name:

Carmen

Last Name:

Reyes Zamora

Specialty:

Specialist of 1st Degree in Immunology, Master in Clinical Trials

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera de Beltrán Km 1 ½

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 al 07, ext: 2100, 2101 y 2102

Email :

mary.carmen@biocen.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Raúl

Middle Name:

Lázaro

Last Name:

Castro Almarales

Specialty:

Specialist of 2nd Degree in Allergology

Affiliation:

National Center of Bioproducts (BIOCEN), Allergen Department

Postal Address:

Carretera de Beltrán Km 1 ½

City:

Bejucal, Mayabeque

País:

Cuba

Zip Code:

CP 13050, Box 6048

Telephone:

53-047-066-82201 al 07, ext: 2100, 2101 y 2102

Email :

rcastro@biocen.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000139

Date of Registration in Primary Registry:

2013-01-04

Record Verification Date:

2012-11-28 19:00

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Subcutaneous immunotherapy with PROLINEM -Asthma- Adults-Fase I

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