Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology

Asthma Clinical Trial

Official title: Pathogenetic Justification and Clinical and Immunological Efficiency of Application Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology

Status Completed

Clinical Trial Summary

Goal: to to examine the formation of postvaccination immunity and evaluate the therapeutic effect of bacterial vaccines in patients with inflammation diseases of bronchopulmonary system. Objectives of the study: assessment of microbiocenosis mucous membranes of the upper respiratory tract in patients with bronchopulmonary pathology before and after use of bacterial vaccines. Identification of mayor lymphocytes subpopulations in patients in the dynamics of the vaccination process. Study the profile of humoral immune response in patients under different schemes of vaccination. Assessment of the clinic and functional status bronchopulmonary system in the immunized patients.

Clinical Trial Description

Methods:

1. Immunoglobulin G (IgG)-antibodies against Streptococcus pneumoniae (S. pneumoniae) - solid-phase enzyme-linked immunoelectrodiffusion essay (ELISA).

2. General levels of Immunoglobulin A (IgA), Immunoglobulin M (IgM), IgG, Immunoglobulin E (IgE) in sera - radial immunodiffusion.

3. Phagocytic activity (granulocytes, monocytes), nitroblue tetrazolium test; T-lymphocytes, T-helpers (cluster of differentiation, CD3+CD4+), cytotoxic T-lymphocytes (СD3+CD8+), B-lymphocytes (CD19+); NK-cells (CD3-CD16+CD56+), NKT-cells (CD3+CD16+CD56+), activated T-cells (human leucocyte antigens, CD3+HLA DR+), CD3-HLA DR+.

4. Microbiological examination of sputum.

5. Determining the clinical effectiveness of vaccination.

• the number of exacerbations of chronic bronchopulmonary pathology for the year prior to vaccination and during the first and fourth years after vaccination;

• the number of courses of antibiotic therapy a year prior to vaccination and during the first and fourth years after immunization;

• the number of hospitalizations for acute exacerbations of chronic bronchopulmonary disease during the year prior to vaccination and during the first and fourth years after immunization.

6. Method of estimating quality of life associated with health in patients with chronic bronchopulmonary pathology (asthma control questionnaire (ACQ-5), COPD assessment test (CAT)).

Characteristics of variables (arms 1-8).

1. The age of patients (years): mean (standard deviation) [min; median; max] for normally distributed variables; median [Q25; Q75] - for variables with distribution different from normal.

2. Gender: male/female.

3. Indicators of immune status

• IgG antibodies to S. pneumoniae

• IgA, g/l [0,4-3,5]

• IgM, g/l [0,7-2,8]

• IgG, g/l [8-18]

• IgE, IU/ml [< 100]

• Phagocytic index (granulocyte), % [82-90]

• Phagocytic index (monocytes), % [75-85]

• The participation rate of spontaneous NBT-test (neutrophils), % with intensity of 0.2.e. [7-14]

• The index of activity induced NBT-test (neutrophils), % if intensity >of 0.36.e. [>28]

• The percentage of NBT-positive cells in spontaneous test, % [2-19]

• Circulating immune complexes (CEC) cond. units [0,055-0,11]

• CD3+, % [55-80]

• CD3+CD4+, % [31-49]

• CD3+CD8+, % [12-30]

• CD19+, % [5-19]

• CD3-CD16+CD56+, % [6-20]

• CD3+CD16+CD56+, % [<10]

• CD3-HLA DR+, % [5-20]

• CD3+HLA DR+, % [<12]

• CD45RO. The reference value = 0,2.

4. Microbiological examination of sputum: frequency of selection of certain microorganisms are presented as absolute number of cases and % in the respective groups.

5. Evaluation of early post-vaccination period

• The General condition (satisfactory/unsatisfactory)

• Local reactions: pain (n/%), redness (n/%, cm), consolidation (n/%, cm)

• General reactions:

• Temperature 37,0-37,5 (n/%)

• Temperature of 37.6-38,5 (n/%)

• A temperature of 38.6 and > (n/%)

• Headache (n/%)

• Malaise, fatigue (n/%)

• Joint pain (n/%)

• Muscle pain (n/%)

6. Health related quality of life (HRQoL): CAT-test (for Chronic obstructive pulmonary disease (COPD) patients), ACQ-5 (for asthma patients). ;

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pneumococcal Infections
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT02787863
• Study type: Interventional
• Source: Russian Academy of Medical Sciences
• Status: Completed
• Phase: Phase 4
• Start date: September 6, 2012
• Completion date: December 31, 2016