Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
Condition: Chronic Obstructive Pulmonary Disease; Asthma; Pneumococcal Infections
MeSH terms: Pneumococcal Infections; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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).
    

Intervention name(s): Prevenar-13; Pneumo-23
Intervention type(s): Biological; Biological
Intervention description(s): Conjugate 13 serotype pneumococcal vaccine; Polysaccharide 23-valent pneumococcal vaccine.
Other intervention name(s): PCV13; PPV23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pneumococcal vaccines