Trial | NCT02787863  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Study Participants

    219
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.
Methods:

Immunoglobulin G (IgG)-antibodies against Streptococcus pneumoniae (S. pneumoniae) - solid-phase enzyme-linked immunoelectrodiffusion essay (ELISA).
General levels of Immunoglobulin A (IgA), Immunoglobulin M (IgM), IgG, Immunoglobulin E (IgE) in sera - radial immunodiffusion.
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+.
Microbiological examination of sputum.

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.
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).

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.
Gender: male/female.

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

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/%)
Health related quality of life (HRQoL): CAT-test (for Chronic obstructive pulmonary disease (COPD) patients), ACQ-5 (for asthma patients).
Study Started
Sep 06
2012
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Results Posted
Feb 25
2020
Last Update
Feb 25
2020

Biological Prevenar-13

Conjugate 13 serotype pneumococcal vaccine

  • Other names: PCV13

Biological Pneumo-23

Polysaccharide 23-valent pneumococcal vaccine.

  • Other names: PPV23

COPD with Prevenar-13 (1) Experimental

33 patients with COPD. Standard therapy with Prevenar-13.

Asthma with Prevenar 13 (2) Experimental

34 patients with asthma. Standard therapy with Prevenar 13.

COPD with Pneumo-23 (3) Experimental

25 patients with COPD. Standard therapy with Pneumo-23.

Asthma with Pneumo-23 (4) Experimental

25 patients with asthma. Standard therapy with Pneumo-23.

COPD with Pneumo-23/Prevenar-13 (5) Experimental

32 patients with COPD. Standard therapy, vaccinated with pneumococcal polysaccharide vaccine/pneumococcal conjugate vaccine (PPV23/PCV13).

Asthma with Pneumo-23/Prevenar-13 (6) Experimental

18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.

COPD with Prevenar-13/Pneumo-23 (7) Experimental

25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.

Asthma with Prevenar-13/Pneumo-23 (8) Experimental

27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.

Criteria 

Inclusion Criteria:

Individuals of both sexes from 18 years with a diagnosis of COPD or Bronchial Asthma;
The presence of signed and dated informed consent to participate in a clinical study;
The ability to perform the requirements of the Protocol;
For women of childbearing age is a negative result of a pregnancy test before vaccination.

Diagnostic criteria for:

- COPD: dyspnea: progressive (worsens over time), increases with exertion, persistent; chronic cough (may appear sporadically and may be unproductive); chronic expectoration; the impact of risk factors in the medical history (Smoking, occupational dust pollutants and chemicals); widespread wheeze on auscultation of the chest and/or distant wheezing in the chest; family history of COPD; spirometric data confirming the presence of fixed bronchial obstruction.

Exclusion Criteria:

Vaccination against pneumococcal infection in anamnesis;
Application of preparations of immune globulin or blood transfusion within last three months prior to clinical studies;
Prolonged use (more than 14 days) immunosuppressants or other immunosuppressive drugs within 6 months prior to the start of the study;
Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection;
A history or currently hematologic and other cancers;
A positive reaction for HIV infection, viral hepatitis B and hepatitis C;
The presence of respiratory, cardio-vascular insufficiency, impaired liver and kidney function, established during a physical examination at visit number 1;
Pronounced congenital defects or serious chronic diseases in the acute stage, including any clinically important exacerbation of chronic diseases of the liver, kidney, cardiovascular, nervous system, mental diseases or metabolic disorders, confirmed by the history or objective examination (pulmonary: cystic fibrosis, lung abscess, empyema, active tuberculosis; extra-pulmonary: congestive heart failure, malabsorption, chronic renal and hepatic failure, cirrhosis, malignancy, immunodeficiency, cirrhosis of the liver);
Severe allergic reactions in anamnesis, autoimmune disease;
The presence of acute infectious and/or communicable illnesses within 1 month prior to study;
History of chronic alcohol abuse and/or drug use;
Exacerbation of chronic diseases;
Breastfeeding;
Pregnancy;
Participation in any other clinical study within the last 3 months.

Summary

COPD - Prevenar-13 (1)

Asthma - Prevenar-13 (2)

COPD - Pneumo-23 (3)

Asthma - Pneumo-23 (4)

COPD - Pneumo-23/Prevenar-13 (5)

Asthma - Pneumo-23/Prevenar-13 (6)

COPD - Prevenar-13/Pneumo-23 (7)

Asthma - Prevenar-13/Pneumo-23 (8)

All Events

Event Type Organ System Event Term

Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.

Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.

COPD - Prevenar-13 (1)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

Asthma - Prevenar-13 (2)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

COPD - Pneumo-23 (3)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

Asthma - Pneumo-23 (4)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

COPD - Pneumo-23/Prevenar-13 (5)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

Asthma - Pneumo-23/Prevenar-13 (6)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

COPD - Prevenar-13/Pneumo-23 (7)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

Asthma - Prevenar-13/Pneumo-23 (8)

Without antibiotics, 1 year after vaccination

Without antibiotics, 1 year prior to vaccination

Without antibiotics, 4 years after vaccination

Without exacerbations, 1 year after vaccination

Without exacerbations, 1 year prior to vaccination

Without exacerbations, 4 years after vaccination

Without hospitalisat, 1 year after vaccination

Without hospitalisat, 1 year prior to vaccination

Without hospitalisat, 4 years after vaccination

The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation

The number of exacerbations of the underlying disease, antibiotic use and hospitalisation. The average number of exacerbations per 1 patient = total exacerbations in the group / number of patients in the group. This is not a mean value.

COPD - Prevenar-13 (9)

The number of antibiotic use (1-st year))

0.31
Events per 1 patient

The number of antibiotic use (4-th year))

1.19
Events per 1 patient

The number of antibiotic use (before vaccination)

1.66
Events per 1 patient

The number of exacerbations (1-st year)

0.41
Events per 1 patient

The number of exacerbations (4-th year)

1.16
Events per 1 patient

The number of exacerbations (before vaccination)

1.97
Events per 1 patient

The number of hospitalisation (1-st year)

0.13
Events per 1 patient

The number of hospitalisation (4-th year)

0.63
Events per 1 patient

The number of hospitalisation (before vaccination)

0.88
Events per 1 patient

Asthma - Prevenar-13 (10)

The number of antibiotic use (1-st year))

0.12
Events per 1 patient

The number of antibiotic use (4-th year))

0.69
Events per 1 patient

The number of antibiotic use (before vaccination)

1.12
Events per 1 patient

The number of exacerbations (1-st year)

0.24
Events per 1 patient

The number of exacerbations (4-th year)

0.85
Events per 1 patient

The number of exacerbations (before vaccination)

2.24
Events per 1 patient

The number of hospitalisation (1-st year)

0.03
Events per 1 patient

The number of hospitalisation (4-th year)

0.3
Events per 1 patient

The number of hospitalisation (before vaccination)

0.73
Events per 1 patient

COPD - Pneumo-23 (11)

The number of antibiotic use (1-st year))

0.3
Events per 1 patient

The number of antibiotic use (4-th year))

1.69
Events per 1 patient

The number of antibiotic use (before vaccination)

1.87
Events per 1 patient

The number of exacerbations (1-st year)

0.35
Events per 1 patient

The number of exacerbations (4-th year)

1.52
Events per 1 patient

The number of exacerbations (before vaccination)

2.13
Events per 1 patient

The number of hospitalisation (1-st year)

0.09
Events per 1 patient

The number of hospitalisation (4-th year)

0.96
Events per 1 patient

The number of hospitalisation (before vaccination)

0.87
Events per 1 patient

Asthma - Pneumo-23 (12)

The number of antibiotic use (1-st year))

0.56
Events per 1 patient

The number of antibiotic use (4-th year))

1.44
Events per 1 patient

The number of antibiotic use (before vaccination)

1.68
Events per 1 patient

The number of exacerbations (1-st year)

0.64
Events per 1 patient

The number of exacerbations (4-th year)

1.2
Events per 1 patient

The number of exacerbations (before vaccination)

2.68
Events per 1 patient

The number of hospitalisation (1-st year)

0.04
Events per 1 patient

The number of hospitalisation (4-th year)

0.56
Events per 1 patient

The number of hospitalisation (before vaccination)

0.56
Events per 1 patient

COPD - Pneumo-23/Prevenar-13 (13)

The number of antibiotic use (1-st year))

1.59
Events per 1 patient

The number of antibiotic use (4-th year))

1.0
Events per 1 patient

The number of antibiotic use (before vaccination)

1.91
Events per 1 patient

The number of exacerbations (1-st year)

2.19
Events per 1 patient

The number of exacerbations (4-th year)

1.72
Events per 1 patient

The number of exacerbations (before vaccination)

2.22
Events per 1 patient

The number of hospitalisation (1-st year)

0.47
Events per 1 patient

The number of hospitalisation (4-th year)

0.47
Events per 1 patient

The number of hospitalisation (before vaccination)

0.94
Events per 1 patient

Asthma - Pneumo-23/Prevenar-13 (14)

The number of antibiotic use (1-st year))

1.06
Events per 1 patient

The number of antibiotic use (4-th year))

1.06
Events per 1 patient

The number of antibiotic use (before vaccination)

1.72
Events per 1 patient

The number of exacerbations (1-st year)

1.22
Events per 1 patient

The number of exacerbations (4-th year)

1.0
Events per 1 patient

The number of exacerbations (before vaccination)

2.39
Events per 1 patient

The number of hospitalisation (1-st year)

0.06
Events per 1 patient

The number of hospitalisation (4-th year)

0.44
Events per 1 patient

The number of hospitalisation (before vaccination)

0.56
Events per 1 patient

COPD - Prevenar-13/Pneumo-23 (15)

The number of antibiotic use (1-st year))

0.24
Events per 1 patient

The number of antibiotic use (4-th year))

0.8
Events per 1 patient

The number of antibiotic use (before vaccination)

2.12
Events per 1 patient

The number of exacerbations (1-st year)

0.32
Events per 1 patient

The number of exacerbations (4-th year)

0.84
Events per 1 patient

The number of exacerbations (before vaccination)

2.52
Events per 1 patient

The number of hospitalisation (1-st year)

0.16
Events per 1 patient

The number of hospitalisation (4-th year)

0.2
Events per 1 patient

The number of hospitalisation (before vaccination)

0.84
Events per 1 patient

Asthma - Prevenar-13/Pneumo-23 (16)

The number of antibiotic use (1-st year))

0.48
Events per 1 patient

The number of antibiotic use (4-th year))

0.56
Events per 1 patient

The number of antibiotic use (before vaccination)

1.44
Events per 1 patient

The number of exacerbations (1-st year)

0.44
Events per 1 patient

The number of exacerbations (4-th year)

0.56
Events per 1 patient

The number of exacerbations (before vaccination)

1.89
Events per 1 patient

The number of hospitalisation (1-st year)

0.26
Events per 1 patient

The number of hospitalisation (4-th year)

0.04
Events per 1 patient

The number of hospitalisation (before vaccination)

0.48
Events per 1 patient

Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD

Seeding frequency S. pneumoniae from sputum in patients with COPD

COPD - Prevenar-13 (9)

S. pneumoniae in sputum after 1 year

2.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum after 4 years

14.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

21.0
Number of Participants with S. Pneumonia

Asthma - Prevenar-13 (10)

S. pneumoniae in sputum after 1 year

S. pneumoniae in sputum after 4 years

5.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

12.0
Number of Participants with S. Pneumonia

COPD - Pneumo-23 (11)

S. pneumoniae in sputum after 1 year

5.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum after 4 years

12.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

18.0
Number of Participants with S. Pneumonia

Asthma - Pneumo-23 (12)

S. pneumoniae in sputum after 1 year

4.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum after 4 years

6.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

10.0
Number of Participants with S. Pneumonia

COPD - Pneumo-23/Prevenar-13 (13)

S. pneumoniae in sputum after 1 year

1.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum after 4 years

10.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

18.0
Number of Participants with S. Pneumonia

Asthma - Pneumo-23/Prevenar-13 (14)

S. pneumoniae in sputum after 1 year

S. pneumoniae in sputum after 4 years

3.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

5.0
Number of Participants with S. Pneumonia

COPD - Prevenar-13/Pneumo-23 (15)

S. pneumoniae in sputum after 1 year

S. pneumoniae in sputum after 4 years

6.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

14.0
Number of Participants with S. Pneumonia

Asthma - Prevenar-13/Pneumo-23 (16)

S. pneumoniae in sputum after 1 year

S. pneumoniae in sputum after 4 years

2.0
Number of Participants with S. Pneumonia

S. pneumoniae in sputum at baseline

12.0
Number of Participants with S. Pneumonia

Average CAT (COPD) and ACQ-5 (Asthma) Score

CAT - COPD Assessment Test, min. = 0, max. = 40, higher scores mean a worse outcome. ACQ-5 - Asthma control questionnaire, min. = 0, max. = 6, higher scores mean a worse outcome.

COPD - Prevenar-13 (9)

1 year after vaccination

11.5
score on a scale (Median)
Inter-Quartile Range: 7.0 to 19.5

4 years after vaccination

18.2
score on a scale (Median)
Inter-Quartile Range: 5.0 to 32.0

Baseline

21.8
score on a scale (Median)
Inter-Quartile Range: 3.0 to 38.0

Asthma - Prevenar-13 (10)

1 year after vaccination

0.6
score on a scale (Median)
Inter-Quartile Range: 0.2 to 1.0

4 years after vaccination

0.8
score on a scale (Median)
Inter-Quartile Range: 0.4 to 1.4

Baseline

1.8
score on a scale (Median)
Inter-Quartile Range: 0.6 to 2.2

COPD - Pneumo-23 (11)

1 year after vaccination

14.0
score on a scale (Median)
Inter-Quartile Range: 6.5 to 20.0

4 years after vaccination

20.5
score on a scale (Median)
Inter-Quartile Range: 4.0 to 35.0

Baseline

22.8
score on a scale (Median)
Inter-Quartile Range: 2.0 to 37.0

Asthma - Pneumo-23 (12)

1 year after vaccination

0.8
score on a scale (Median)
Inter-Quartile Range: 0.4 to 2.0

4 years after vaccination

1.4
score on a scale (Median)
Inter-Quartile Range: 1.0 to 1.8

Baseline

2.0
score on a scale (Median)
Inter-Quartile Range: 1.4 to 2.2

COPD - Pneumo-23/Prevenar-13 (13)

1 year after vaccination

11.5
score on a scale (Median)
Inter-Quartile Range: 6.0 to 15.8

4 years after vaccination

15.1
score on a scale (Median)
Inter-Quartile Range: 4.0 to 28.0

Baseline

16.8
score on a scale (Median)
Inter-Quartile Range: 4.0 to 34.0

Asthma - Pneumo-23/Prevenar-13 (14)

1 year after vaccination

0.5
score on a scale (Median)
Inter-Quartile Range: 0.2 to 1.1

4 years after vaccination

0.8
score on a scale (Median)
Inter-Quartile Range: 0.4 to 1.35

Baseline

1.1
score on a scale (Median)
Inter-Quartile Range: 0.5 to 2.2

COPD - Prevenar-13/Pneumo-23 (15)

1 year after vaccination

11.0
score on a scale (Median)
Inter-Quartile Range: 8.0 to 20.0

4 years after vaccination

19.0
score on a scale (Median)
Inter-Quartile Range: 12.0 to 24.0

Baseline

23.4
score on a scale (Median)
Inter-Quartile Range: 3.0 to 39.0

Asthma - Prevenar-13/Pneumo-23 (16)

1 year after vaccination

0.4
score on a scale (Median)
Inter-Quartile Range: 0.2 to 0.9

4 years after vaccination

1.0
score on a scale (Median)
Inter-Quartile Range: 0.5 to 1.2

Baseline

1.6
score on a scale (Median)
Inter-Quartile Range: 0.0 to 3.6

Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination

Phagocytic index (granulocytes), phagocytic index (monocytes), activity of a spontaneous HCT test (neutrophils), activity of an induced HCT test (neutrophils), percentage of HCT-positive white blood cells in a spontaneous test. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100 (phagocytic index) The phagocytic index was calculated by counting at least 100 bacteria phagocytized by certain number of phagocytic cells/macrophages and expressed following formula (Mamnur Rashid 1997): Phagocytic index = Total no. of phagocytized bacteria /No of phagocytic cells phagocytizing bacteria. Activation index = % formazan positive cells (FPC) in NBT stimulated / % formazan positive cells (FPC) in NBT Spontaneous.

COPD - Prevenar-13 (9)

activity of an induced HCT test - 1 week

15.0
score on a scale (Mean)
Standard Deviation: 2.9

activity of an induced HCT test - 2 weeks

22.0
score on a scale (Mean)
Standard Deviation: 3.1

activity of an induced HCT test - 6 weeks

26.0
score on a scale (Mean)
Standard Deviation: 3.4

activity of an induced HCT test - baseline

11.0
score on a scale (Mean)
Standard Deviation: 3.4

activity of a spontaneous HCT test - 1 week

7.5
score on a scale (Mean)
Standard Deviation: 3.1

activity of a spontaneous HCT test - 2 weeks

12.5
score on a scale (Mean)
Standard Deviation: 4.7

activity of a spontaneous HCT test - 6 weeks

14.1
score on a scale (Mean)
Standard Deviation: 4.4

activity of a spontaneous HCT test - baseline

4.0
score on a scale (Mean)
Standard Deviation: 1.3

percentage of HCT-positive cells - 1 week

11.0
score on a scale (Mean)
Standard Deviation: 2.6

percentage of HCT-positive cells - 2 weeks

15.0
score on a scale (Mean)
Standard Deviation: 2.9

percentage of HCT-positive cells - 6 weeks

17.0
score on a scale (Mean)
Standard Deviation: 3.6

percentage of HCT-positive cells - baseline

7.0
score on a scale (Mean)
Standard Deviation: 3.2

Phagocytic index (granulocytes) - 1 week

71.0
score on a scale (Mean)
Standard Deviation: 8.2

Phagocytic index (granulocytes) - 2 weeks

84.0
score on a scale (Mean)
Standard Deviation: 3.6

Phagocytic index (granulocytes) - 6 weeks

85.0
score on a scale (Mean)
Standard Deviation: 3.2

Phagocytic index (granulocytes) - baseline

65.0
score on a scale (Mean)
Standard Deviation: 7.6

Phagocytic index (monocytes) - 1 week

74.1
score on a scale (Mean)
Standard Deviation: 4.6

Phagocytic index (monocytes) - 2 weeks

74.4
score on a scale (Mean)
Standard Deviation: 4.5

Phagocytic index (monocytes) - 6 weeks

77.3
score on a scale (Mean)
Standard Deviation: 3.7

Phagocytic index (monocytes) - baseline

72.1
score on a scale (Mean)
Standard Deviation: 5.4

COPD - Pneumo-23 (11)

activity of an induced HCT test - 1 week

10.8
score on a scale (Mean)
Standard Deviation: 2.2

activity of an induced HCT test - 2 weeks

10.4
score on a scale (Mean)
Standard Deviation: 3.3

activity of an induced HCT test - 6 weeks

10.9
score on a scale (Mean)
Standard Deviation: 3.8

activity of an induced HCT test - baseline

9.3
score on a scale (Mean)
Standard Deviation: 2.6

activity of a spontaneous HCT test - 1 week

5.0
score on a scale (Mean)
Standard Deviation: 2.3

activity of a spontaneous HCT test - 2 weeks

7.2
score on a scale (Mean)
Standard Deviation: 1.9

activity of a spontaneous HCT test - 6 weeks

6.9
score on a scale (Mean)
Standard Deviation: 1.8

activity of a spontaneous HCT test - baseline

5.0
score on a scale (Mean)
Standard Deviation: 2.2

percentage of HCT-positive cells - 1 week

7.4
score on a scale (Mean)
Standard Deviation: 2.3

percentage of HCT-positive cells - 2 weeks

7.2
score on a scale (Mean)
Standard Deviation: 1.9

percentage of HCT-positive cells - 6 weeks

6.7
score on a scale (Mean)
Standard Deviation: 1.8

percentage of HCT-positive cells - baseline

6.0
score on a scale (Mean)
Standard Deviation: 2

Phagocytic index (granulocytes) - 1 week

65.0
score on a scale (Mean)
Standard Deviation: 5.4

Phagocytic index (granulocytes) - 2 weeks

64.3
score on a scale (Mean)
Standard Deviation: 4.8

Phagocytic index (granulocytes) - 6 weeks

66.5
score on a scale (Mean)
Standard Deviation: 5.8

Phagocytic index (granulocytes) - baseline

63.0
score on a scale (Mean)
Standard Deviation: 5.5

Phagocytic index (monocytes) - 1 week

75.3
score on a scale (Mean)
Standard Deviation: 5.7

Phagocytic index (monocytes) - 2 weeks

76.3
score on a scale (Mean)
Standard Deviation: 4.1

Phagocytic index (monocytes) - 6 weeks

78.1
score on a scale (Mean)
Standard Deviation: 6.6

Phagocytic index (monocytes) - baseline

74.6
score on a scale (Mean)
Standard Deviation: 5.2

Immunophenotype of Blood Lymphocytes in Patients With COPD

Immunophenotype of blood lymphocytes in patients with COPD at baseline, 1, 2 and 6 weeks after PCV13 and PPV23 vaccination. It was pre-specified to report data from only the "COPD - Prevenar-13" and the "COPD - Pneumo-23" Arms/Groups for this Outcome Measure". This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).

COPD - Prevenar-13 (1)

CD19+, 1 week after vaccination

13.3
% of cells (Mean)
Standard Deviation: 3

CD19+, 2 weeks after vaccination

11.0
% of cells (Mean)
Standard Deviation: 2.5

CD19+, 6 weeks after vaccination

15.1
% of cells (Mean)
Standard Deviation: 3.8

CD19+, baseline

12.5
% of cells (Mean)
Standard Deviation: 3.9

CD3+, 1 week after vaccination

69.7
% of cells (Mean)
Standard Deviation: 3.8

CD3+, 2 weeks after vaccination

69.0
% of cells (Mean)
Standard Deviation: 2.8

CD3+, 6 weeks after vaccination

66.9
% of cells (Mean)
Standard Deviation: 3.7

CD3+, baseline

67.3
% of cells (Mean)
Standard Deviation: 4.8

CD3-CD16+CD56+, 1 week after vaccination

14.0
% of cells (Mean)
Standard Deviation: 3

CD3+CD16+CD56+, 1 week after vaccination

11.0
% of cells (Mean)
Standard Deviation: 4.2

CD3-CD16+CD56+, 2 weeks after vaccination

13.0
% of cells (Mean)
Standard Deviation: 3.9

CD3+CD16+CD56+, 2 weeks after vaccination

22.5
% of cells (Mean)
Standard Deviation: 7.3

CD3-CD16+CD56+, 6 weeks after vaccination

16.8
% of cells (Mean)
Standard Deviation: 3.7

CD3+CD16+CD56+, 6 weeks after vaccination

17.0
% of cells (Mean)
Standard Deviation: 5.3

CD3-CD16+CD56+, baseline

18.3
% of cells (Mean)
Standard Deviation: 3.9

CD3+CD16+CD56+, baseline

11.0
% of cells (Mean)
Standard Deviation: 3.8

CD3+CD4+, 1 week after vaccination

40.7
% of cells (Mean)
Standard Deviation: 4.5

CD3+CD4+, 2 weeks after vaccination

39.4
% of cells (Mean)
Standard Deviation: 5.8

CD3+CD4+, 6 weeks after vaccination

38.9
% of cells (Mean)
Standard Deviation: 5.4

CD3+CD4+, baseline

35.9
% of cells (Mean)
Standard Deviation: 7.6

CD3+CD8+, 1 week after vaccination

23.5
% of cells (Mean)
Standard Deviation: 3.5

CD3+CD8+, 2 weeks after vaccination

32.4
% of cells (Mean)
Standard Deviation: 5.1

CD3+CD8+, 6 weeks after vaccination

33.3
% of cells (Mean)
Standard Deviation: 5.2

CD3+CD8+, baseline

26.2
% of cells (Mean)
Standard Deviation: 6.9

CD3-HLA DR+, 1 week after vaccination

13.0
% of cells (Mean)
Standard Deviation: 3.8

CD3+HLA DR+, 1 week after vaccination

11.8
% of cells (Mean)
Standard Deviation: 4.2

CD3-HLA DR+, 2 weeks after vaccination

7.0
% of cells (Mean)
Standard Deviation: 4.9

CD3+HLA DR+, 2 weeks after vaccination

10.1
% of cells (Mean)
Standard Deviation: 3.2

CD3-HLA DR+, 6 weeks after vaccination

9.5
% of cells (Mean)
Standard Deviation: 5.1

CD3+HLA DR+, 6 weeks after vaccination

16.2
% of cells (Mean)
Standard Deviation: 4.5

CD3-HLA DR+, baseline

8.6
% of cells (Mean)
Standard Deviation: 4.2

CD3+HLA DR+, baseline

12.1
% of cells (Mean)
Standard Deviation: 3.5

COPD - Pneumo-23 (3)

CD19+, 1 week after vaccination

15.6
% of cells (Mean)
Standard Deviation: 2.7

CD19+, 2 weeks after vaccination

14.9
% of cells (Mean)
Standard Deviation: 2.9

CD19+, 6 weeks after vaccination

14.5
% of cells (Mean)
Standard Deviation: 3.1

CD19+, baseline

13.7
% of cells (Mean)
Standard Deviation: 3.3

CD3+, 1 week after vaccination

69.9
% of cells (Mean)
Standard Deviation: 6.9

CD3+, 2 weeks after vaccination

71.3
% of cells (Mean)
Standard Deviation: 5.9

CD3+, 6 weeks after vaccination

69.9
% of cells (Mean)
Standard Deviation: 6.1

CD3+, baseline

69.6
% of cells (Mean)
Standard Deviation: 5.9

CD3-CD16+CD56+, 1 week after vaccination

16.6
% of cells (Mean)
Standard Deviation: 2.2

CD3+CD16+CD56+, 1 week after vaccination

11.9
% of cells (Mean)
Standard Deviation: 2.3

CD3-CD16+CD56+, 2 weeks after vaccination

16.2
% of cells (Mean)
Standard Deviation: 2.2

CD3+CD16+CD56+, 2 weeks after vaccination

11.8
% of cells (Mean)
Standard Deviation: 2.6

CD3-CD16+CD56+, 6 weeks after vaccination

16.7
% of cells (Mean)
Standard Deviation: 2.2

CD3+CD16+CD56+, 6 weeks after vaccination

10.8
% of cells (Mean)
Standard Deviation: 2.2

CD3-CD16+CD56+, baseline

17.3
% of cells (Mean)
Standard Deviation: 2.3

CD3+CD16+CD56+, baseline

10.6
% of cells (Mean)
Standard Deviation: 2.6

CD3+CD4+, 1 week after vaccination

37.3
% of cells (Mean)
Standard Deviation: 2.7

CD3+CD4+, 2 weeks after vaccination

36.9
% of cells (Mean)
Standard Deviation: 2.8

CD3+CD4+, 6 weeks after vaccination

37.8
% of cells (Mean)
Standard Deviation: 2.5

CD3+CD4+, baseline

35.9
% of cells (Mean)
Standard Deviation: 2.2

CD3+CD8+, 1 week after vaccination

26.9
% of cells (Mean)
Standard Deviation: 2.3

CD3+CD8+, 2 weeks after vaccination

27.6
% of cells (Mean)
Standard Deviation: 1.9

CD3+CD8+, 6 weeks after vaccination

27.9
% of cells (Mean)
Standard Deviation: 1.2

CD3+CD8+, baseline

26.7
% of cells (Mean)
Standard Deviation: 2.5

CD3-HLA DR+, 1 week after vaccination

11.9
% of cells (Mean)
Standard Deviation: 2.9

CD3+HLA DR+, 1 week after vaccination

12.5
% of cells (Mean)
Standard Deviation: 1.3

CD3-HLA DR+, 2 weeks after vaccination

12.3
% of cells (Mean)
Standard Deviation: 2.4

CD3+HLA DR+, 2 weeks after vaccination

12.3
% of cells (Mean)
Standard Deviation: 1.5

CD3-HLA DR+, 6 weeks after vaccination

11.3
% of cells (Mean)
Standard Deviation: 2.9

CD3+HLA DR+, 6 weeks after vaccination

11.6
% of cells (Mean)
Standard Deviation: 1.5

CD3-HLA DR+, baseline

10.7
% of cells (Mean)
Standard Deviation: 2.9

CD3+HLA DR+, baseline

11.5
% of cells (Mean)
Standard Deviation: 1.9

IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)

IgA, IgM, IgG, IgE, circulating immune complexes (CIC) in serum at baseline, 1, 2 and 6 weeks after vaccination. It was pre-specified to report data from only the "COPD - Prevenar-13" and the "COPD - Pneumo-23" Arms/Groups for this Outcome Measure". This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3)).

COPD - Prevenar-13 (1)

CIC, 1 week after vaccination

0.086
g/l (Mean)
Standard Deviation: 0.01

CIC, 2 weeks after vaccination

0.079
g/l (Mean)
Standard Deviation: 0.015

CIC, 6 weeks after vaccination

0.073
g/l (Mean)
Standard Deviation: 0.016

CIC, baseline

0.067
g/l (Mean)
Standard Deviation: 0.02

IgA, 1 week after vaccination

3.74
g/l (Mean)
Standard Deviation: 1.25

IgA, 2 weeks after vaccination

3.79
g/l (Mean)
Standard Deviation: 1.26

IgA, 6 weeks after vaccination

3.63
g/l (Mean)
Standard Deviation: 1.13

IgA, baseline

3.57
g/l (Mean)
Standard Deviation: 1.18

IgE, 1 week after vaccination

126.0
g/l (Mean)
Standard Deviation: 87

IgE, 2 weeks after vaccination

118.0
g/l (Mean)
Standard Deviation: 74

IgE, 6 weeks after vaccination

119.0
g/l (Mean)
Standard Deviation: 51

IgE, baseline

120.0
g/l (Mean)
Standard Deviation: 42

IgG, 1 week after vaccination

12.9
g/l (Mean)
Standard Deviation: 0.8

IgG, 2 weeks after vaccination

13.4
g/l (Mean)
Standard Deviation: 1.04

IgG, 6 weeks after vaccination

13.1
g/l (Mean)
Standard Deviation: 0.57

IgG, baseline

12.8
g/l (Mean)
Standard Deviation: 1.13

IgM, 1 week after vaccination

1.25
g/l (Mean)
Standard Deviation: 0.62

IgM, 2 weeks after vaccination

1.0
g/l (Mean)
Standard Deviation: 0.17

IgM, 6 weeks after vaccination

1.0
g/l (Mean)
Standard Deviation: 0.23

IgM, baseline

1.0
g/l (Mean)
Standard Deviation: 0.21

COPD - Pneumo-23 (3)

CIC, 1 week after vaccination

0.077
g/l (Mean)
Standard Deviation: 0.01

CIC, 2 weeks after vaccination

0.08
g/l (Mean)
Standard Deviation: 0.01

CIC, 6 weeks after vaccination

0.079
g/l (Mean)
Standard Deviation: 0.01

CIC, baseline

0.073
g/l (Mean)
Standard Deviation: 0.01

IgA, 1 week after vaccination

3.39
g/l (Mean)
Standard Deviation: 0.58

IgA, 2 weeks after vaccination

3.52
g/l (Mean)
Standard Deviation: 0.58

IgA, 6 weeks after vaccination

3.56
g/l (Mean)
Standard Deviation: 0.61

IgA, baseline

3.33
g/l (Mean)
Standard Deviation: 0.55

IgE, 1 week after vaccination

118.0
g/l (Mean)
Standard Deviation: 42

IgE, 2 weeks after vaccination

120.0
g/l (Mean)
Standard Deviation: 34

IgE, 6 weeks after vaccination

120.0
g/l (Mean)
Standard Deviation: 35

IgE, baseline

120.0
g/l (Mean)
Standard Deviation: 39

IgG, 1 week after vaccination

11.7
g/l (Mean)
Standard Deviation: 2.5

IgG, 2 weeks after vaccination

11.9
g/l (Mean)
Standard Deviation: 2.5

IgG, 6 weeks after vaccination

11.8
g/l (Mean)
Standard Deviation: 2.5

IgG, baseline

11.6
g/l (Mean)
Standard Deviation: 2.5

IgM, 1 week after vaccination

1.3
g/l (Mean)
Standard Deviation: 0.47

IgM, 2 weeks after vaccination

1.3
g/l (Mean)
Standard Deviation: 0.51

IgM, 6 weeks after vaccination

1.34
g/l (Mean)
Standard Deviation: 0.49

IgM, baseline

1.26
g/l (Mean)
Standard Deviation: 0.47

CD45RO

CD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups.

COPD With Pneumo-23/Prevenar-13 (5)

CD45RO, 1 year after vaccination

0.47
U (Mean)
Standard Deviation: 0.06

CD45RO, 4 years after vaccination

0.31
U (Mean)
Standard Deviation: 0.02

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

Asthma With Pneumo-23/Prevenar-13 (6)

CD45RO, 1 year after vaccination

0.67
U (Mean)
Standard Deviation: 0.13

CD45RO, 4 years after vaccination

0.32
U (Mean)
Standard Deviation: 0.08

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

COPD With Prevenar-13 (1)

CD45RO, 1 year after vaccination

0.43
U (Mean)
Standard Deviation: 0.04

CD45RO, 4 years after vaccination

0.24
U (Mean)
Standard Deviation: 0.03

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

Asthma With Prevenar 13 (2)

CD45RO, 1 year after vaccination

0.2
U (Mean)
Standard Deviation: 0.02

CD45RO, 4 years after vaccination

0.2
U (Mean)
Standard Deviation: 0.015

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

COPD With Pneumo-23 (3)

CD45RO, 1 year after vaccination

0.1
U (Mean)
Standard Deviation: 0.01

CD45RO, 4 years after vaccination

0.05
U (Mean)
Standard Deviation: 0.01

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

Asthma With Pneumo-23 (4)

CD45RO, 1 year after vaccination

0.15
U (Mean)
Standard Deviation: 0.01

CD45RO, 4 years after vaccination

0.1
U (Mean)
Standard Deviation: 0.01

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

COPD With Prevenar-13/Pneumo-23 (7)

CD45RO, 1 year after vaccination

0.71
U (Mean)
Standard Deviation: 0.12

CD45RO, 4 years after vaccination

0.59
U (Mean)
Standard Deviation: 0.1

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

Asthma With Prevenar-13/Pneumo-23 (8)

CD45RO, 1 year after vaccination

0.73
U (Mean)
Standard Deviation: 0.15

CD45RO, 4 years after vaccination

0.59
U (Mean)
Standard Deviation: 0.12

CD45RO, baseline

0.1
U (Mean)
Standard Deviation: 0.01

Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes

Mean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination

COPD - Prevenar-13

12 months after vaccination

112.9
U/ml (Median)
Inter-Quartile Range: 69.2 to 157.1

6 months after vaccination

132.7
U/ml (Median)
Inter-Quartile Range: 88.9 to 179.9

Baseline

69.7
U/ml (Median)
Inter-Quartile Range: 40.9 to 113.1

COPD - Pneumo-23

12 months after vaccination

94.9
U/ml (Median)
Inter-Quartile Range: 48.0 to 253.1

6 months after vaccination

106.9
U/ml (Median)
Inter-Quartile Range: 52.0 to 284.5

Baseline

66.9
U/ml (Median)
Inter-Quartile Range: 44.0 to 92.1

COPD - Pneumo-23/Prevenar-13

12 months after vaccination

6 months after vaccination

119.4
U/ml (Median)
Inter-Quartile Range: 76.9 to 160.9

Baseline

87.5
U/ml (Median)
Inter-Quartile Range: 61.7 to 132.3

COPD - Prevenar-13/Pneumo-23

12 months after vaccination

136.0
U/ml (Median)
Inter-Quartile Range: 97.4 to 193.4

6 months after vaccination

142.2
U/ml (Median)
Inter-Quartile Range: 90.3 to 200.5

Baseline

88.0
U/ml (Median)
Inter-Quartile Range: 57.1 to 121.9

Total

219
Participants

Age, Continuous

56.4
years (Mean)
Standard Deviation: 12.9

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

COPD - Prevenar-13 (1)

Asthma - Prevenar-13 (2)

COPD - Pneumo-23 (3)

Asthma - Pneumo-23 (4)

COPD - Pneumo-23/Prevenar-13 (5)

Asthma - Pneumo-23/Prevenar-13 (6)

COPD - Prevenar-13/Pneumo-23 (7)

Asthma - Prevenar-13/Pneumo-23 (8)

Drop/Withdrawal Reasons

COPD - Prevenar-13 (1)

Asthma - Prevenar-13 (2)

COPD - Pneumo-23 (3)