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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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
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:
Health related quality of life (HRQoL): CAT-test (for Chronic obstructive pulmonary disease (COPD) patients), ACQ-5 (for asthma patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar-13 | Biological | Conjugate 13 serotype pneumococcal vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (1 year prior to vaccination), 1 year after vaccination, 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. | Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | Seeding frequency S. pneumoniae from sputum in patients with COPD | Baseline, after 1 and 4 years after vaccination |
| Average CAT (COPD) and ACQ-5 (Asthma) Score |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei D Protasov, Professor | Samara State Medical University | Principal Investigator |
| Mikhael P Kostinov, Professor | Institute of Sera and Vaccines RAS, Moscow | Principal Investigator |
| Mikhael P Kostinov, Professor | Institute of Sera and Vaccines RAS, Moscow | Study Chair |
| Aleksander V Zhestkov, Professor | Samara State Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samara State Medical Univercity | Samara | Samara Oblast | 443099 | Russia | ||
| Institute of Sera and Vaccines RAS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Protasov AD. Pneumococcal vaccination in patients with chronic broncho-pulmonary disease (literature review). The Bulletin of Contemporary Clinical Medicine. 6(2): 60-65, 2013. | ||
| Result | Protasov AD, Zhestkov AV, Kostinov MP. First results of 13-valent pneumococcal conjugate vaccine treatment in patients with chronic bronchopulmonary diseases: evaluation safety and tolerability. Russian Allergology Journal 4: 18-23, 2013. | ||
| Result | Protasov AD.COMPARATIVE EVALUATION OF THE EFFECTIVENESS OF PNEUMOCOCCAL VACCINATION WITH 13-VALENT CONJUGATE AND 23-VALENT POLYSACCHARIDE VACCINE IN PATIENTS WITH COPD. Russian Allergology Journal 4: 12-17, 2014. | ||
| Result | Kostinov MP, Protasov AD, Zhestkov AV, Polishuk VB. Promising data with pneumococcal 13-valent conjugate vaccine in adult patients with chronic bronchopulmonary pathology. Pulmonology 4: 57-63, 2014 | ||
| Result | Protasov AD. Comparative evaluation of the effectiveness of vaccination against pneumococcal infection in patients with bronchial asthma with the use of 13-valent conjugate and 23-valent polysaccharide vaccine. Pulmonology. 5: 52-56, 2014 | ||
| Result | Kostinov MP, Zhestkov AV, Protasov AD, Kostinova TA, Pakhomov DV, Chebykina AV, Magarshak OO.Comparative analysis of dynamics of indicators of quality of life in patients with chronic obstructive pulmonary disease on the background of vaccination against pneumococcal disease using the 13-valent conjugate and 23-valent polysaccharide vaccine. Pulmonology 25(2): 163-166, 2015 |
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219 patients were examined and monitored for 4 years. Distributed in a row, first to the PCV13 group, then to the PPV23, PPV23/PCV13 and PCV13/PPV23 groups for COPD and asthma.
IRB approval - 05 SEP 2012 (protocol #122, Samara State Medical University). Dates of recruitment period - 06 SEP 2012 - 07 JUL 2013. FPFV - 06 SEP 2012. LPLV - 07 JUL 2017. Types of location - Samara State Medical University, Institute of Sera and Vaccines RAS (Russian Federation).
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| ID | Title | Description |
|---|---|---|
| FG000 | COPD - Prevenar-13 (1) | 33 patients with COPD. Prevenar-13 (PCV13) vaccination. |
| FG001 | Asthma - Prevenar-13 (2) | 34 patients with asthma. Prevenar-13 (PCV13) vaccination. |
| FG002 | COPD - Pneumo-23 (3) | 25 patients with COPD. Pneumo-23 (PPV23) vaccination. |
| FG003 | Asthma - Pneumo-23 (4) | 25 patients with asthma. Pneumo-23 (PPV23) vaccination. |
| FG004 | COPD - Pneumo-23/Prevenar-13 (5) | 32 patients with COPD, PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. |
| FG005 | Asthma - Pneumo-23/Prevenar-13 (6) | 18 patients with Asthma. PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. |
| FG006 | COPD - Prevenar-13/Pneumo-23 (7) | 25 patients with COPD. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. |
| FG007 | Asthma - Prevenar-13/Pneumo-23 (8) | 27 patients with Asthma. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COPD With Prevenar-13 (1) | 33 patients with COPD. Standard therapy with Prevenar-13. Prevenar-13: Conjugate 13 serotype pneumococcal vaccine |
| BG001 | Asthma With Prevenar 13 (2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 2 patients died of chronic pulmonary hypertension, 2 patients withdrawal of informed consent during 1-st year of the trial (1 subject of I group, I subject of II group, 2 subjects of III group). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination |
|
7 days after vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COPD - Prevenar-13 (1) | 32 patients with COPD. Prevenar-13 (PCV13) vaccination. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Andrei Dmitrievich Protasov, Professor Mikhail Petrovich Kostinov | Samara State Medical University, Institute of Sera and Vaccines RAS | +79277444126 | crosss82@mail.ru |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
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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. |
|
|
| Pneumo-23 | Biological | Polysaccharide 23-valent pneumococcal vaccine. |
|
|
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.
| Baseline, after 1 and 4 years after vaccination |
| 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. | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination |
| 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)). | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination |
| 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)). | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD |
| 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. | Baseline, 1 and 4 years after vaccination |
| 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 | Baseline, 1 and 12 months after vaccination |
| Moscow |
| 105064 |
| Russia |
| 27239929 | Result | Protasov AD, Kostinov MP, Zhestkov AV, Shteiner ML, Magarshak OO, Kostinova TA, Ryzhov AA, Pakhomov DV, Blagovidov DA, Panina MI. [Choice of optimal vaccination tactics against pneumococcal infection from immunological and clinical standpoints in patients with chronic obstructive pulmonary disease]. Ter Arkh. 2016;88(5):62-69. doi: 10.17116/terarkh201688562-69. Russian. |
| 29488477 | Result | Protasov AD, Zhestkov AV, Kostinov MP, Shteiner ML, Tezikov YV, Lipatov IS, Yastrebova NE, Kostinova AM, Ryzhov AA, Polishchuk VB. [Analysis of the effectiveness and long-term results of formation of adaptive immunity in the use of various medications and vaccination schemes against pneumococcal infection in patients with chronic obstructive pulmonary disease]. Ter Arkh. 2017;89(12. Vyp. 2):165-174. doi: 10.17116/terarkh20178912165-174. Russian. |
| Result | Protasov AD, Zhestkov AV, Kostinov MP, Korymasov EA, Shteyner ML, Tezikov YV, Lipatov IS, Reshetnikova VP, Lavrent'yeva NE. Long-term clinical efficacy and a possible mechanism of action of different modes of pneumococcal vaccination in asthma patients. Pulmonology 28(2): 193-199, 2018. |
| Withdrawal by Subject |
|
34 patients with asthma. Standard therapy with Prevenar 13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
| BG002 | COPD With Pneumo-23 (3) | 25 patients with COPD. Standard therapy with Pneumo-23. Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG003 | Asthma With Pneumo-23 (4) | 25 patients with asthma. Standard therapy with Pneumo-23. Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG004 | COPD With Pneumo-23/Prevenar-13 (5) | 32 patients with COPD. Standard therapy, vaccinated with PPV23/PCV13. Prevenar-13: Conjugate 13 serotype pneumococcal vaccine Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG005 | Asthma With Pneumo-23/Prevenar-13 (6) | 18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13. Prevenar-13: Conjugate 13 serotype pneumococcal vaccine Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG006 | COPD With Prevenar-13/Pneumo-23 (7) | 25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23. Prevenar-13: Conjugate 13 serotype pneumococcal vaccine Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG007 | Asthma With Prevenar-13/Pneumo-23 (8) | 27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23. Prevenar-13: Conjugate 13 serotype pneumococcal vaccine Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine. |
| BG008 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Measure Analysis Population Description: 2 patients died of chronic pulmonary hypertension, 2 patients withdrawal of informed consent during 1-st year of the trial (1 subject of I group, I subject of II group, 2 subjects of III group). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Measure Analysis Population Description: 2 patients died of chronic pulmonary hypertension, 2 patients withdrawal of informed consent during 1-st year of the trial (1 subject of I group, I subject of II group, 2 subjects of III group). | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| COPD - Pneumo-23 (3) |
23 patients with COPD. Pneumo-23 (PPV23) vaccination. |
| OG003 | Asthma - Pneumo-23 (4) | 25 patients with asthma. Pneumo-23 (PPV23) vaccination. |
| OG004 | COPD - Pneumo-23/Prevenar-13 (5) | 32 patients with COPD, PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. |
| OG005 | Asthma - Pneumo-23/Prevenar-13 (6) | 18 patients with Asthma. PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. |
| OG006 | COPD - Prevenar-13/Pneumo-23 (7) | 25 patients with COPD. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. |
| OG007 | Asthma - Prevenar-13/Pneumo-23 (8) | 27 patients with Asthma. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. |
|
|
|
| Primary | 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. | Posted | Number | Events per 1 patient | Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination |
|
|
|
|
| Secondary | Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD | Seeding frequency S. pneumoniae from sputum in patients with COPD | Posted | Number | Number of Participants with S. Pneumonia | Baseline, after 1 and 4 years after vaccination |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, after 1 and 4 years after vaccination |
|
|
|
| Secondary | 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. | 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 - %. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination |
|
|
|
| Secondary | 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)). | CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD16+CD56+, CD3-HLA DR+, CD3+HLA DR+ | Posted | Mean | Standard Deviation | % of cells | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination |
|
|
|
| Secondary | 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)). | Posted | Mean | Standard Deviation | g/l | Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | U | Baseline, 1 and 4 years after vaccination |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | U/ml | Baseline, 1 and 12 months after vaccination |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Asthma - Prevenar-13 (2) | 33 patients with asthma. Prevenar-13 (PCV13) vaccination. | 0 | 33 | 0 | 33 |
| EG002 | COPD - Pneumo-23 (3) | 23 patients with COPD. Pneumo-23 (PPV23) vaccination. | 0 | 23 | 0 | 23 |
| EG003 | Asthma - Pneumo-23 (4) | 25 patients with asthma. Pneumo-23 (PPV23) vaccination. | 0 | 25 | 0 | 25 |
| EG004 | COPD - Pneumo-23/Prevenar-13 (5) | 32 patients with COPD, PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. | 0 | 32 | 0 | 32 |
| EG005 | Asthma - Pneumo-23/Prevenar-13 (6) | 18 patients with Asthma. PPV23/PCV13. PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23. | 0 | 18 | 0 | 18 |
| EG006 | COPD - Prevenar-13/Pneumo-23 (7) | 25 patients with COPD. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. | 0 | 25 | 0 | 25 |
| EG007 | Asthma - Prevenar-13/Pneumo-23 (8) | 27 patients with Asthma. PCV13/PPV23 vaccination. PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13. | 0 | 27 | 0 | 27 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| The number of exacerbations (1-st year) |
|
| The number of exacerbations (4-th year) |
|
| The number of antibiotic use (before vaccination) |
|
| The number of antibiotic use (1-st year)) |
|
| The number of antibiotic use (4-th year)) |
|
| The number of hospitalisation (before vaccination) |
|
| The number of hospitalisation (1-st year) |
|
| The number of hospitalisation (4-th year) |
|
| S. pneumoniae in sputum after 1 year |
|
| S. pneumoniae in sputum after 4 years |
|
| 1 year after vaccination |
|
| 4 years after vaccination |
|
| Phagocytic index (granulocytes) - 2 weeks |
|
| Phagocytic index (granulocytes) - 6 weeks |
|
| Phagocytic index (monocytes) - baseline |
|
| Phagocytic index (monocytes) - 1 week |
|
| Phagocytic index (monocytes) - 2 weeks |
|
| Phagocytic index (monocytes) - 6 weeks |
|
| activity of a spontaneous HCT test - baseline |
|
| activity of a spontaneous HCT test - 1 week |
|
| activity of a spontaneous HCT test - 2 weeks |
|
| activity of a spontaneous HCT test - 6 weeks |
|
| activity of an induced HCT test - baseline |
|
| activity of an induced HCT test - 1 week |
|
| activity of an induced HCT test - 2 weeks |
|
| activity of an induced HCT test - 6 weeks |
|
| percentage of HCT-positive cells - baseline |
|
| percentage of HCT-positive cells - 1 week |
|
| percentage of HCT-positive cells - 2 weeks |
|
| percentage of HCT-positive cells - 6 weeks |
|
| CD3+, 2 weeks after vaccination |
|
| CD3+, 6 weeks after vaccination |
|
| CD3+CD4+, baseline |
|
| CD3+CD4+, 1 week after vaccination |
|
| CD3+CD4+, 2 weeks after vaccination |
|
| CD3+CD4+, 6 weeks after vaccination |
|
| CD3+CD8+, baseline |
|
| CD3+CD8+, 1 week after vaccination |
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| CD3+CD8+, 2 weeks after vaccination |
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| CD3+CD8+, 6 weeks after vaccination |
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| CD19+, baseline |
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| CD19+, 1 week after vaccination |
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| CD19+, 2 weeks after vaccination |
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| CD19+, 6 weeks after vaccination |
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| CD3-CD16+CD56+, baseline |
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| CD3-CD16+CD56+, 1 week after vaccination |
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| CD3-CD16+CD56+, 2 weeks after vaccination |
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| CD3-CD16+CD56+, 6 weeks after vaccination |
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| CD3+CD16+CD56+, baseline |
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| CD3+CD16+CD56+, 1 week after vaccination |
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| CD3+CD16+CD56+, 2 weeks after vaccination |
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| CD3+CD16+CD56+, 6 weeks after vaccination |
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| CD3-HLA DR+, baseline |
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| CD3-HLA DR+, 1 week after vaccination |
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| CD3-HLA DR+, 2 weeks after vaccination |
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| CD3-HLA DR+, 6 weeks after vaccination |
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| CD3+HLA DR+, baseline |
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| CD3+HLA DR+, 1 week after vaccination |
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| CD3+HLA DR+, 2 weeks after vaccination |
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| CD3+HLA DR+, 6 weeks after vaccination |
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| IgA, 2 weeks after vaccination |
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| IgA, 6 weeks after vaccination |
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| IgM, baseline |
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| IgM, 1 week after vaccination |
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| IgM, 2 weeks after vaccination |
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| IgM, 6 weeks after vaccination |
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| IgG, baseline |
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| IgG, 1 week after vaccination |
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| IgG, 2 weeks after vaccination |
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| IgG, 6 weeks after vaccination |
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| IgE, baseline |
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| IgE, 1 week after vaccination |
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| IgE, 2 weeks after vaccination |
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| IgE, 6 weeks after vaccination |
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| CIC, baseline |
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| CIC, 1 week after vaccination |
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| CIC, 2 weeks after vaccination |
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| CIC, 6 weeks after vaccination |
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| CD45RO, 1 year after vaccination |
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| CD45RO, 4 years after vaccination |
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| 6 months after vaccination |
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| 12 months after vaccination |
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