Trial Outcomes & Findings for Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology (NCT NCT02787863)
NCT ID: NCT02787863
Last Updated: 2020-02-25
Results Overview
Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
219 participants
Primary outcome timeframe
Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination
Results posted on
2020-02-25
Participant Flow
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).
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.
Participant milestones
| Measure |
COPD - Prevenar-13 (1)
33 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
34 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
25 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
25
|
25
|
32
|
18
|
25
|
27
|
|
Overall Study
1 Year After Vaccination
|
32
|
33
|
23
|
25
|
32
|
18
|
25
|
27
|
|
Overall Study
4 Years After Vaccination
|
32
|
33
|
23
|
25
|
32
|
18
|
25
|
27
|
|
Overall Study
COMPLETED
|
32
|
33
|
23
|
25
|
32
|
18
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
COPD - Prevenar-13 (1)
33 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
34 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
25 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
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).
Baseline characteristics by cohort
| Measure |
COPD With Prevenar-13 (1)
n=33 Participants
33 patients with COPD. Standard therapy with Prevenar-13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
|
Asthma With Prevenar 13 (2)
n=34 Participants
34 patients with asthma. Standard therapy with Prevenar 13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
|
COPD With Pneumo-23 (3)
n=25 Participants
25 patients with COPD. Standard therapy with Pneumo-23.
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
Asthma With Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Standard therapy with Pneumo-23.
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
COPD With Pneumo-23/Prevenar-13 (5)
n=32 Participants
32 patients with COPD. Standard therapy, vaccinated with PPV23/PCV13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
Asthma With Pneumo-23/Prevenar-13 (6)
n=18 Participants
18 patients with Asthma. Standard therapy, vaccinated with PPV23/PCV13.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
COPD With Prevenar-13/Pneumo-23 (7)
n=25 Participants
25 patients with COPD. Standard therapy, vaccinated with PCV13/PPV23.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
Asthma With Prevenar-13/Pneumo-23 (8)
n=27 Participants
27 patients with Asthma. Standard therapy, vaccinated with PCV13/PPV23.
Prevenar-13: Conjugate 13 serotype pneumococcal vaccine
Pneumo-23: Polysaccharide 23-valent pneumococcal vaccine.
|
Total
n=219 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=32 Participants • 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).
|
0 Participants
n=33 Participants • 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).
|
0 Participants
n=23 Participants • 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).
|
0 Participants
n=25 Participants • 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).
|
0 Participants
n=32 Participants • 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).
|
0 Participants
n=18 Participants • 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).
|
0 Participants
n=25 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=215 Participants • 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).
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=32 Participants • 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).
|
25 Participants
n=33 Participants • 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).
|
12 Participants
n=23 Participants • 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).
|
23 Participants
n=25 Participants • 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).
|
18 Participants
n=32 Participants • 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).
|
16 Participants
n=18 Participants • 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).
|
15 Participants
n=25 Participants • 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).
|
22 Participants
n=27 Participants • 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).
|
148 Participants
n=215 Participants • 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).
|
|
Age, Categorical
>=65 years
|
15 Participants
n=32 Participants • 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).
|
8 Participants
n=33 Participants • 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).
|
11 Participants
n=23 Participants • 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).
|
2 Participants
n=25 Participants • 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).
|
14 Participants
n=32 Participants • 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).
|
2 Participants
n=18 Participants • 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).
|
10 Participants
n=25 Participants • 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).
|
5 Participants
n=27 Participants • 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).
|
67 Participants
n=215 Participants • 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).
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 8.7 • n=32 Participants • 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).
|
52.5 years
STANDARD_DEVIATION 15.3 • n=33 Participants • 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).
|
59 years
STANDARD_DEVIATION 12.4 • n=23 Participants • 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).
|
49.1 years
STANDARD_DEVIATION 13.3 • n=25 Participants • 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).
|
63.9 years
STANDARD_DEVIATION 10.9 • n=32 Participants • 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).
|
48.5 years
STANDARD_DEVIATION 14.3 • n=18 Participants • 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).
|
60.5 years
STANDARD_DEVIATION 12.1 • n=25 Participants • 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).
|
49.3 years
STANDARD_DEVIATION 15.4 • n=27 Participants • 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).
|
56.4 years
STANDARD_DEVIATION 12.9 • n=215 Participants • 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).
|
|
Sex: Female, Male
Female
|
11 Participants
n=32 Participants • 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).
|
22 Participants
n=33 Participants • 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).
|
10 Participants
n=23 Participants • 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).
|
19 Participants
n=25 Participants • 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).
|
13 Participants
n=32 Participants • 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).
|
12 Participants
n=18 Participants • 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).
|
7 Participants
n=25 Participants • 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).
|
18 Participants
n=27 Participants • 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).
|
112 Participants
n=215 Participants • 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).
|
|
Sex: Female, Male
Male
|
21 Participants
n=32 Participants • 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).
|
11 Participants
n=33 Participants • 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).
|
13 Participants
n=23 Participants • 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).
|
6 Participants
n=25 Participants • 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).
|
19 Participants
n=32 Participants • 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).
|
6 Participants
n=18 Participants • 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).
|
18 Participants
n=25 Participants • 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).
|
9 Participants
n=27 Participants • 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).
|
103 Participants
n=215 Participants • 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).
|
|
Region of Enrollment
Russia
|
32 participants
n=33 Participants
|
33 participants
n=34 Participants
|
23 participants
n=25 Participants
|
25 participants
n=25 Participants
|
32 participants
n=32 Participants
|
18 participants
n=18 Participants
|
25 participants
n=25 Participants
|
27 participants
n=27 Participants
|
215 participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccinationNumber of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=32 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=33 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=23 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
n=32 Participants
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
n=18 Participants
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
COPD - Prevenar-13/Pneumo-23 (7)
n=25 Participants
25 patients with COPD. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
Asthma - Prevenar-13/Pneumo-23 (8)
n=27 Participants
27 patients with Asthma. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without antibiotics, 1 year prior to vaccination
|
6 Participants
|
12 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without antibiotics, 4 years after vaccination
|
12 Participants
|
21 Participants
|
5 Participants
|
8 Participants
|
11 Participants
|
7 Participants
|
13 Participants
|
18 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without exacerbations, 1 year prior to vaccination
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without exacerbations, 1 year after vaccination
|
22 Participants
|
28 Participants
|
17 Participants
|
14 Participants
|
11 Participants
|
7 Participants
|
18 Participants
|
20 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without exacerbations, 4 years after vaccination
|
10 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
13 Participants
|
13 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without antibiotics, 1 year after vaccination
|
25 Participants
|
29 Participants
|
18 Participants
|
16 Participants
|
14 Participants
|
9 Participants
|
19 Participants
|
16 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without hospitalisat, 1 year prior to vaccination
|
13 Participants
|
18 Participants
|
10 Participants
|
15 Participants
|
15 Participants
|
11 Participants
|
9 Participants
|
20 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without hospitalisat, 1 year after vaccination
|
29 Participants
|
32 Participants
|
21 Participants
|
24 Participants
|
25 Participants
|
17 Participants
|
21 Participants
|
21 Participants
|
|
Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.
Without hospitalisat, 4 years after vaccination
|
24 Participants
|
27 Participants
|
13 Participants
|
16 Participants
|
21 Participants
|
14 Participants
|
23 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccinationThe 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.
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=32 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=33 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=23 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
n=32 Participants
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
n=18 Participants
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
COPD - Prevenar-13/Pneumo-23 (7)
n=25 Participants
25 patients with COPD. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
Asthma - Prevenar-13/Pneumo-23 (8)
n=27 Participants
27 patients with Asthma. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
|---|---|---|---|---|---|---|---|---|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of antibiotic use (before vaccination)
|
1.66 Events per 1 patient
|
1.12 Events per 1 patient
|
1.87 Events per 1 patient
|
1.68 Events per 1 patient
|
1.91 Events per 1 patient
|
1.72 Events per 1 patient
|
2.12 Events per 1 patient
|
1.44 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of exacerbations (before vaccination)
|
1.97 Events per 1 patient
|
2.24 Events per 1 patient
|
2.13 Events per 1 patient
|
2.68 Events per 1 patient
|
2.22 Events per 1 patient
|
2.39 Events per 1 patient
|
2.52 Events per 1 patient
|
1.89 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of exacerbations (1-st year)
|
0.41 Events per 1 patient
|
0.24 Events per 1 patient
|
0.35 Events per 1 patient
|
0.64 Events per 1 patient
|
2.19 Events per 1 patient
|
1.22 Events per 1 patient
|
0.32 Events per 1 patient
|
0.44 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of exacerbations (4-th year)
|
1.16 Events per 1 patient
|
0.85 Events per 1 patient
|
1.52 Events per 1 patient
|
1.2 Events per 1 patient
|
1.72 Events per 1 patient
|
1 Events per 1 patient
|
0.84 Events per 1 patient
|
0.56 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of antibiotic use (1-st year))
|
0.31 Events per 1 patient
|
0.12 Events per 1 patient
|
0.3 Events per 1 patient
|
0.56 Events per 1 patient
|
1.59 Events per 1 patient
|
1.06 Events per 1 patient
|
0.24 Events per 1 patient
|
0.48 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of antibiotic use (4-th year))
|
1.19 Events per 1 patient
|
0.69 Events per 1 patient
|
1.69 Events per 1 patient
|
1.44 Events per 1 patient
|
1 Events per 1 patient
|
1.06 Events per 1 patient
|
0.8 Events per 1 patient
|
0.56 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of hospitalisation (before vaccination)
|
0.88 Events per 1 patient
|
0.73 Events per 1 patient
|
0.87 Events per 1 patient
|
0.56 Events per 1 patient
|
0.94 Events per 1 patient
|
0.56 Events per 1 patient
|
0.84 Events per 1 patient
|
0.48 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of hospitalisation (1-st year)
|
0.13 Events per 1 patient
|
0.03 Events per 1 patient
|
0.09 Events per 1 patient
|
0.04 Events per 1 patient
|
0.47 Events per 1 patient
|
0.06 Events per 1 patient
|
0.16 Events per 1 patient
|
0.26 Events per 1 patient
|
|
The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation
The number of hospitalisation (4-th year)
|
0.63 Events per 1 patient
|
0.3 Events per 1 patient
|
0.96 Events per 1 patient
|
0.56 Events per 1 patient
|
0.47 Events per 1 patient
|
0.44 Events per 1 patient
|
0.2 Events per 1 patient
|
0.04 Events per 1 patient
|
SECONDARY outcome
Timeframe: Baseline, after 1 and 4 years after vaccinationSeeding frequency S. pneumoniae from sputum in patients with COPD
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=32 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=33 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=23 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
n=32 Participants
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
n=18 Participants
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
COPD - Prevenar-13/Pneumo-23 (7)
n=25 Participants
25 patients with COPD. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
Asthma - Prevenar-13/Pneumo-23 (8)
n=27 Participants
27 patients with Asthma. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
|---|---|---|---|---|---|---|---|---|
|
Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD
S. pneumoniae in sputum after 4 years
|
14 Number of Participants with S. Pneumonia
|
5 Number of Participants with S. Pneumonia
|
12 Number of Participants with S. Pneumonia
|
6 Number of Participants with S. Pneumonia
|
10 Number of Participants with S. Pneumonia
|
3 Number of Participants with S. Pneumonia
|
6 Number of Participants with S. Pneumonia
|
2 Number of Participants with S. Pneumonia
|
|
Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD
S. pneumoniae in sputum at baseline
|
21 Number of Participants with S. Pneumonia
|
12 Number of Participants with S. Pneumonia
|
18 Number of Participants with S. Pneumonia
|
10 Number of Participants with S. Pneumonia
|
18 Number of Participants with S. Pneumonia
|
5 Number of Participants with S. Pneumonia
|
14 Number of Participants with S. Pneumonia
|
12 Number of Participants with S. Pneumonia
|
|
Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD
S. pneumoniae in sputum after 1 year
|
2 Number of Participants with S. Pneumonia
|
0 Number of Participants with S. Pneumonia
|
5 Number of Participants with S. Pneumonia
|
4 Number of Participants with S. Pneumonia
|
1 Number of Participants with S. Pneumonia
|
0 Number of Participants with S. Pneumonia
|
0 Number of Participants with S. Pneumonia
|
0 Number of Participants with S. Pneumonia
|
SECONDARY outcome
Timeframe: Baseline, after 1 and 4 years after vaccinationCAT - 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.
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=32 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=33 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=23 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
n=32 Participants
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
n=18 Participants
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
COPD - Prevenar-13/Pneumo-23 (7)
n=25 Participants
25 patients with COPD. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
Asthma - Prevenar-13/Pneumo-23 (8)
n=27 Participants
27 patients with Asthma. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
|---|---|---|---|---|---|---|---|---|
|
Average CAT (COPD) and ACQ-5 (Asthma) Score
4 years after vaccination
|
18.2 score on a scale
Interval 5.0 to 32.0
|
0.8 score on a scale
Interval 0.4 to 1.4
|
20.5 score on a scale
Interval 4.0 to 35.0
|
1.4 score on a scale
Interval 1.0 to 1.8
|
15.1 score on a scale
Interval 4.0 to 28.0
|
0.8 score on a scale
Interval 0.4 to 1.35
|
19 score on a scale
Interval 12.0 to 24.0
|
1 score on a scale
Interval 0.5 to 1.2
|
|
Average CAT (COPD) and ACQ-5 (Asthma) Score
Baseline
|
21.8 score on a scale
Interval 3.0 to 38.0
|
1.8 score on a scale
Interval 0.6 to 2.2
|
22.8 score on a scale
Interval 2.0 to 37.0
|
2 score on a scale
Interval 1.4 to 2.2
|
16.8 score on a scale
Interval 4.0 to 34.0
|
1.1 score on a scale
Interval 0.5 to 2.2
|
23.4 score on a scale
Interval 3.0 to 39.0
|
1.6 score on a scale
Interval 0.0 to 3.6
|
|
Average CAT (COPD) and ACQ-5 (Asthma) Score
1 year after vaccination
|
11.5 score on a scale
Interval 7.0 to 19.5
|
0.6 score on a scale
Interval 0.2 to 1.0
|
14 score on a scale
Interval 6.5 to 20.0
|
0.8 score on a scale
Interval 0.4 to 2.0
|
11.5 score on a scale
Interval 6.0 to 15.8
|
0.5 score on a scale
Interval 0.2 to 1.1
|
11 score on a scale
Interval 8.0 to 20.0
|
0.4 score on a scale
Interval 0.2 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccinationPopulation: 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 - %.
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.
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=20 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=20 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (granulocytes) - baseline
|
65 score on a scale
Standard Deviation 7.6
|
63 score on a scale
Standard Deviation 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (granulocytes) - 1 week
|
71 score on a scale
Standard Deviation 8.2
|
65 score on a scale
Standard Deviation 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (granulocytes) - 2 weeks
|
84 score on a scale
Standard Deviation 3.6
|
64.3 score on a scale
Standard Deviation 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (granulocytes) - 6 weeks
|
85 score on a scale
Standard Deviation 3.2
|
66.5 score on a scale
Standard Deviation 5.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (monocytes) - baseline
|
72.1 score on a scale
Standard Deviation 5.4
|
74.6 score on a scale
Standard Deviation 5.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (monocytes) - 1 week
|
74.1 score on a scale
Standard Deviation 4.6
|
75.3 score on a scale
Standard Deviation 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (monocytes) - 2 weeks
|
74.4 score on a scale
Standard Deviation 4.5
|
76.3 score on a scale
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
Phagocytic index (monocytes) - 6 weeks
|
77.3 score on a scale
Standard Deviation 3.7
|
78.1 score on a scale
Standard Deviation 6.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of a spontaneous HCT test - baseline
|
4 score on a scale
Standard Deviation 1.3
|
5 score on a scale
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of a spontaneous HCT test - 1 week
|
7.5 score on a scale
Standard Deviation 3.1
|
5 score on a scale
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of a spontaneous HCT test - 2 weeks
|
12.5 score on a scale
Standard Deviation 4.7
|
7.2 score on a scale
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of a spontaneous HCT test - 6 weeks
|
14.1 score on a scale
Standard Deviation 4.4
|
6.9 score on a scale
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of an induced HCT test - baseline
|
11 score on a scale
Standard Deviation 3.4
|
9.3 score on a scale
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of an induced HCT test - 1 week
|
15 score on a scale
Standard Deviation 2.9
|
10.8 score on a scale
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of an induced HCT test - 2 weeks
|
22 score on a scale
Standard Deviation 3.1
|
10.4 score on a scale
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
activity of an induced HCT test - 6 weeks
|
26 score on a scale
Standard Deviation 3.4
|
10.9 score on a scale
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
percentage of HCT-positive cells - baseline
|
7 score on a scale
Standard Deviation 3.2
|
6 score on a scale
Standard Deviation 2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
percentage of HCT-positive cells - 1 week
|
11 score on a scale
Standard Deviation 2.6
|
7.4 score on a scale
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
percentage of HCT-positive cells - 2 weeks
|
15 score on a scale
Standard Deviation 2.9
|
7.2 score on a scale
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination
percentage of HCT-positive cells - 6 weeks
|
17 score on a scale
Standard Deviation 3.6
|
6.7 score on a scale
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccinationPopulation: CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD16+CD56+, CD3-HLA DR+, CD3+HLA DR+
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)).
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=20 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=20 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+, baseline
|
67.3 % of cells
Standard Deviation 4.8
|
69.6 % of cells
Standard Deviation 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+, 1 week after vaccination
|
69.7 % of cells
Standard Deviation 3.8
|
69.9 % of cells
Standard Deviation 6.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+, 2 weeks after vaccination
|
69 % of cells
Standard Deviation 2.8
|
71.3 % of cells
Standard Deviation 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+, 6 weeks after vaccination
|
66.9 % of cells
Standard Deviation 3.7
|
69.9 % of cells
Standard Deviation 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD4+, baseline
|
35.9 % of cells
Standard Deviation 7.6
|
35.9 % of cells
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD4+, 1 week after vaccination
|
40.7 % of cells
Standard Deviation 4.5
|
37.3 % of cells
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD4+, 2 weeks after vaccination
|
39.4 % of cells
Standard Deviation 5.8
|
36.9 % of cells
Standard Deviation 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD4+, 6 weeks after vaccination
|
38.9 % of cells
Standard Deviation 5.4
|
37.8 % of cells
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD8+, baseline
|
26.2 % of cells
Standard Deviation 6.9
|
26.7 % of cells
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD8+, 1 week after vaccination
|
23.5 % of cells
Standard Deviation 3.5
|
26.9 % of cells
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD8+, 2 weeks after vaccination
|
32.4 % of cells
Standard Deviation 5.1
|
27.6 % of cells
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD8+, 6 weeks after vaccination
|
33.3 % of cells
Standard Deviation 5.2
|
27.9 % of cells
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD19+, baseline
|
12.5 % of cells
Standard Deviation 3.9
|
13.7 % of cells
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD19+, 1 week after vaccination
|
13.3 % of cells
Standard Deviation 3
|
15.6 % of cells
Standard Deviation 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD19+, 2 weeks after vaccination
|
11 % of cells
Standard Deviation 2.5
|
14.9 % of cells
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD19+, 6 weeks after vaccination
|
15.1 % of cells
Standard Deviation 3.8
|
14.5 % of cells
Standard Deviation 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-CD16+CD56+, baseline
|
18.3 % of cells
Standard Deviation 3.9
|
17.3 % of cells
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-CD16+CD56+, 1 week after vaccination
|
14 % of cells
Standard Deviation 3
|
16.6 % of cells
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-CD16+CD56+, 2 weeks after vaccination
|
13 % of cells
Standard Deviation 3.9
|
16.2 % of cells
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-CD16+CD56+, 6 weeks after vaccination
|
16.8 % of cells
Standard Deviation 3.7
|
16.7 % of cells
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD16+CD56+, baseline
|
11 % of cells
Standard Deviation 3.8
|
10.6 % of cells
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD16+CD56+, 1 week after vaccination
|
11 % of cells
Standard Deviation 4.2
|
11.9 % of cells
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD16+CD56+, 2 weeks after vaccination
|
22.5 % of cells
Standard Deviation 7.3
|
11.8 % of cells
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+CD16+CD56+, 6 weeks after vaccination
|
17 % of cells
Standard Deviation 5.3
|
10.8 % of cells
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-HLA DR+, baseline
|
8.6 % of cells
Standard Deviation 4.2
|
10.7 % of cells
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-HLA DR+, 1 week after vaccination
|
13 % of cells
Standard Deviation 3.8
|
11.9 % of cells
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-HLA DR+, 2 weeks after vaccination
|
7 % of cells
Standard Deviation 4.9
|
12.3 % of cells
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3-HLA DR+, 6 weeks after vaccination
|
9.5 % of cells
Standard Deviation 5.1
|
11.3 % of cells
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+HLA DR+, baseline
|
12.1 % of cells
Standard Deviation 3.5
|
11.5 % of cells
Standard Deviation 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+HLA DR+, 1 week after vaccination
|
11.8 % of cells
Standard Deviation 4.2
|
12.5 % of cells
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+HLA DR+, 2 weeks after vaccination
|
10.1 % of cells
Standard Deviation 3.2
|
12.3 % of cells
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Immunophenotype of Blood Lymphocytes in Patients With COPD
CD3+HLA DR+, 6 weeks after vaccination
|
16.2 % of cells
Standard Deviation 4.5
|
11.6 % of cells
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPDIgA, 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)).
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=20 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=20 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgM, 6 weeks after vaccination
|
1 g/l
Standard Deviation 0.23
|
1.34 g/l
Standard Deviation 0.49
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgG, baseline
|
12.8 g/l
Standard Deviation 1.13
|
11.6 g/l
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgG, 1 week after vaccination
|
12.9 g/l
Standard Deviation 0.8
|
11.7 g/l
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgA, baseline
|
3.57 g/l
Standard Deviation 1.18
|
3.33 g/l
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgA, 1 week after vaccination
|
3.74 g/l
Standard Deviation 1.25
|
3.39 g/l
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgA, 2 weeks after vaccination
|
3.79 g/l
Standard Deviation 1.26
|
3.52 g/l
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgA, 6 weeks after vaccination
|
3.63 g/l
Standard Deviation 1.13
|
3.56 g/l
Standard Deviation 0.61
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgM, baseline
|
1 g/l
Standard Deviation 0.21
|
1.26 g/l
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgM, 1 week after vaccination
|
1.25 g/l
Standard Deviation 0.62
|
1.3 g/l
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgM, 2 weeks after vaccination
|
1 g/l
Standard Deviation 0.17
|
1.3 g/l
Standard Deviation 0.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgG, 2 weeks after vaccination
|
13.4 g/l
Standard Deviation 1.04
|
11.9 g/l
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgG, 6 weeks after vaccination
|
13.1 g/l
Standard Deviation 0.57
|
11.8 g/l
Standard Deviation 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgE, baseline
|
120 g/l
Standard Deviation 42
|
120 g/l
Standard Deviation 39
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgE, 1 week after vaccination
|
126 g/l
Standard Deviation 87
|
118 g/l
Standard Deviation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgE, 2 weeks after vaccination
|
118 g/l
Standard Deviation 74
|
120 g/l
Standard Deviation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
IgE, 6 weeks after vaccination
|
119 g/l
Standard Deviation 51
|
120 g/l
Standard Deviation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
CIC, baseline
|
0.067 g/l
Standard Deviation 0.02
|
0.073 g/l
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
CIC, 1 week after vaccination
|
0.086 g/l
Standard Deviation 0.01
|
0.077 g/l
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
CIC, 2 weeks after vaccination
|
0.079 g/l
Standard Deviation 0.015
|
0.08 g/l
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)
CIC, 6 weeks after vaccination
|
0.073 g/l
Standard Deviation 0.016
|
0.079 g/l
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1 and 4 years after vaccinationCD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups.
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=15 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=15 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=15 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=15 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
n=15 Participants
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
n=15 Participants
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
COPD - Prevenar-13/Pneumo-23 (7)
n=15 Participants
25 patients with COPD. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
Asthma - Prevenar-13/Pneumo-23 (8)
n=15 Participants
27 patients with Asthma. PCV13/PPV23 vaccination.
PCV13 vaccination was first, PPV23 vaccination was after 2 months after PCV13.
|
|---|---|---|---|---|---|---|---|---|
|
CD45RO
CD45RO, baseline
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
|
CD45RO
CD45RO, 1 year after vaccination
|
0.43 U
Standard Deviation 0.04
|
0.2 U
Standard Deviation 0.02
|
0.1 U
Standard Deviation 0.01
|
0.15 U
Standard Deviation 0.01
|
0.47 U
Standard Deviation 0.06
|
0.67 U
Standard Deviation 0.13
|
0.71 U
Standard Deviation 0.12
|
0.73 U
Standard Deviation 0.15
|
|
CD45RO
CD45RO, 4 years after vaccination
|
0.24 U
Standard Deviation 0.03
|
0.2 U
Standard Deviation 0.015
|
0.05 U
Standard Deviation 0.01
|
0.1 U
Standard Deviation 0.01
|
0.31 U
Standard Deviation 0.02
|
0.32 U
Standard Deviation 0.08
|
0.59 U
Standard Deviation 0.1
|
0.59 U
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, 1 and 12 months after vaccinationMean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination
Outcome measures
| Measure |
COPD - Prevenar-13 (1)
n=32 Participants
32 patients with COPD. Prevenar-13 (PCV13) vaccination.
|
Asthma - Prevenar-13 (2)
n=23 Participants
33 patients with asthma. Prevenar-13 (PCV13) vaccination.
|
COPD - Pneumo-23 (3)
n=32 Participants
23 patients with COPD. Pneumo-23 (PPV23) vaccination.
|
Asthma - Pneumo-23 (4)
n=25 Participants
25 patients with asthma. Pneumo-23 (PPV23) vaccination.
|
COPD - Pneumo-23/Prevenar-13 (5)
32 patients with COPD, PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
Asthma - Pneumo-23/Prevenar-13 (6)
18 patients with Asthma. PPV23/PCV13.
PPV23 vaccination was first, PCV13 vaccination was after 12 months after PPV23.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes
Baseline
|
69.7 U/ml
Interval 40.9 to 113.1
|
66.9 U/ml
Interval 44.0 to 92.1
|
87.5 U/ml
Interval 61.7 to 132.3
|
88 U/ml
Interval 57.1 to 121.9
|
—
|
—
|
—
|
—
|
|
Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes
6 months after vaccination
|
132.7 U/ml
Interval 88.9 to 179.9
|
106.9 U/ml
Interval 52.0 to 284.5
|
119.4 U/ml
Interval 76.9 to 160.9
|
142.2 U/ml
Interval 90.3 to 200.5
|
—
|
—
|
—
|
—
|
|
Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes
12 months after vaccination
|
112.9 U/ml
Interval 69.2 to 157.1
|
94.9 U/ml
Interval 48.0 to 253.1
|
0 U/ml
Interval 0.0 to 0.0
|
136 U/ml
Interval 97.4 to 193.4
|
—
|
—
|
—
|
—
|
Adverse Events
COPD - Prevenar-13 (1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma - Prevenar-13 (2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD - Pneumo-23 (3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma - Pneumo-23 (4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD - Pneumo-23/Prevenar-13 (5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma - Pneumo-23/Prevenar-13 (6)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD - Prevenar-13/Pneumo-23 (7)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asthma - Prevenar-13/Pneumo-23 (8)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Andrei Dmitrievich Protasov, Professor Mikhail Petrovich Kostinov
Samara State Medical University, Institute of Sera and Vaccines RAS
Phone: +79277444126
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place