Trial Outcomes & Findings for Pneumococcal Vaccines in Patients With Asthma (NCT NCT03260790)
NCT ID: NCT03260790
Last Updated: 2021-11-05
Results Overview
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
Baseline, week 0, week 8, week 16
Results posted on
2021-11-05
Participant Flow
Participant milestones
| Measure |
PCV13 and PPSV23
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pneumococcal Vaccines in Patients With Asthma
Baseline characteristics by cohort
| Measure |
PCV13 and PPSV23
n=8 Participants
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
n=9 Participants
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 0, week 8, week 16Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Outcome measures
| Measure |
PCV13 and PPSV23
n=8 Participants
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
n=9 Participants
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
|---|---|---|
|
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
baseline
|
109.8 mcg/dL
Interval 74.3 to 141.8
|
53.9 mcg/dL
Interval 34.8 to 185.3
|
|
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
week 0
|
142.3 mcg/dL
Interval 111.7 to 194.6
|
53.9 mcg/dL
Interval 34.8 to 185.3
|
|
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
week 8
|
211.7 mcg/dL
Interval 184.6 to 271.0
|
243.3 mcg/dL
Interval 173.4 to 271.0
|
|
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
week 16
|
212.0 mcg/dL
Interval 171.1 to 257.7
|
224.8 mcg/dL
Interval 196.6 to 271.0
|
PRIMARY outcome
Timeframe: Baseline, week 0, week 8, week 16Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Outcome measures
| Measure |
PCV13 and PPSV23
n=8 Participants
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
n=9 Participants
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
|---|---|---|
|
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
week 0
|
506.3 mcg/mL.
Interval 349.6 to 670.9
|
206.8 mcg/mL.
Interval 130.1 to 323.8
|
|
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
week 8
|
502.9 mcg/mL.
Interval 369.9 to 790.5
|
449.4 mcg/mL.
Interval 338.7 to 583.4
|
|
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
baseline
|
228.0 mcg/mL.
Interval 174.2 to 362.3
|
206.8 mcg/mL.
Interval 130.1 to 323.8
|
|
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
week 16
|
534.8 mcg/mL.
Interval 325.4 to 688.4
|
485.7 mcg/mL.
Interval 321.2 to 588.6
|
PRIMARY outcome
Timeframe: Baseline, week 0, week 8, week 16Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 \& PPSV23. Measured as mcg/mL.
Outcome measures
| Measure |
PCV13 and PPSV23
n=8 Participants
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
n=9 Participants
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
|---|---|---|
|
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
baseline
|
142.4 mcg/mL
Interval 110.7 to 246.8
|
107.4 mcg/mL
Interval 92.9 to 161.8
|
|
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
week 0
|
418.9 mcg/mL
Interval 303.2 to 525.1
|
107.4 mcg/mL
Interval 92.9 to 161.8
|
|
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
week 8
|
362.8 mcg/mL
Interval 258.9 to 498.6
|
229.4 mcg/mL
Interval 162.6 to 302.2
|
|
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
week 16
|
343.7 mcg/mL
Interval 221.5 to 447.1
|
230.5 mcg/mL
Interval 149.5 to 302.1
|
PRIMARY outcome
Timeframe: Baseline, week 0, week 8, week 16Population: Baseline = For arm PPSV23 baseline is 8 weeks prior to receiving PPSV-23. For arm PCV13 and PPSV23 baseline is day of receiving PCV-13. Week 0 = day of receiving PPSV-23 for both arms. Week 8 = eight weeks after receiving PPSV-23 for both arms. Week 16 = sixteen weeks after receiving PPSV-23 for both arms.
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Outcome measures
| Measure |
PCV13 and PPSV23
n=8 Participants
Participants received PPSV23 primed with PCV13. Participants received PCV13 8 weeks prior to receiving PPSV23
PCV13: Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23: Single 0.5 ml dose of PPSV23 administered 8 weeks after receiving PCV13 via intramuscularly or subcutaneously
|
PPSV23
n=9 Participants
Participants received PPSV23 alone
PPSV23: Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
|
|---|---|---|
|
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
baseline
|
89.2 mcg/mL
Interval 64.1 to 120.9
|
74.7 mcg/mL
Interval 41.0 to 160.2
|
|
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
week 0
|
82.4 mcg/mL
Interval 56.2 to 152.4
|
74.7 mcg/mL
Interval 41.0 to 160.2
|
|
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
week 8
|
174.2 mcg/mL
Interval 92.3 to 283.4
|
220.0 mcg/mL
Interval 164.7 to 246.8
|
|
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
week 16
|
179.1 mcg/mL
Interval 96.9 to 277.0
|
184.1 mcg/mL
Interval 171.0 to 255.2
|
Adverse Events
PCV13 and PPSV23
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PPSV23
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place