Trial Outcomes & Findings for Systems Biology of PNEUMOVAX®23 and PREVNAR 13® (NCT NCT01307449)
NCT ID: NCT01307449
Last Updated: 2018-10-02
Results Overview
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M4.15 is reported.
COMPLETED
NA
88 participants
Day 7
2018-10-02
Participant Flow
Participant milestones
| Measure |
Older Group (60-89) PNEUMOVAX
Older Group (60-89) receiving single dose of PNEUMOVAX
|
Older Group (60-89) PREVNAR
Older Group (60-89) receiving single dose of PREVNAR
|
Younger Group (25-40) PNEUMOVAX
Younger Group (25-40) receiving single dose of PNEUMOVAX
|
Younger Group (25-40) PREVNAR
Younger Group (25-40) receiving single dose of PREVNAR
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
11
|
11
|
|
Overall Study
COMPLETED
|
32
|
33
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Older Group (60-89) PNEUMOVAX
Older Group (60-89) receiving single dose of PNEUMOVAX
|
Older Group (60-89) PREVNAR
Older Group (60-89) receiving single dose of PREVNAR
|
Younger Group (25-40) PNEUMOVAX
Younger Group (25-40) receiving single dose of PNEUMOVAX
|
Younger Group (25-40) PREVNAR
Younger Group (25-40) receiving single dose of PREVNAR
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Systems Biology of PNEUMOVAX®23 and PREVNAR 13®
Baseline characteristics by cohort
| Measure |
Older Group (60-89) PNEUMOVAX
n=33 Participants
Older Group (60-89) receiving single dose of PNEUMOVAX
|
Older Group (60-89) PREVNAR
n=33 Participants
Older Group (60-89) receiving single dose of PREVNAR
|
Younger Group (25-40) PNEUMOVAX
n=11 Participants
Younger Group (25-40) receiving single dose of PNEUMOVAX
|
Younger Group (25-40) PREVNAR
n=11 Participants
Younger Group (25-40) receiving single dose of PREVNAR
|
Total
n=88 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
88 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M4.15 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M11 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11
|
1 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select gene modules reporting on innate and adaptive responses in young and elderly vaccine recipients. Gene expression was compared between pre-vaccination baseline and post-vaccination day 7 for each subject. The number of subjects with significant (by FDR \< 0.05) positive enrichment of Monocyte Module M73 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module S3 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module S3
|
9 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module M156.0 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.0
|
28 Participants
|
25 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: One of the subjects in Young Pneumovax group is missing the baseline (day 0) sample, which makes the analysis impossible. RNA was never isolated from this time point. The participant has completed the rest of the visits, but these samples can't be used for the analysis in the absence of baseline.
Expression of select B cell modules was compared between pre-vaccination baseline and 7 days post-vaccination for each subject individually. The number of subjects with significant (by FDR \< 0.05) positive enrichment of B cell module M156.1 is reported.
Outcome measures
| Measure |
Older Group (60-89) on PNEUMOVAX
n=33 Participants
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) on PREVNAR
n=33 Participants
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) on PNEUMOVAX
n=10 Participants
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) on PREVNAR
n=11 Participants
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Number of Participants With Specific B Cell Responses at Day 7 That Correlate With the Innate Immune Signatures After PNEUMOVAX and PREVNAR - B Cell Module M156.1
|
32 Participants
|
30 Participants
|
10 Participants
|
11 Participants
|
Adverse Events
Older Group (60-89) PNEUMOVAX
Older Group (60-89) PREVNAR
Younger Group (25-40) PNEUMOVAX
Younger Group (25-40) PREVNAR
Serious adverse events
| Measure |
Older Group (60-89) PNEUMOVAX
n=33 participants at risk
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) PREVNAR
n=33 participants at risk
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) PNEUMOVAX
n=11 participants at risk
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) PREVNAR
n=11 participants at risk
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
|
Gastrointestinal disorders
Lynch syndrome
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
|
Cardiac disorders
Acute Coronary Syndrome
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
|
Renal and urinary disorders
Bladder cancer recurrence
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
Other adverse events
| Measure |
Older Group (60-89) PNEUMOVAX
n=33 participants at risk
Participants between the ages of 60-89 received single dose of PNEUMOVAX
|
Older Group (60-89) PREVNAR
n=33 participants at risk
Participants between the ages of 60-89 received single dose of PREVNAR
|
Younger Group (25-40) PNEUMOVAX
n=11 participants at risk
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
|
Younger Group (25-40) PREVNAR
n=11 participants at risk
Participants between the ages of 25-40 years received single dose of PREVNAR
|
|---|---|---|---|---|
|
Renal and urinary disorders
Hematuria
|
3.0%
1/33 • Number of events 1 • 6 months follow up (started at baseline)
|
0.00%
0/33 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
0.00%
0/11 • 6 months follow up (started at baseline)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place