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Systems Biology of PNEUMOVAX®23 and PREVNAR 13®

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ClinicalTrials.gov Identifier: NCT01307449
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Nadine Rouphael, Emory University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Pneumococcal Infection
Interventions Biological: PNEUMOVAX
Biological: Prevnar
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR
Hide Arm/Group Description Older Group (60-89) receiving single dose of PNEUMOVAX Older Group (60-89) receiving single dose of PREVNAR Younger Group (25-40) receiving single dose of PNEUMOVAX Younger Group (25-40) receiving single dose of PREVNAR
Period Title: Overall Study
Started 33 33 11 11
Completed 32 33 11 11
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Arm/Group Title Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR Total
Hide Arm/Group Description Older Group (60-89) receiving single dose of PNEUMOVAX Older Group (60-89) receiving single dose of PREVNAR Younger Group (25-40) receiving single dose of PNEUMOVAX Younger Group (25-40) receiving single dose of PREVNAR Total of all reporting groups
Overall Number of Baseline Participants 33 33 11 11 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 11 participants 11 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  18.2%
8
  24.2%
11
 100.0%
11
 100.0%
36
  40.9%
>=65 years
27
  81.8%
25
  75.8%
0
   0.0%
0
   0.0%
52
  59.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 11 participants 11 participants 88 participants
Female
18
  54.5%
18
  54.5%
7
  63.6%
4
  36.4%
47
  53.4%
Male
15
  45.5%
15
  45.5%
4
  36.4%
7
  63.6%
41
  46.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 11 participants 11 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.0%
1
   9.1%
0
   0.0%
2
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  21.2%
6
  18.2%
4
  36.4%
5
  45.5%
22
  25.0%
White
24
  72.7%
23
  69.7%
6
  54.5%
6
  54.5%
59
  67.0%
More than one race
1
   3.0%
3
   9.1%
0
   0.0%
0
   0.0%
4
   4.5%
Unknown or Not Reported
1
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 11 participants 11 participants 88 participants
33 33 11 11 88
1.Primary Outcome
Title Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M4.15
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
2
   6.1%
0
   0.0%
2
  18.2%
2.Primary Outcome
Title Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M11
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.0%
5
  15.2%
0
   0.0%
3
  27.3%
3.Primary Outcome
Title Number of Participants With Innate Immunity Signatures That Correlate With the Quality of Antibodies After PNEUMOVAX and PREVNAR - Monocyte Module M73
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
   9.1%
0
   0.0%
2
  18.2%
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
9
  27.3%
10
  30.3%
7
  70.0%
8
  72.7%
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
28
  84.8%
25
  75.8%
9
  90.0%
9
  81.8%
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Older Group (60-89) on PNEUMOVAX Older Group (60-89) on PREVNAR Younger Group (25-40) on PNEUMOVAX Younger Group (25-40) on PREVNAR
Hide Arm/Group Description:
Participants between the ages of 60-89 received single dose of PNEUMOVAX
Participants between the ages of 60-89 received single dose of PREVNAR
Participants between the ages of 25-40 years received single dose of PNEUMOVAX
Participants between the ages of 25-40 years received single dose of PREVNAR
Overall Number of Participants Analyzed 33 33 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
32
  97.0%
30
  90.9%
10
 100.0%
11
 100.0%
Time Frame 6 months follow up (started at baseline)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR
Hide Arm/Group Description Participants between the ages of 60-89 received single dose of PNEUMOVAX Participants between the ages of 60-89 received single dose of PREVNAR Participants between the ages of 25-40 years received single dose of PNEUMOVAX Participants between the ages of 25-40 years received single dose of PREVNAR
All-Cause Mortality
Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/33 (0.00%)      0/11 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/33 (9.09%)      2/33 (6.06%)      0/11 (0.00%)      0/11 (0.00%)    
Cardiac disorders         
Acute Coronary Syndrome *  1/33 (3.03%)  1 0/33 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
Gastrointestinal disorders         
Lynch syndrome *  1/33 (3.03%)  1 0/33 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia *  0/33 (0.00%)  0 1/33 (3.03%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident *  0/33 (0.00%)  0 1/33 (3.03%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Renal and urinary disorders         
Bladder cancer recurrence *  1/33 (3.03%)  1 0/33 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Older Group (60-89) PNEUMOVAX Older Group (60-89) PREVNAR Younger Group (25-40) PNEUMOVAX Younger Group (25-40) PREVNAR
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      0/33 (0.00%)      0/11 (0.00%)      0/11 (0.00%)    
Renal and urinary disorders         
Hematuria *  1/33 (3.03%)  1 0/33 (0.00%)  0 0/11 (0.00%)  0 0/11 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rouphael, Nadine
Organization: Emory University
Phone: 404-712-1435
Responsible Party: Nadine Rouphael, Emory University
ClinicalTrials.gov Identifier: NCT01307449     History of Changes
Other Study ID Numbers: IRB00047973
U19AI090023 ( U.S. NIH Grant/Contract )
IRB00078300 ( Other Identifier: Emory University IRB )
First Submitted: March 1, 2011
First Posted: March 3, 2011
Results First Submitted: August 24, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 2, 2018