Trial Outcomes & Findings for Effect of Obesity on Immune Response to Pneumovax 23 (NCT NCT02471014)
NCT ID: NCT02471014
Last Updated: 2020-12-01
Results Overview
IgG antibody titers specific for each serotype in Pneumovax 23 (i.e. 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F) will be analyzed.
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
Changes in baseline and up to 6 weeks
Results posted on
2020-12-01
Participant Flow
56 consented. 6 participants failed secondary screening during the first visit.
Participant milestones
| Measure |
Obese Individuals
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
Normal Individuals
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Obese Individuals
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
Normal Individuals
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Effect of Obesity on Immune Response to Pneumovax 23
Baseline characteristics by cohort
| Measure |
Obese Individuals
n=23 Participants
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
Normal Individuals
n=23 Participants
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
Total
n=46 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
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
23.0 years
STANDARD_DEVIATION 3.08 • n=7 Participants
|
26.0 years
STANDARD_DEVIATION 5.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in baseline and up to 6 weeksIgG antibody titers specific for each serotype in Pneumovax 23 (i.e. 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F) will be analyzed.
Outcome measures
| Measure |
Obese Individuals
n=23 Participants
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
Normal Individuals
n=23 Participants
Participants in this group will receive one 0.5mL Pneumovax23 intramuscular vaccine at baseline, four questionnaires administered at baseline, and one 50mL blood draw at baseline and one 50mL blood draw up to 6 weeks later.
Pneumovax 23: All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Blood tests: All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
Questionnaires: All participants will answer the following questionnaires:
UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups.
|
|---|---|---|
|
Anti-pneumococcal Antibodies Between the Groups
|
34.1 titer
Standard Deviation 3.51
|
19.8 titer
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: BaselineThe UCLA loneliness scale is a 20-item questionnaire, on a scale of 0-3 for each question. This questionnaire measures subjective feelings of loneliness and social isolation. Final score of 0 reflects no loneliness and 60 reflects the maximum amount of loneliness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe Perceived Stress Scale-10 is a 10-item questionnaire assessing how stressful participants perceive their lives to be. Each question is assessed on a scale of 0 to 4. Final score of 0 reflects no stress and 40 indicates maximum amount of stress.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe Interpersonal Support Evaluation List-12, a 12-item questionnaire that measures perceived social support along 3 dimensions: appraisal support (availability of someone to talk to), belonging support (availability of people to do things with), and tangible support (e.g. material aid). This is measured on a scale of 0 to 36. The greater the number the greater perceived support.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe Life Orientation Test-Revised, a 10-item scale measuring optimism versus pessimism along a continuous scale; a higher score indicates more optimism. The lowest score is 0 and the highest is 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Test to be performed in a research laboratory after Visits are completedA small amount of blood will be sent to a research laboratory for an analysis of genetic markers Specifically, we will be analyzing the the stimulator of interferon genes (STING). This will help us determine if this gene, which has been previously thought to contribute to Pneumovax efficacy, helps explain individual differences in immune response.
Outcome measures
Outcome data not reported
Adverse Events
Obese Individuals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Individuals
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