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Pneumococcal infections are a leading cause of adult and childhood hospitalization and death. It has been shown that obese individuals are at higher risk for this bacterial infection. As a result, investigators will vaccinate obese individuals to see if they are offered the same level of protection from the vaccine as normal-weight individuals. The vaccine used for this particular bacterial infection is called Pneumovax 23.
The purpose of this study is to compare how body mass index affects protection that the vaccine provides against these bacteria.
Primary Hypothesis: Levels of protection from the vaccine are no different in pre- and post- vaccination in healthy BMI individuals and obese individuals.
Study Participants: For this study, the investigators will recruit 56 participants separated into two groups. Group 1 will enroll 23 individuals with a BMI between 22 and 25. Group 2 will enroll 23 obese individuals. Study participants will be between the ages of 18-35 and in good health.
Pre-Screening: Basic eligibility will first be determined by phone or through a questionnaire. The investigators will acquire weight and height information to calculate BMI, as well as ask about any chronic health problems. At the end of the pre-screening, an email address will be requested in order to email a copy of the consent form for the participant to review before the first visit, during which the consent form will be reviewed with the participant and any questions addressed. A cell phone number will also be requested to text participant reminders the night before their appointments (visit 1 and visit 2). If the participant declines a reminder text, a reminder phone call will be set-up.
Screening: During the in-person screening, the investigators will ask several questions. Participants with chronic health problems (significant vascular disease, hepatitis, renal disease, diabetes, immunodeficiency) will be excluded. Individuals already immunized with Pneumovax23 or Prevnar (another vaccine that protects against pneumococcal infection) will also be excluded. A pregnancy test will be given to females to exclude pregnant individuals. An HbA1C (finger prick to get a drop of blood) will also be performed to exclude participants with high blood sugar levels. Physical exams will be performed and vitals will be taken on participants who pass the initial screening to help assess health.
Questionnaires will also be given at the first visit to assess stress, which has been shown to affect the ability to protect against infection.
Study Visits: All participants will receive a Pneumovax 23 vaccine, questionnaires, physical exams, and undergo 2 blood draws.
Part of the blood will be sent to a research laboratory for gene analysis. This will help us determine if certain genetic markers explain individual differences in Pneumovax 23 efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumovax 23 | Drug | All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-pneumococcal Antibodies Between the Groups | 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. | Changes in baseline and up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups. | The 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. | Baseline |
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Inclusion Criteria:
Control group
Exclusion Criteria:
Pregnancy: Pregnant, Planning to become pregnant, or Breastfeeding
Diabetes mellitus (A1C> 6.5%): Diagnosed with diabetes
Abnormal CMP and CBC values as determined by the Principal Investigator.
Inability to fast for 8 hours prior to the initial blood draw
Immunization: Immunized with Pneumovax 23, or Immunized with Prevnar
Medications:Currently taking any of the following medications or within the 4 weeks of study:
i. Immunosuppressive drugs or chemotherapeutic agents such as azathioprine, mycophenolate mofetil, TNF inhibitors, cyclosporine, methotrexate, leflunomide, cyclophosphamide, sulfasalazine, antimalarial drugs, chlorambucil, nitrogen mustard
ii. Steroids such as prednisone, cortisone, hydrocortisone
iii. Antidiabetic drugs such as metformin, insulin, glipizide, meglitinide, sulfonylurea, glimepiride, repaglinide, nateglinide
History of clinical illness (exclusion during clinic)
Weight
Allergy
Medications/Supplementations
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Area County Adults residents with a diagnosis of Obesity who are otherwise healthy.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Brantly, MD | Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uf Ctsi Crc | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32376795 | Result | Sebastian M, Hsiao CJ, Futch HS, Eisinger RS, Dumeny L, Patel S, Gobena M, Katikaneni DS, Cohen J, Carpenter AM, Spiryda L, Heldermon CD, Jin L, Brantly ML. Obesity and STING1 genotype associate with 23-valent pneumococcal vaccination efficacy. JCI Insight. 2020 May 7;5(9):e136141. doi: 10.1172/jci.insight.136141. |
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56 consented. 6 participants failed secondary screening during the first visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline population is the same.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-pneumococcal Antibodies Between the Groups | 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. | Posted | Mean | Standard Deviation | titer | Changes in baseline and up to 6 weeks |
|
4-6 weeks
No subjects experienced serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mathew Sebastian, PhD | University of Florida | 8644901978 | mathewsebastian@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2017 | Nov 4, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2017 | Nov 4, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D022242 | Pneumococcal Vaccines |
| D006403 | Hematologic Tests |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| Blood tests | Other | All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later. |
|
| Questionnaires | Other | 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. |
|
| Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups. | The 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. | Baseline |
| Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups | The 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. | Baseline |
| Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups. | The 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. | Baseline |
| Genetic Analysis | A 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. | Test to be performed in a research laboratory after Visits are completed |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups. | The 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. | Not Posted | Baseline | Participants |
| Secondary | Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups. | The 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. | Not Posted | Baseline | Participants |
| Secondary | Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups | The 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. | Not Posted | Baseline | Participants |
| Secondary | Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups. | The 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. | Not Posted | Baseline | Participants |
| Secondary | Genetic Analysis | A 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. | Not Posted | Test to be performed in a research laboratory after Visits are completed | Participants |
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045424 |
| Complex Mixtures |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |