Uf Ctsi Crc
Gainesville, Florida, 32610, United States
NCT Number: NCT02471014
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.
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Notify Me18 year–35 year
All sexes
Observational
Gainesville, Florida, 32610, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Control group
Exclusion criteria
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
All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Other names: pneumococcal polysaccharide vaccine
All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
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.
Time frame: Changes in baseline and up to 6 weeks
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Test to be performed in a research laboratory after Visits are completed
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.
University of Florida
Other
The Effect of Obesity on Immune Responses to Pneumococcal Polysaccharide Vaccine, ROVE Study
Acronym: ROVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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