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Effect of Obesity on Immune Response to Pneumovax 23 (ROVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471014
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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.


Condition or disease Intervention/treatment
Obesity Drug: Pneumovax 23 Other: Blood tests Other: Questionnaires

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Obesity on Immune Responses to Pneumococcal Polysaccharide Vaccine, ROVE Study
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : May 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: Pneumovax 23
All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Other Name: pneumococcal polysaccharide vaccine

Other: Blood tests
All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.

Other: 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.
Drug: Pneumovax 23
All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
Other Name: pneumococcal polysaccharide vaccine

Other: Blood tests
All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.

Other: 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.





Primary Outcome Measures :
  1. Anti-pneumococcal antibodies 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.

  2. Blood lab assays between the groups [ Time Frame: Changes in baseline and up to 6 weeks ]
    Total IgG titers, complete metabolic panel, and complete blood count (CBC)


Secondary Outcome Measures :
  1. UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups. [ 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.

  2. Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups. [ 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.

  3. Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups [ 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.

  4. Life Orientation Test-Revised will be used to measure a difference between the groups. [ 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.

  5. Genetic analysis [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Area County Adults residents with a diagnosis of Obesity who are otherwise healthy.
Criteria

Inclusion Criteria:

Control group

  • aged 18-35
  • BMIs between 22-25kg/m2, Obese group
  • Aged 18 - 35
  • BMIs greater than 30kg/m2, and
  • waist to hip ratio of at least 0.9 in males and at least 0.85 in females

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)

    1. Pneumonia or Previously had Pneumonia
    2. Low blood pressure or Experienced dizzy spells
    3. Significant cardiovascular disease:Recently hospitalizations deemed significant at the discretion of the Principal Investigator, or History of heart attack, or History of stroke
    4. Spleen, Splenectomy, or Damage to spleen
    5. Lung Disease or History of lung disease
    6. Kidney disease, Blood in urine, or Protein in urine
    7. Liver disease, Previous or current liver diseases such as hepatitis A, B, or C, liver cirrhosis, or autoimmune hepatitis, or Elevated AST/ALT lab test
    8. Leukopenias
    9. Hemoglobinopathies, History of sickle cell disease, or thalassemia
    10. HIV/AIDS, or a history of HIV infection
    11. Recreational IV drug use, or Intravenous drug injection predisposes users to infections, such as human immunodeficiency virus, that may alter the immune system and therefore affect the immunoglobulin response to Pneumovax23.
    12. History of IV-drug use, or IV drug use is a risk factor for HIV infection, which may change the immune response to Pneumovax 23.
    13. History of idiopathic thrombocytopenic purpura
    14. History of chronic inflammatory diseases such as rheumatoid arthritis or chronic granulomatous disease
    15. Autoimmune disease
    16. Immunodeficiencies: neutropenia, common variable immune deficiency, Bruton's X-linked agammaglobulinemia; SCID; Selective IgA deficiency; Wiskott-Aldrich Syndrome; Ataxia Telangiectasia; DiGeorge Syndrome; Chronic Granulomatous Disease; Hyper IgE Syndrome; Complement deficiencies
  • Weight

    1. Planning on losing weight within the time frame of the study
    2. Have experienced excessive weight loss or gain within two months prior to the study
    3. Planning to undergo liposuction, gastric bypass, stomach stapling, whipple procedure, or reconstructive surgery involving transplantation of adipose tissue within the study period
    4. Bodybuilder or someone who takes part in excessive weight training
  • Allergy

    1. Any severe side effects from vaccines
    2. Allergic reaction to phenol
  • Medications/Supplementations

    1. Taking any antioxidant supplements (EmergenC)
    2. Unable to refrain from antioxidant supplements throughout the duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471014


Locations
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United States, Florida
Uf Ctsi Crc
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Mark Brantly, MD Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine
Publications:
World Health Organizations (WHO). (2014)."Pneumonia: Fact sheet." Geneva (Switzerland): World Health Organization (WHO).
Merck & Co., Inc. (1986). "Highlights of Prescribing Information. Pneumovax23." Merck & Co., Inc.
Samartin, S., Chandra, R.K. (2001). "Obesity, overnutrition and the immune system." Nutrition Research 21.1-2: 243-262.
Singh, Gurmukh. (2014).
Lutgendorf, S. K., Anderson, B., Sorosky, J. I., Buller, R. E., & Lubaroff, D. M. (2000). "Interleukin-6 and use of social support in gynecologic cancer patients." International Journal of Behavioral Medicine, 7(2), 127-142.
Cohen, F., Kearney, K. A., Kemeny, M. E., & Zegans, L. S. (1989). "Acute stress, chronic stress, and immunity, and the role of optimism as a moderator." In Psychosomatic Medicine, Vol. 51, No. 2, pp. 255-255.
Cohen, S., Mamelstein, R., Kamarck, T., and Hoberman, H. (1985). "Measuring the functional components of social support." In I.G. Sarason & Sarason (Eds.), Social support: Theory, research and application.73-94.
Centers for Disease Control and Prevention (CDC). (2014).
World Health Organization. (2008). "Waist Circumference and Waist-Hip Ratio: Report of a WHO Expert Consultation." World Health Organization, 39p.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02471014    
Other Study ID Numbers: IRB201401069
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Keywords provided by University of Florida:
Pneumovax23
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs