Effect of Obesity on Immune Response to Pneumovax 23

Completed

• Conditions: Obesity
• Interventions: Drug: Pneumovax 23; Other: Blood tests; Other: Questionnaires

• Registration Number: NCT02471014
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-12
• Study Start: 2016-12
• Primary Completion: 2019-03
• Study Completion: 2019-05-16
• Results First Submitted: 2020-04-21
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Results First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese Individuals	Pneumovax 23	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.
Obese Individuals	Blood tests	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.
Obese Individuals	Questionnaires	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	Pneumovax 23	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	Blood tests	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	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Anti-pneumococcal Antibodies Between the Groups	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.

Secondary Outcome Measures

Name	Time	Method
Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups.	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.
UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups.	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.
Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups.	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.
Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups	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.
Genetic Analysis	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.

Trial Locations

Locations (1)

Uf Ctsi Crc; 🇺🇸 Gainesville, Florida, United States