Effect of Obesity on Immune Response to Pneumovax 23

NCT02471014 | Completed Results

• 1 other identifier: IRB201401069
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Pneumovax23; Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• UCLA Loneliness Scale Questionnaire Will be Used to Measure a Difference Between the Groups.

  Baseline

• Perceived Stress Scale-10 Questionnaire Will be Used to Measure a Difference Between the Groups.

  Baseline

• Interpersonal Support Evaluation List-12 Will be Used to Measure a Difference Between the Groups

  Baseline

• Life Orientation Test-Revised Will be Used to Measure a Difference Between the Groups.

  Baseline

• Genetic Analysis

  Test to be performed in a research laboratory after Visits are completed

Study Arms (2)

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; Other: Blood tests; Other: Questionnaires

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; Other: Blood tests; Other: Questionnaires

Interventions

Pneumovax 23 DRUG

All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.

Also known as: pneumococcal polysaccharide vaccine

Normal Individuals; Obese Individuals

Blood tests OTHER

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

Normal Individuals; Obese Individuals

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.

Normal Individuals; Obese Individuals

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Area County Adults residents with a diagnosis of Obesity who are otherwise healthy.

You may qualify if:

• 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

You may not qualify if:

• 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
• Pneumonia or Previously had Pneumonia
• Low blood pressure or Experienced dizzy spells
• Significant cardiovascular disease:Recently hospitalizations deemed significant at the discretion of the Principal Investigator, or History of heart attack, or History of stroke
• Spleen, Splenectomy, or Damage to spleen
• Lung Disease or History of lung disease
• Kidney disease, Blood in urine, or Protein in urine

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Uf Ctsi Crc

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• 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.

  PMID: 32376795 RESULT

MeSH Terms

Conditions

Obesity

Interventions

23-valent pneumococcal capsular polysaccharide vaccine; Pneumococcal Vaccines; Hematologic Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Mathew Sebastian, PhD
• Organization: University of Florida

mathewsebastian@ufl.edu

8644901978

Study Officials

• Mark Brantly, MD

  Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: December 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: May 16, 2019
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Locations

US (1)