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Effect of Obesity on Immune Response to Pneumovax 23

NCT02471014 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-12-01

Study results available
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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

Interventions

DRUG

Pneumovax 23

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

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Mark Brantly, MD · Professor of Medicine & Chief, Division of Pulmonary, Critical Care & Sleep Medicine

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-03-31
Completion
2019-05-16

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02471014 on ClinicalTrials.gov