CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Pneumovax 23 +2 moredrug
Likely dose
Pneumovax 23 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT02471014N/ACompleted
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The Effect of Obesity on Immune Responses to Pneumococcal Polysaccharide Vaccine, ROVE Study

University of Florida·observational·Posted Jun 12, 2015·Updated Dec 1, 2020

In Brief

An observational study evaluating Pneumovax 23, Blood tests, and 1 other intervention for Obesity. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartDec 1, 2016
Primary CompletionMar 1, 2019
Study CompletionMay 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.1 years ago

Interventions

Pneumovax 23drug

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

Blood testsother

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

Questionnairesother

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.