RecruitingNot ApplicableNCT05213000

Adjuvant Effect of Physical Exercise on Immune Response to COVID-19 Vaccination and Interactions With Stress

The Effect of Health Behavioral Variables Including Single Session Exercise Post-immunization and Psychosocial Factors on Immune Response to the Initial COVID-19 mRNA Vaccine, and Underlying Mechanisms


Sponsor

Iowa State University

Enrollment

80 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the extent to which a single session of light to moderate intensity exercise performed within 30 minutes after receiving either the initial dose of COVID-19 mRNA vaccine may modify the immune response to vaccination, and identify potential underlying mechanisms using gene expression and metabolite analysis. A secondary goal is to establish whether psychosocial factors are associated with immune response to vaccination. Participants will be randomized to either a 90-minute light to moderate intensity exercise session or daily routine as usual (no exercise) after receiving their initial COVID-19 mRNA vaccine. If assigned to exercise, the exercise will begin within 30 minutes after receiving the vaccine and will consist of a brisk walk and/or jog supervised by study personnel. Blood will be collected from participants prior the initial dose, two weeks after the initial dose, one week after the second dose if the individual receive the two-dose vaccine regiment or one month after the initial dose if the individual receives a one-dose vaccine regimen, and three, six, and 12 months following the initial dose. . Side effects will be measured for three days post-vaccination. Antibody and cell-mediated immune response to the vaccine will be measured in blood samples. Gene expression profiles will be analyzed by single cell RNA sequencing. Serum metabolites will be assessed to align with immune measures. Participants will be asked to complete surveys to measure physical activity history, psychosocial stress, resilience, and depression. The hypotheses of this study are: 1) a single session of exercise which take place shortly after receiving either the initial dose or the booster dose of COVID-19 will increase antibody and T cell response to the vaccine and will be associated with differentially expressed genes and an altered metabolite profile, and 2) higher levels of reported stress, and lower levels of resilience will be associated with a reduced antibody and T cell response to the vaccine.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Exercise for people with immunization. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise

90 minute exercise session


Locations(1)

Iowa State University

Ames, Iowa, United States

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NCT05213000


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