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

NCT05213000 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

  • Immunization

Interventions

BEHAVIORAL

Exercise

90 minute exercise session

Sponsors & Collaborators

  • Iowa State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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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 NCT05213000 on ClinicalTrials.gov