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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
View:

• Able to donate a small amount of blood,

• Planning to receive an initial mRNA Severe Acute Respiratory Distress Syndrome Coronavirus 2 vaccine,

• Between 18-64 years of age,

• Regularly participate in some form of exercise two or more times per week, including at least one session equal to or greater than 50 minutes exercise sessions or walk three or more times per week with at least one session equal to or greater than 50 minutes.

• Can safely perform 90 minutes of light to moderate intensity exercise (walk, walk/jog, or jog) based on American College of Sports Medicine exercise participation guidelines

Locations
United States
Iowa
Iowa State University
RECRUITING
Ames
Contact Information
Primary
Marian Kohut, PhD
mkohut@iastate.edu
5152948364
Backup
Kaitlyn Holden, PhD
pettinkg@iastate.edu
5152948364
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 80
Treatments
Experimental: Exercise post-immunization
After the initial mRNA-based COVID-19 vaccine is received, a supervised 90 minute light to moderate exercise session will take place.
No_intervention: Daily routine as usual (control)
After the initial mRNA-based COVID-19 vaccine is received, participants will be asked to go about their daily routine as usual, but avoid exercise for that day.
Related Therapeutic Areas
Sponsors
Leads: Iowa State University

This content was sourced from clinicaltrials.gov