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

NCT05213000 | Recruiting

• 1 other identifier: 21-073
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in Serum antibody

  Change in the total serum anti-receptor binding domain IgG antibody and neutralizing antibody to Severe Acute Respiratory Syndrome Coronavirus 2

  Pre-immunization, and at 2 weeks following the initial immunization, approximately one month, three, six, and twelve months after the initial vaccine

• Change in T cell response

  Antigen-specific T cell immunity

  Time frame with respect to intervention after initial COVID immunization, samples will be assessed approximately one and six months after initial vaccine.

• Change in Gene expression profile

  Differentially expressed genes between treatment groups

  Time frame if intervention after initial COVID immunization, approximately one and six months post-immunization.

• Change in Metabolites

  Metabolite profiles in serum samples will be assessed

  Serum samples collected pre-immunization, if intervention after initial vaccine, two weeks post initial dose, and approximately one month post-immunization.

Secondary Outcomes (1)

• Potential role of psychosocial factors and change in immune response

  Serum antibody samples at all time points, and T cell at one week post-immunization

Study Arms (2)

Exercise post-immunization

EXPERIMENTAL

After the initial mRNA-based COVID-19 vaccine is received, a supervised 90 minute light to moderate exercise session will take place.

Behavioral: Exercise

Daily routine as usual (control)

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

90 minute exercise session

Exercise post-immunization

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Currently pregnant
• Weigh less than 110 pounds.
• Presence of any conditions that could significantly impact the ability to exercise safely, or unable to receive the mRNA COVID-19 vaccine
• Taking medication that significantly impact immune response or the presence of an immune disorder.

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Marian Kohut, PhD

CONTACT

5152948364; mkohut@iastate.edu

Kaitlyn Holden, PhD

CONTACT

5152948364; pettinkg@iastate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: There are two arms for the initial COVID immunization. The arms are a "control" no exercise group, and an exercise treatment group.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: January 28, 2022
• Study Start: March 1, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

US (1)