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

Conditions

• Immunization

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Accepted

Interventions

• Exercise — BEHAVIORAL
  90 minute exercise session

Study Details

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.

Key Dates

Start date

Mar 1, 2021

Status verified

Aug 2023

Primary completion

Sep 30, 2025

Completion

Sep 30, 2026

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• 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.

Primary Outcome Measure

Change in Serum antibody [ Time Frame: Pre-immunization, and at 2 weeks following the initial immunization, approximately one month, three, six, and twelve months after the initial vaccine ]

Central Contacts

• Marian Kohut, PhD
  5152948364
  [email protected]
• Kaitlyn Holden, PhD
  5152948364
  [email protected]

Locations (1)

Find similar trials in Ames, IA

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