Exercise and COVID-19 Viral T-cell Immunity

NCT05019456 | Active Not Recruiting

• 1 other identifier: 2102477676
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Viruses are a major health problem for the general public and at risk populations. Normally, detection of antibody titers is the gold standard for determining the effectiveness of the immune system following natural or vaccine caused immunization. However, determining the effectiveness of other parts of the immune system are less common due to the difficulties with testing. Furthermore, there is a critical need to address other therapies in case vaccination is not successful in immuncompromised populations. Exercise has been shown to increase the strength of the immune system against many types of viruses and therefore could be simple way to improve immunity against the COVID-19 virus. The aim of this research is to determine the effects of exercise on anti-viral immunity against many types of common viruses before and after vaccination. We hypothesize that exercise will enhance the anti-viral immunity before and after vaccination. Up to 30 healthy volunteers (age 18-44 years) will be recruited to participate in this study. For completion of Aim 1, three visits are needed totaling around 7 hours of the patient's time and for Aim 2, three visits are needed totaling around 4.5 hours of the patient's time. The initial visit will be for pre-screening and if deemed healthy enough to participate, an exercise test to determine the VO2 max of the participant will be conducted. The following visits will require a trained phlebotomist to insert an in-dwelling catheter and participants will undergo a 20-minute incremental exercise trial. Approximately 50mL of blood will be collected at four different timepoints: at rest, 60% VO2 max, 80% VO2 max, and 1-hr post-exercise. All four collected blood samples will be used to expand viral specific T-cells and compare IFN-γ rele

Conditions

COVID-19 Respiratory Infection; Influenza

Keywords

Acute Exercise; Viral Specific T-cells

Outcome Measures

Primary Outcomes (5)

• Determine IFN-γ concentration after whole blood stimulation with SARS-CoV-2 peptides

  Determine the differences in IFN-γ concentrations via an ELISA

  1 year

• Determine IFN-γ spot forming cells after stimulation with SARS-CoV-2 peptides

  Determine the differences in IFN-γ spot forming cells via an ELISPOT

  1 year

• Determine SARS-CoV-2 T-cell phenotype

  DetermineSARS-CoV-2 T-cell phenotype through peripheral blood analysis

  1 year

• Expand SARS-CoV-2 specific T-cells

  Determine if exercise can enhance expansion of SARS-CoV-2 specific T-cells

  1 year

• Determine SARS-CoV-2 T-cells TCR-β diversity

  Determine TCR-β rearrangements specific to SARS-CoV-2 using the immunoSEQ T-MAP COVID ImmuneCODE database

  1 year

Study Arms (1)

Vaccine

EXPERIMENTAL

Participants who elect to receive the vaccine

Biological: COVID-19 Vaccine

Interventions

COVID-19 Vaccine BIOLOGICAL

COVID-19 Vaccine (mRNA or J\&J)

Vaccine

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 'low risk' for submaximal exercise testing in accordance with the risk stratification guidelines published by the American Heart Association and the American College of Sports Medicine (AHA/ACSM criteria). We will also determine the participant's current vaccine status (influenza, chickenpox, etc) and COVID-19 infection status. Infection status will be determined via self-report and Spike protein IgG titer levels We will simply ask the participant (self-report) when they received the vaccine and, if they know, which vaccine they received (e.g. Moderna or Pfizer for the COVID-19 vaccine). However, only participants that have been vaccinated (1-3 weeks after second dose) or tested positive (greater than 2-months symptom free) for COVID-19 by either PCR, antigen, or antibody testing will be eligible for Aim 2. After providing informed consent, all participants will undergo a comprehensive screening procedure to ensure that AHA/ACSM criteria are met.

You may not qualify if:

• Select a condition on the ACSM-AHA pre-exercise screening questionnaire indicating that physician approval is required prior to exercise
• Current user of tobacco products or have quit within the previous 6-months
• Body mass index of \>30 kg/m2, or waist girth of \>102cm for men and \>88cm for women
• Use over-the-counter medication known to affect the immune system (i.e. regular use of ibuprofen/aspirin, anti-histamines or beta-blockers)
• chronic/debilitating arthritis
• Bedridden in the past three months
• Common illness (i.e. colds) within the past 6-weeks
• HIV, hepatitis, stroke, autoimmune disease, central or peripheral nervous disorders, blood vessel disease, cardiovascular disease (CVD), or use of any prescription medication
• Pregnant or breast-feeding; asthma, emphysema, bronchitis, kidney disease; pheochromocytoma; diabetes; overactive thyroid; history of severe anaphylactic reaction to an allergen; or are scheduled to have surgery.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

The University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (4)

• Batatinha H, Baker FL, Smith KA, Zuniga TM, Pedlar CR, Burgess SC, Katsanis E, Simpson RJ. Recent COVID-19 vaccination has minimal effects on the physiological responses to graded exercise in physically active healthy people. J Appl Physiol (1985). 2022 Feb 1;132(2):275-282. doi: 10.1152/japplphysiol.00629.2021. Epub 2021 Dec 9.

  PMID: 34882029 RESULT

• Baker FL, Smith KA, Zuniga TM, Batatinha H, Niemiro GM, Pedlar CR, Burgess SC, Katsanis E, Simpson RJ. Acute exercise increases immune responses to SARS CoV-2 in a previously infected man. Brain Behav Immun Health. 2021 Dec;18:100343. doi: 10.1016/j.bbih.2021.100343. Epub 2021 Sep 8.

  PMID: 34514439 RESULT

• Baker FL, Zuniga TM, Smith KA, Batatinha H, Kulangara TS, Seckeler MD, Burgess SC, Katsanis E, Simpson RJ. Exercise mobilizes diverse antigen specific T-cells and elevates neutralizing antibodies in humans with natural immunity to SARS CoV-2. Brain Behav Immun Health. 2023 Mar;28:100600. doi: 10.1016/j.bbih.2023.100600. Epub 2023 Jan 31.

  PMID: 36743994 RESULT

• Smith KA, Zuniga TM, Baker FL, Batatinha H, Pedlar CR, Burgess SC, Gustafson MP, Katsanis E, Simpson RJ. COVID-19 vaccination produces exercise-responsive SARS-CoV-2 specific T-cells regardless of infection history. J Sport Health Sci. 2024 Jan;13(1):99-107. doi: 10.1016/j.jshs.2023.06.006. Epub 2023 Jul 1.

  PMID: 37399887 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Richard J Simpson, PhD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

• Forrest L Baker, PhD

  The University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants who elect to receive the COVID-19 vaccine will be asked to completed an acute bout of exercise 2 weeks after their final dose.

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: March 9, 2021
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)