Influenza Clinical Trial
— VICOfficial title:
The Effect of Acute Exercise on the Mobilization of SARS-CoV-2 Specific T-cells
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 25, 2022 |
Est. primary completion date | December 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - '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. Exclusion Criteria: - 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. - Individuals who pass the exclusion criteria detailed above but present with more than one of the following CVD risk factors will also be excluded from the study: family history of myocardial infarction, coronary revascularization, or sudden death before 55 years of age in father or other male first-degree relative or before 65 years of age in mother or other female first-degree relative; hypertension (systolic blood pressure of >140 mmHg or diastolic blood pressure >90 mmHg); dyslipidemia (total serum cholesterol of >200 mg/dl); pre-diabetes (fasting blood glucose of >100mg/dl but <126 mg/dl); high inflammation markers (hs-CRP>10 mg/L). |
Country | Name | City | State |
---|---|---|---|
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine IFN-? concentration after whole blood stimulation with SARS-CoV-2 peptides | Determine the differences in IFN-? concentrations via an ELISA | 1 year | |
Primary | Determine IFN-? spot forming cells after stimulation with SARS-CoV-2 peptides | Determine the differences in IFN-? spot forming cells via an ELISPOT | 1 year | |
Primary | Determine SARS-CoV-2 T-cell phenotype | DetermineSARS-CoV-2 T-cell phenotype through peripheral blood analysis | 1 year | |
Primary | Expand SARS-CoV-2 specific T-cells | Determine if exercise can enhance expansion of SARS-CoV-2 specific T-cells | 1 year | |
Primary | Determine SARS-CoV-2 T-cells TCR-ß diversity | Determine TCR-ß rearrangements specific to SARS-CoV-2 using the immunoSEQ T-MAP COVID ImmuneCODE database | 1 year |
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