Exercise for COVID-19 Immunity

(VIC Trial)

Not currently recruiting at 1 trial location

Overseen By Forrest L Baker, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Forrest Baker

Must not be taking: Ibuprofen, Aspirin, Antihistamines, others

Disqualifiers: HIV, Cardiovascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise can enhance the immune system's response to viruses, particularly COVID-19, before and after vaccination. Researchers will examine how exercise might strengthen immunity, benefiting those who can't rely solely on vaccines. Participants should be healthy and have recently received a COVID-19 vaccine or tested positive for COVID-19 and recovered. The study involves several visits for exercise tests and blood samples. It may suit those who enjoy exercise and have a clean bill of health from recent serious illnesses or conditions. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research on exercise and immunity.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking any over-the-counter medications that affect the immune system, like ibuprofen, aspirin, antihistamines, or beta-blockers, and you cannot be on any prescription medications.

What prior data suggests that exercise is safe for enhancing immunity?

Research shows that the COVID-19 vaccine under study, COH04S1, is safe for people. In earlier studies, recipients of this vaccine exhibited strong immune responses, indicating their bodies could produce proteins to fight the virus. The vaccine targets two parts of the virus, the spike and nucleocapsid proteins, which might enhance its effectiveness.

Participants in these studies did not report any unusual or severe side effects, suggesting the vaccine is safe based on current information. They generally tolerated the vaccine well, with no major safety concerns reported in the trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise for COVID-19 Immunity trial because it explores how physical activity might enhance the immune response to the COVID-19 vaccine. Unlike standard vaccines that rely solely on the body's baseline immune response, this trial investigates whether regular exercise could boost that response, potentially leading to better protection. This approach is unique as it combines vaccination with lifestyle modification, aiming to maximize the effectiveness of the vaccine in a natural way. If successful, it could open doors to more holistic strategies in disease prevention.

What evidence suggests that exercise might be an effective treatment for enhancing COVID-19 immunity?

Research shows that exercise can strengthen the immune system and help fight viruses. Studies have found that exercise increases immune cells, improving the body's ability to combat infections like COVID-19. This is especially important for individuals who might not respond well to vaccines. In this trial, participants may choose to receive the COVID-19 vaccine, which effectively prevents severe illness, hospitalization, and death. The vaccine helps the body produce antibodies and other immune responses to protect against the virus. Combining exercise with vaccination might enhance the overall immune response. ^{2 4 6 7 8}

Who Is on the Research Team?

Richard J Simpson, PhD

Principal Investigator

The University of Arizona

Forrest L Baker, PhD

Principal Investigator

The University of Arizona

Are You a Good Fit for This Trial?

Healthy volunteers aged 18-44 who are 'low risk' for exercise, have been vaccinated or recovered from COVID-19, and meet AHA/ACSM criteria can join. They'll need to commit to several visits totaling about 11.5 hours.

Inclusion Criteria

I am vaccinated for flu, chickenpox, etc., and know my COVID-19 status.

I've been vaccinated or had COVID-19 over 2 months ago and am symptom-free.

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

I have not had a common illness like a cold in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-screening and Exercise Test

Initial visit for pre-screening and VO2 max exercise test

1 day

1 visit (in-person)

Exercise and Blood Collection

Participants undergo incremental exercise trial and blood collection at multiple timepoints

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COVID-19 Vaccine
• Exercise

Trial Overview The study is testing if exercise boosts immunity against viruses like COVID-19 before and after vaccination. Participants will do an exercise test and give blood samples at different exertion levels.

How Is the Trial Designed?

Group I: Vaccine Experimental Treatment 1 Intervention

Participants who elect to receive the vaccine

Who Is Running the Clinical Trial?

Forrest Baker

Lead Sponsor

Trials

1

Recruited

30+

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04639466

A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO ... This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara ...

2. geovax.com geovax.com/investors/press-releases/geovax-achieves-significant-progress-in-next-generation-covid-19-vaccine-development-throughout-2024

GeoVax Achieves Significant Progress in Next-Generation ... This award supports a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 compared to an approved COVID-19 vaccine ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018591/

Synthetic multiantigen MVA vaccine COH04S1 and variant- ... Several studies report reduced clinical effectiveness against Omicron variants by approved COVID-19 vaccines, which were designed to elicit ...

4. cityofhope.org cityofhope.org/news/data-published-in-lancet-microbe-on-phase-1-clinical-trial

Data published in a Lancet journal on COH04S1, ... GeoVax's product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666524722000271

Safety and immunogenicity of a synthetic multiantigen ... Interpretation. COH04S1 was well tolerated and induced spike-specific and nucleocapsid-specific antibody and T-cell responses. Future evaluation of this COVID- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8906816/

Safety and immunogenicity of a synthetic multiantigen ... COH04S1 was well tolerated and induced spike-specific and nucleocapsid-specific antibody and T-cell responses. Future evaluation of this COVID- ...

7. geovax.com geovax.com/investors/press-releases/geovax-next-generation-covid-19-vaccine-demonstrates-potent-antibody-and-cellular-immunity-in-immunocompromised-patients

GeoVax Next-Generation COVID-19 Vaccine ... The Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04977024) is evaluating the safety and immunogenicity of GEO-CM04S1, compared to ...

8. nature.com nature.com/articles/s41541-022-00436-6

Synthetic multiantigen MVA vaccine COH04S1 protects ... We developed COH04S1, a synthetic multiantigen modified vaccinia Ankara-based SARS-CoV-2 vaccine that co-expresses spike and nucleocapsid antigens.