Flu Vaccine for Coronavirus Infection

Recruiting at 1 trial location

Overseen By SNP Center Inquiry

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Immunomodulatory medications

Disqualifiers: Pregnant, Lactating, Immunodeficiency, Autoimmune, others

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

Compensation: Varies

Number of Visits: 1

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the flu vaccine in individuals who have had COVID-19. Researchers aim to determine if previous COVID-19 infections, along with conditions like obesity, type 2 diabetes, or chronic fatigue, impact flu shot immunity over time. The study includes both individuals who have had COVID-19 and those who have not, providing a clearer picture of immunity differences. Suitable candidates for this trial include those who had COVID-19 at least two months ago and may have additional conditions like long-term COVID symptoms. Participants should not have received a flu vaccine in the last four months. As a Phase 2 trial, this study focuses on measuring the flu vaccine's effectiveness in an initial, smaller group, offering valuable insights into immunity.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but if you are taking immunomodulatory medications (drugs that affect the immune system), you may not be eligible to participate.

What is the safety track record for the flu shot?

Research has shown that the flu shot is generally safe for most people, including both adults and children. Many who receive the flu vaccine experience no side effects. When side effects occur, they are usually mild and resolve on their own. Common side effects include pain or redness at the injection site or occasionally a mild fever. Serious side effects are rare.

One study found that only a small number of people experience moderate to severe fever after receiving the flu vaccine. Specifically, 1.1% of those who received a high-dose flu shot reported this type of fever, compared to 0.3% of those who received a standard dose. Overall, the benefits of flu vaccination outweigh the risks, and the vaccine undergoes careful monitoring to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how COVID-19 affects immunity to the flu vaccine. Unlike typical flu vaccine studies that focus only on healthy individuals, this trial includes participants who have had COVID-19, providing insights into any potential differences in vaccine response. Understanding these differences could lead to improved vaccination strategies for people recovering from COVID-19, ultimately enhancing public health outcomes during flu season.

What evidence suggests that the flu shot is effective for immunity in patients who have had COVID-19?

Research has shown that flu vaccines are usually effective in preventing the flu. Studies indicate that getting a flu shot can lower the chance of contracting the flu by 40% to 60% during seasons when the vaccine matches the flu viruses well. Additionally, some research suggests that a flu vaccine might also reduce the risk of catching COVID-19 and needing hospitalization, offering an extra benefit for those who have had COVID-19. Overall, the flu shot is known to be safe and effective in lowering the risk of flu-related illness.

In this trial, participants will be divided into two groups: one group will receive the flu shot, while the other will serve as a control. This design will help evaluate the potential benefits of the flu shot in the context of COVID-19. ^{6 7 8 9 10}

Who Is on the Research Team?

Sayantani Sindher, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

Adults enrolled in study 55689 (NCT04373148)

Adults diagnosed with severe or moderate COVID-19 at least 2 months prior enrollment

Adults without COVID-19 diagnosis for healthy controls

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive the flu vaccine to measure immunity over time

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immunity response to the flu vaccine

6 months

Periodic visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Flu shot

How Is the Trial Designed?

Group I: Control participants Experimental Treatment 1 Intervention

Group II: COVID-19 participants Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMsa2514268

Updated Evidence for Covid-19, RSV, and Influenza ... We reported outcomes for four domains: epidemiology, vaccine efficacy or effectiveness, safety, and coadministration. Epidemiologic data were ...

2. cdc.gov cdc.gov/flu-vaccines-work/php/effectiveness-studies/index.html

CDC Seasonal Flu Vaccine Effectiveness Studies CDC conducts studies each flu season to help determine how well flu vaccines are working. These vaccine effectiveness (VE) studies help regularly assess the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25010722

Rationalizing recommendations for influenza and COVID ... Here, we compare the effectiveness and safety of COVID-19 and influenza vaccines, as well as their effects on disease course and transmission, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920881/

The Association Between Previous Influenza Vaccination and ... This meta-analysis showed that influenza vaccination was associated with reduced risk of COVID-19 infection (RR=0.83, 95% CI=0.76, 0.90) and hospitalization.

5. gavi.org gavi.org/vaccineswork/dual-covid-19flu-shot-more-effective-individual-vaccines

Study suggest dual COVID-19/flu shot is more effective ... A previous Phase 1/2 study in 1,206 adults found that the vaccine was well-tolerated, had a good safety profile, and triggered immune responses ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/flu.html

Influenza (Flu) Vaccine Safety Many people who get an annual flu vaccine report no side effects at all. Most side effects reported after flu vaccination are mild and disappear ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5861790/

Influenza vaccines: Evaluation of the safety profile - PMC Most influenza vaccines are safe in adults and children. However, they can sometimes cause AEs. According to the age-group, AEs may include fever, vomiting, ...

8. cdc.gov cdc.gov/flu/professionals/acip/app/safety.htm

Safety of Influenza Vaccines Only 1.1% of Fluzone High-Dose recipients reported moderate to severe fever, but this was significantly higher than the 0.3% of Fluzone recipients who reported ...

9. dph.sc.gov dph.sc.gov/diseases-conditions/infectious-diseases/flu/flu-vaccine-safety

Flu Vaccine Safety Are Flu Vaccines Safe? · The benefits of immunization outweigh the risks. · All vaccines are held to the highest standard of safety and are continually monitored.

10. vaccineknowledge.ox.ac.uk vaccineknowledge.ox.ac.uk/flu-vaccine

Flu vaccine Flu vaccines have a very good safety record. The most reported side effects of flu vaccines are: pain, swelling, bruising, hardness, or redness ...