RecruitingNAINTERVENTIONAL

GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE

This research study aims to understand how our bodies protect themselves against the flu after both having a vaccine and getting the actual flu infection. We are looking for healthy adult volunteers aged 18 to 55 to take part. Participants will either be given a flu vaccine through a nasal spray or be safely exposed to a mild flu virus. We will then carefully compare the immune responses in their nose, throat, and lungs. The goal is to learn more about how our immune system works, which could help develop better ways to prevent and treat flu in the future. The study does not make any medical recommendations.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

16 Apr 2025

Estimated completion

31 Jul 2026

Influenza

What is this study about?

This study is designed to help us better understand how our immune system, which is our body's defence against illness, reacts to the flu. We know that flu can be a serious illness, and vaccines are an important way to protect people. But we still have a lot to learn about how our bodies develop protection, especially in the nose, throat, and lungs where the flu virus first enters.

In this research, we're comparing two ways our bodies might get protection: from a special flu vaccine given as a nasal spray, and from actually getting a controlled, mild flu infection. By looking at how healthy adults' immune systems respond to both, we hope to discover important differences and similarities. This knowledge could be really helpful for scientists and doctors who are working to create even better flu vaccines and treatments in the future.

We are looking for healthy volunteers because their immune systems are usually working as they should. This allows us to see how a typical, healthy person's body reacts to the vaccine or the virus without other health conditions making it more complicated. The information we gather will help us make progress in understanding and tackling the flu, ultimately benefiting many people.

Key takeaways

This study helps scientists understand how our bodies fight the flu.
It compares immune responses from a nasal spray vaccine and a mild flu infection.
Healthy adults aged 18-55 are needed as volunteers.
Participants will be closely monitored for safety.
The information learned could lead to improved flu prevention and treatments.

Who may be eligible?

This study is looking for healthy adults between the ages of 18 and 55. To join, you should not have had the flu recently, and your blood tests should show that you don't already have strong protection against the specific flu strain we're studying. If you are a woman who could get pregnant, you must be using effective birth control or unable to get pregnant. Men must also agree to use birth control.

You cannot take part if you have certain existing health conditions. This includes significant heart or breathing problems, diabetes, severe migraines, or conditions that affect your immune system. You also can't participate if you've had certain major illnesses like cancer in the past, or if you have specific nose or throat conditions or have had recent surgery in those areas.

Finally, if you've had a bad reaction to previous vaccines, have allergies to the flu vaccine components, or are currently unwell with a cold or flu, you wouldn't be able to join. The research team will carefully check your health to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Are you generally in good health with no major ongoing medical conditions?
Do you not easily catch the flu or have very strong existing protection against it?
If you are a woman, are you using reliable birth control or unable to get pregnant?
Do you not have any significant breathing problems or bad reactions to vaccines?

Answer every question to see your result.

What does participation involve?

Details about what taking part involves would be explained in full by the study team. Generally, if you join, you would likely have several visits to a clinic. These visits would involve health checks, blood tests, and possibly samples taken from your nose or throat. You would either receive a nasal spray flu vaccine or be given a small amount of the flu virus under careful medical supervision.

The study would involve close monitoring, especially if you receive the flu virus, to ensure your safety and track your symptoms. You would have regular check-ups to see how your immune system is reacting to the vaccine or virus. There would also be follow-up appointments to make sure you recover well and to collect all the necessary information. The total duration of your involvement in the study, from your first visit to your final check-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in research can have potential benefits, like contributing to medical knowledge that could help future patients. You might also receive careful health monitoring during the study. However, there are potential risks, such as experiencing mild flu-like symptoms if you receive the virus, or minor side effects from the vaccine like a runny nose. The study team will explain all known risks to you before you decide. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

The study aims to compare how the body's immune system reacts to a nasal spray flu vaccine versus actually getting a mild flu infection, to learn more about flu protection.

Who can take part in this study?

Healthy adults aged 18 to 55 who meet specific health criteria can take part.

Will I actually get the flu if I join?

Some participants will be given a weakened, mild flu virus under very careful medical supervision, to safely study the body's response.

What kind of tests will I have?

You will likely have health checks, blood tests, and samples taken from your nose or throat.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without needing to give a reason, and it won't affect your regular medical care.

How to find out more

Polly Fox, MSc

polly.fox@imperial.ac.uk 0208383 3231 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.