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RecruitingTherapeutic use (Phase IV)Interventional

Antibody Glycosylation dynamics After Vaccination (AGAVE)

Every year, millions of people get vaccinated against the flu to stay healthy. This study compares two well-known flu vaccines: an injection in the arm (Vaxigrip Tetra) and a gentle nasal spray (Fluenz Tetra). Both vaccines are already approved and routinely used in the UK and Europe. Researchers want to understand how our bodies build defence shields, particularly inside the nose where the flu virus first enters. By taking small samples of nasal fluid, saliva, and blood over about 10 weeks, scientists can measure protective proteins called antibodies. They want to see which vaccine provides stronger local protection in the airways. If you are a healthy adult aged 18 or older, taking part could help doctors design better, more effective vaccines in the future. The trial lasts around 70 days and involves several clinic visits to track your body's immune response.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Leids Universitair Medisch Centrum (LUMC)
Enrolment target
60
Start
26 May 2025

What is this study about?

Flu is a common viral infection that can make people feel very unwell, especially during the winter. Getting an annual flu vaccine helps train your immune system to fight off the virus before it causes illness. While both flu jabs and nasal sprays are widely used, scientists are still learning about how each type activates the body's defences in different areas, such as the nose and the blood.

This clinical trial, called the AGAVE study, compares the standard flu jab with the flu nasal spray in healthy adults. Because flu viruses enter through the nose and throat, having strong immune barriers right inside the nose could stop an infection before it starts. Researchers are measuring special proteins called antibodies, which act like natural security guards against viruses, to see how their levels and shapes change after vaccination.

Both vaccines used in this study are already approved and widely trusted. By studying blood, saliva, and nasal fluid samples, the research team hopes to learn which method builds the strongest local shield. The findings could help improve how future vaccines are made and delivered, offering better protection against flu and similar winter bugs.

Key takeaways

  • Compares the immune response of a standard flu jab against a flu nasal spray.
  • Focuses on how protective antibodies develop inside the nose and bloodstream.
  • Open to healthy adults aged 18 and older.
  • Involves clinic appointments and sample collections over a 10-week period.
  • Uses approved vaccines that are already part of routine healthcare.

Who may be eligible?

This trial is open to healthy adults aged 18 and over. Both men and women are welcome to take part. Because the study looks at how a typical immune system responds to flu vaccines, volunteers should generally be in good health without major long-term illnesses.

You may not be eligible if you have an ongoing condition that affects your immune system, or if you take medicines that weaken your body's ability to fight infections. The researchers will also check if you have already had a flu vaccine this season or have recently had the flu.

A member of the research team will talk through your medical history with you to ensure that joining the study is safe and right for you.

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.

  1. I am aged 18 or older.
  2. I am in good general health.
  3. I have not yet had a flu vaccine for the current flu season.
  4. I am comfortable giving blood, saliva, and gentle nasal samples.
  5. I am able to attend clinic visits over roughly 10 weeks.
Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for about 70 days (10 weeks). You will be randomly chosen to receive either the standard flu injection in your arm or the flu nasal spray. You will need to attend several clinic visits, mostly during the first three weeks, with a final check-up on day 70. During these visits, the research team will collect small blood samples, saliva, and gentle swabs or fluid samples from inside your nose. These tests allow scientists to watch how your body builds protection over time.

Potential risks and benefits

You may not get any direct personal benefit from taking part, though you will receive a seasonal flu vaccine that can protect you against flu. Both vaccines are well-tested, but you might experience mild, short-lived side effects. These can include a sore arm from the injection, a runny nose from the spray, a mild headache, or feeling tired for a day or two. Giving blood and nasal samples may cause brief discomfort. Taking part is entirely voluntary, and you are free to leave the study at any time without it affecting your standard NHS care.

Locations (1)

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

Common questions

What is the main goal of the AGAVE study?

The study aims to see whether a flu nasal spray creates more protective antibodies inside the nose compared to a traditional flu jab in the arm.

Are the vaccines used in this study safe?

Yes. Both the nasal spray and the injection are standard, approved flu vaccines that have already been given safely to millions of people.

Can I choose which vaccine I receive?

No. Participants are placed into one of the two vaccine groups by chance so that the study results remain fair and unbiased.

Does collecting nasal fluid hurt?

The procedure is gentle and quick. It may feel a bit tickly or strange for a few seconds, but it should not be painful.

Will taking part cost me any money?

No. All study vaccines and tests are provided free of charge, and trial teams often help cover reasonable travel costs.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Antibody Glycosylation dynamics After Vaccination (AGAVE)…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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