Active not recruitingEARLY_PHASE1INTERVENTIONAL

Vaccine Pandemic Preparedness Through Airway Immunology Characterization

Researchers are conducting a study to understand how two types of flu vaccines – a nasal spray and a jab – work in healthy adults aged 18 to 49. The main goal is to find out which vaccine creates a stronger immune response, helping our bodies fight off the flu more effectively. By looking at how our immune system reacts, the study hopes to discover key indicators that can help make future flu vaccines better and faster to develop, especially for new pandemics. This research is also setting up a way for scientists to work together more easily on vaccine research.

At a glance

Status

Active not recruiting

Phase

EARLY_PHASE1

Sponsor

Copenhagen Respiratory Research

Enrolment target

Start

19 May 2025

Estimated completion

27 Jul 2026

Influenza, Human

What is this study about?

This research study is looking into how two different types of flu vaccines work in healthy people aged between 18 and 49 years old. One type is a nasal spray flu vaccine, often called a 'live attenuated influenza vaccine' (LAIV). The other is a flu jab, known as an 'intramuscular-inactivated vaccine' (IIV). The main idea behind the study is to see if one type of vaccine makes our immune system stronger and better able to fight off the flu.

After the recent coronavirus pandemic, there's a lot of focus on how important vaccines are for our health. This study wants to find out if the nasal spray vaccine creates a more powerful response from our immune cells compared to the flu jab. Scientists will be looking closely at how our body's defence system reacts to each vaccine. The aim is to find specific signals or 'markers' in the immune system that can help design even better vaccines in the future. This could lead to more effective protection against the flu and faster development of new vaccines when needed.

The study is designed to be very thorough and fair. It's a 'randomised, double-blind, placebo-controlled' study. This means that participants are randomly assigned to a group, and neither they nor the researchers will know who is getting which vaccine or a dummy treatment (placebo) until the study is over. This helps ensure the results are as unbiased as possible. The study is also carefully monitored to follow good medical research practices.

Key takeaways

Compares nasal spray and jab flu vaccines.
Aimed at healthy adults aged 18-49.
Hopes to find better ways to fight flu.
Could help develop new vaccines faster.
Is a carefully designed, fair, and monitored study.

Who may be eligible?

To join this study, you need to be a healthy adult aged between 18 and 49 years old. Doctors will check your overall health and look at certain levels in your blood to make sure you fit the criteria. For example, they'll check that your immune system is working typically and that you haven't recently been vaccinated against the flu.

There are also some reasons why you wouldn't be able to join. For instance, if you've had a confirmed flu infection in the last year, are a smoker, have a very high BMI (body mass index over 35), or are pregnant or breastfeeding. Also, if you have certain medical conditions like HIV, Hepatitis B or C, certain cancers, or serious mental health issues that might make it hard to take part, you wouldn't be eligible.

You also can't take part if you're taking medicines that weaken your immune system, or if you've had other vaccines recently (within the last 4 weeks) or plan to have any within a month of joining the study. You must also not be allergic to any ingredients in the flu vaccines being tested.

Quick self-check

Are you between 18 and 49 years old?
Are you generally healthy with no serious existing medical conditions?
Have you not had a confirmed flu infection in the last year?
Are you not a smoker?
Are you not pregnant, breastfeeding, or planning to become pregnant during the study without using safe contraception?
Are you not taking medicines that suppress your immune system?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first have a screening visit to check if you're eligible. If you are, you'll then receive either a nasal spray flu vaccine (Flumist), a flu jab (Vaxigripetra), or a dummy treatment (placebo). You won't know which one you've received, and neither will the study team, to keep the results fair.

Throughout the study, you'll have several visits to the clinic where doctors and nurses will take blood samples and check on your health. These visits will help the researchers understand how your immune system is responding to the vaccine or placebo. The study will involve a series of check-ups and observations over a period, and the total duration from your first visit to your last follow-up is not specified but usually lasts several months to a year for early-phase vaccine studies.

Potential risks and benefits

Participating in this study might offer personal benefits, such as receiving a flu vaccination that you might not otherwise get, and contributing valuable information to help develop better flu vaccines for everyone. You might experience some common side effects from the vaccines, such as a sore arm from the jab, a runny nose from the spray, or mild flu-like symptoms. More serious side effects are rare but possible. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Denmark
Diagnostic Immunology, Department of Clinical Immunology, Rigshospitalet, Denmark
Copenhagen, Denmark
Institute for Immunology and Microbiology (ISIM), Panum Institute, University of Copenhagen
Copenhagen, Denmark
Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital
Gentofte Municipality, Denmark
National Influenza Center for WHO at Statens Serum Institut (SSI)
Copenhagen, Denmark
Technical University of Denmark (DTU)
Kongens Lyngby, Denmark
Imperial College
London, United Kingdom

Common questions

What is the main goal of this study?

The main goal is to compare how two different types of flu vaccines (nasal spray and jab) work to protect against the flu and to find ways to make future vaccines even better.

Who can take part in this study?

Healthy adults aged 18 to 49 who meet specific health requirements can take part.

Will I know which treatment I receive?

No, neither you nor the study team will know if you received a specific vaccine or a placebo until after the study is complete, to ensure fair results.

What kind of visits will I have?

You'll have screening visits, a vaccination visit, and several follow-up visits for blood tests and health checks.

Can I leave the study if I change my mind?

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