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Study on Antibody Responses in Healthy Individuals After Intranasal and Intramuscular Influenza Vaccination with Fluenz Tetra and Vaxigrip Tetra

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the body responds to different types of flu vaccines. The study involves two types of influenza vaccines: Fluenz Tetra, which is a nasal spray, and Vaxigrip Tetra, which is given as an injection. Both vaccines are designed to protect against the flu, a common viral infection that affects the respiratory system.

The purpose of the study is to compare the immune response, specifically the production of antibodies, between the two methods of vaccination. Antibodies are proteins made by the immune system to help fight infections. The study will look at how these antibodies develop in the nose and blood after receiving either the nasal spray or the injection. Participants will receive one of the vaccines and will have samples taken from their nose and blood at various times to measure the levels and types of antibodies produced.

The study will take place over several weeks, with participants being monitored at different intervals to track changes in their immune response. This includes measuring specific proteins and cells in the body that are involved in fighting infections. The goal is to better understand how each vaccine works and to gather information that could help improve flu vaccination strategies in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination
Upon joining the study, you will receive your first dose of the influenza vaccine. This will be administered either as a nasal spray or as an injection into your muscle. The nasal spray is called Fluenz Tetra, and the injection is called Vaxigrip Tetra.
Step 2
First follow-up
Between 1 and 10 days after your vaccination, you will have a follow-up appointment. During this time, samples will be collected from your nose and blood to measure the levels of specific antibodies. These antibodies help your body fight the flu virus.
Step 3
Second follow-up
On day 14 after your vaccination, another follow-up will occur. Additional samples will be collected to continue monitoring your antibody levels and other immune responses.
Step 4
Third follow-up
On day 21, you will have another follow-up appointment. This is a key point in the study where the main measurement of antibody levels in your nasal fluid will be taken. This helps to compare the effectiveness of the nasal spray versus the injection.
Step 5
Final follow-up
The last follow-up will be on day 70 after your vaccination. This appointment will involve collecting final samples to assess the long-term effects of the vaccine on your immune system.

Who can join the trial?

3 criteria

Participants must be between 18 and 40 years old.
Both male and female participants are eligible.
Participants should be generally healthy without significant other health issues. This means they should not have any major illnesses or conditions, especially no problems with their immune system, which is the body's defense against infections.

Who cannot join the trial?

4 criteria

Participants must be healthy individuals. This means you should not have any ongoing illnesses or medical conditions.
Participants must be within a specific age range, which is typically defined by the study. Please ensure you meet the age requirements.
Both male and female participants are eligible, so gender is not a restriction.
Participants should not belong to a vulnerable population. This generally refers to groups who may have additional risks or require special protection, such as pregnant women, children, or those with certain disabilities.

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

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Investigated drugs

Influenza Vaccine The influenza vaccine is designed to protect against the flu, a contagious respiratory illness caused by influenza viruses. In this study, the vaccine is being administered in two different ways: intranasally, which means it is sprayed into the nose, and intramuscularly, which means it is injected into a muscle. The goal is to see how the body's immune system responds to the vaccine when given through these different methods. The study will look at both the amount and the quality of antibodies, which are proteins made by the immune system to fight off the flu virus.

What is already known about the treatment

Influenza Vaccine – The influenza vaccine can be administered either through a nasal spray (intranasal) or a shot (intramuscular). This vaccine is currently well-established in medical practice and literature as a preventive measure against the flu. It is primarily used to protect healthy individuals from influenza infection. The vaccine works by stimulating the body's immune system to produce antibodies that recognize and fight the flu virus. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.

Investigated diseases

Influenza – Influenza, commonly known as the flu, is a contagious respiratory illness caused by influenza viruses. It primarily affects the nose, throat, and sometimes the lungs. The disease typically begins suddenly and can cause symptoms such as fever, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, and fatigue. Influenza can spread through droplets when an infected person coughs, sneezes, or talks. The virus can also be transmitted by touching surfaces or objects that have the virus on them and then touching the mouth, nose, or eyes. The progression of the disease can vary, with symptoms lasting from a few days to less than two weeks.