Study on the Immune Response to Bretovameran COVID-19 mRNA Vaccine in Healthy Adults Aged 18-40

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What is this study about?

This clinical trial is focused on studying the effects of a vaccine for COVID-19, a disease caused by the coronavirus. The vaccine being tested is called Comirnaty JN.1, which is a type of mRNA vaccine. This vaccine is designed to help the body recognize and fight the virus that causes COVID-19. The study will involve healthy adults aged 18 to 40 years who have previously received a COVID-19 vaccine at least three months before participating in this trial.

The purpose of the study is to evaluate how the body’s natural defense system, known as the innate immune response, reacts shortly after receiving the Comirnaty JN.1 vaccine. Participants will receive the vaccine through an injection into the muscle. The study will observe the body’s response at different times: before the vaccine is given, and then 6 hours and 24 hours after the injection. Researchers will look at certain markers in the blood that indicate how the immune system is responding.

Throughout the study, researchers will also monitor for any serious side effects that might be related to the vaccine. The study aims to provide more information on how the vaccine affects the immune system in the short term, which can help in understanding its overall effectiveness and safety. The study is expected to conclude by February 2025.

1 joining the study

Upon joining the study, you will be confirmed as eligible based on your age, medical stability, and previous vaccination status. You must be between 18 and 40 years old, medically stable, and have received a SARS-CoV-2 vaccine at least 3 months prior to this study.

2 receiving the vaccine

You will receive an injection of the Comirnaty JN.1 COVID-19 mRNA vaccine. This is administered as an intramuscular injection, which means it is given directly into a muscle.

3 monitoring after vaccination

Your body’s response to the vaccine will be monitored. Blood samples will be taken before the injection, 6 hours after, and 24 hours after the injection. These samples will help measure levels of certain substances in your blood that indicate how your immune system is responding.

The study will look at specific markers in your blood, such as interferon gamma and interleukin-1 alpha and beta, which are indicators of inflammation and immune response.

4 ongoing observation

Throughout the study, any serious adverse events (SAEs) related to the vaccine will be recorded. This means any significant health issues that occur after receiving the vaccine will be documented and assessed by the study team.

5 completion of the study

The study is expected to conclude by February 28, 2025. Your participation will help evaluate the short-term immune response to the vaccine in healthy adults.

Who Can Join the Study?

Must be a male or female aged 18 to 40 years at the time of receiving the study vaccine.
Must be considered medically stable by the study doctor. This means your health condition is steady and not likely to change suddenly. If you have a long-term health condition like high blood pressure or heart disease, you can still join if the study doctor thinks it won’t affect your immune response.
Must have received a SARS-CoV-2 vaccine at least 3 months before getting the study vaccine.

Who Cannot Join the Study?

People who are currently sick with COVID-19 cannot participate.
Individuals who have had a severe allergic reaction to any ingredient in the vaccine are not eligible.
Pregnant or breastfeeding women are not allowed to join the study.
Anyone with a weakened immune system, which means the body’s defense against infections is not strong, cannot take part.
Participants who have received another COVID-19 vaccine within the last 30 days are excluded.
People with a history of blood clotting disorders, which means problems with how blood clots, are not eligible.
Individuals who are currently participating in another clinical trial cannot join this study.
Anyone with a history of severe heart problems, such as a heart attack, is not allowed to participate.
People with uncontrolled chronic diseases, which are long-lasting health conditions, are excluded.
Individuals who have had a recent surgery or plan to have surgery during the study period cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Uwulwghocs Om Aryjwra	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.01.2025

Trial locations

Comirnaty JN.1® is a COVID-19 mRNA vaccine used in this clinical trial. It is designed to help your body develop an immune response against the virus that causes COVID-19. The vaccine works by using a small piece of the virus’s genetic material, called mRNA, to instruct your cells to produce a harmless part of the virus. This part is known as the spike protein, which is found on the surface of the virus. Once your body makes this protein, your immune system recognizes it as foreign and starts building an immune response. This helps your body to be prepared to fight the actual virus if you are exposed to it in the future. The trial aims to study how well this vaccine can trigger the body’s natural defenses, both through antibodies and other immune cells, in healthy adults aged 18 to 40 years.

Investigated diseases:

COVID-19

COVID-19 – COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. It primarily spreads through respiratory droplets when an infected person coughs, sneezes, or talks. The disease can start with mild symptoms such as fever, cough, and fatigue, but it may progress to more severe respiratory issues like difficulty breathing. In some cases, it can lead to complications affecting other organs, including the heart and kidneys. The progression of symptoms can vary widely among individuals, with some experiencing mild symptoms and others developing severe illness. The disease can also cause long-term effects, known as “long COVID,” where symptoms persist for weeks or months after the initial infection.

Trial ID:

2024-520304-26-00

Protocol code:

INNATE-GAP-CLIN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Immune Response to Bretovameran COVID-19 mRNA Vaccine in Healthy Adults Aged 18-40

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?