A phase 4, open-label study to evaluate the short-term innate immune response after administration of a COVID-19 mRNA vaccine (Comirnaty JN.1®) in healthy adults aged 18 to 40 years.
This study is looking at how a new COVID-19 vaccine, called Comirnaty JN.1, affects the body's natural defence system in healthy adults aged 18 to 40. We want to understand what happens to your immune system very soon after you get the vaccine. Researchers will take measurements before the vaccine, and then again 6 hours and 24 hours afterwards. They will be checking for changes in certain markers in your blood that show how your immune system is reacting. They also want to see if there are any serious side effects from the vaccine. This is an important step to make sure new vaccines are safe and work as expected.
At a glance
What is this study about?
You might have heard about different phases of clinical trials. This study is a 'Phase 4' trial. This usually means the vaccine has already been approved and is being used, but researchers want to learn more about how it works in larger groups of people or in specific situations. In this case, they are focusing specifically on the Comirnaty JN.1 COVID-19 mRNA vaccine.
The main goal of this study is to understand your body's "innate immune response." Think of your innate immune system as your body's rapid response team, the first line of defence against infections. Researchers want to see how quickly and effectively this part of your immune system reacts to the vaccine by looking at different markers in your blood, like certain proteins that are involved in fighting off illness. They will be taking samples very soon after vaccination – before, and then again just 6 hours and 24 hours later – to get a clear picture of these early changes.
Another important aspect of this study is to keep a close eye on safety. Researchers will be carefully monitoring participants for any serious side effects that might occur after getting the vaccine. This helps ensure that the vaccine continues to be safe for everyone who receives it. By understanding these early immune responses and continuing to monitor safety, scientists can learn more about how COVID-19 vaccines work and continue to improve them.
Key takeaways
- This study helps us understand how the Comirnaty JN.1 COVID-19 vaccine works.
- It focuses on your body's immediate, rapid defence system.
- Researchers will check your immune response very soon after vaccination (6 and 24 hours).
- Safety will be carefully monitored throughout your participation.
- The study is for healthy adults aged 18 and over.
- Your active participation for measurements is completed within 24 hours.
Who may be eligible?
To join this study, you need to be a healthy adult aged 18 or older. There is no upper age limit, meaning if you are over 40, you could still be eligible as long as you meet other health criteria.
Both men and women can take part in this research.
The most important thing is that you are generally healthy. A doctor or nurse involved in the study will check your health to make sure it's safe for you to participate.
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 18 years old or older?
- Are you generally healthy?
- Are you comfortable receiving the Comirnaty JN.1 COVID-19 vaccine?
- Are you able to attend appointments for blood samples before, 6 hours after, and 24 hours after vaccination?
- Do you want to help scientists understand more about vaccine effects?
What does participation involve?
If you decide to take part in this study, you would receive the Comirnaty JN.1 COVID-19 mRNA vaccine. Before getting the vaccine, you would have some samples taken, likely blood samples. You would then receive the vaccine.
After getting the vaccine, you would need to return for two more visits or have samples taken. The first follow-up would be approximately 6 hours after your vaccination, and the second about 24 hours later. At these follow-up visits, more samples would be taken to check how your immune system is reacting. During the entire study, the research team would also be carefully monitoring you for any serious side effects.
The total duration of your active participation in the study would be very short – essentially within a 24-hour period for the main measurements, with ongoing safety monitoring over a slightly longer period as determined by the study doctors.
Potential risks and benefits
Locations (1)
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Common questions
What is a Phase 4 study?
A Phase 4 study happens after a vaccine or medicine has been approved and is being used. It helps researchers learn more about its effects in real-world use and in larger groups of people.
What does 'innate immune response' mean?
This is your body's very first and quickest defence system against infections. This study looks at how this rapid defence reacts to the vaccine.
Will I get the Comirnaty JN.1 vaccine?
Yes, if you join this study, you will receive a dose of the Comirnaty JN.1 COVID-19 mRNA vaccine.
How many times will I need to visit?
You'll have a visit for your vaccination and initial samples, then two follow-up visits, one 6 hours and another 24 hours after. The main part of the study is completed within 24 hours.
What are 'inflammatory biomarkers'?
These are natural substances in your body that increase when your immune system is responding to something, like a vaccine or infection. They help researchers understand your body's reaction.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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