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AuthorisedTherapeutic use (Phase IV)Interventional

LONGITUDINAL FOLLOW-UP OF SARS-COV-2 IMMUNITY IN IMMUNOCOMPROMISED POPULATIONS IN BELGIUM (COVICO) A non-commercial multicenter academic prospective cohort study during 2023-2026

This study, called COVICO, is happening in Belgium from 2023 to 2026. It's designed to understand how strong COVID-19 immunity is in different people, including those who are healthy and those with weakened immune systems. This includes nursing home residents, dialysis patients, and people who have had kidney or lung transplants. Participants, aged 18 to 105, will receive updated COVID-19 vaccines. Researchers will check their antibody levels three times a year to see how well these vaccines protect against new versions of the virus. The goal is to learn more about vaccine protection and improve how we keep everyone safe, especially those more vulnerable to serious illness.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Sciensano
Enrolment target
360
Start
25 Nov 2024

What is this study about?

This study, called COVICO, is a really important research project happening in Belgium. Its main goal is to understand how well COVID-19 vaccines protect people, especially those whose immune systems might not work as strongly as others. This includes people living in nursing homes, those on dialysis, and individuals who have received kidney or lung transplants, as well as healthy people for comparison. The study will run from 2023 to 2026.

Participants in the study will receive the latest COVID-19 vaccines, which are designed to protect against newer versions of the virus. The researchers will then regularly check their blood for special fighters called 'antibodies.' These antibodies are what your body makes to help fight off infections. By checking these levels three times a year, the scientists can see how strong and long-lasting the protection is against the most common types of COVID-19 at that time.

Why is this important? Understanding how well vaccines work in different groups helps doctors and public health experts make better decisions about how to protect everyone, especially those who are more vulnerable to severe COVID-19. This study will give us a clearer picture of how our immune systems respond to the vaccines and the virus, helping us improve vaccination strategies in the future.

Key takeaways

  • Study examines COVID-19 vaccine protection in healthy and vulnerable groups.
  • Focuses on people with weakened immune systems, such as transplant patients or those on dialysis.
  • Participants will receive updated COVID-19 vaccines and have regular blood tests.
  • Aims to understand antibody levels and immune response over time.
  • Findings will help improve future vaccination strategies.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, so people up to 105 years old can take part.

They need healthy people to understand the typical immune response. They also particularly want people with weakened immune systems. This includes those who live in nursing homes, patients who receive dialysis treatment for kidney problems, and people who have had a kidney or lung transplant.

Both men and women can join this study if they meet the age and health requirements.

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. Are you 18 years old or older?
  2. Do you live in Belgium?
  3. Are you a healthy individual?
  4. Do you have a weakened immune system due to conditions like dialysis, a kidney or lung transplant, or living in a nursing home?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be one of the participants being observed from 2023 to 2026. This means you wouldn't be given a new, experimental drug, but rather existing COVID-19 vaccines (like Comirnaty Omicron XBB.1.5 or Comirnaty JN.1) that are already in use. The main part of your involvement would be having your blood checked three times a year. These blood tests will help the researchers measure your antibody levels to see how your body is responding to the vaccine and fighting off the virus. There won't be any special medication to take or other interventions beyond receiving the standard COVID-19 vaccines. The total duration of your participation would be from when you join until the study concludes in 2026.

Potential risks and benefits

Taking part in this study could help us learn more about how COVID-19 vaccines protect different people, which can lead to better health recommendations for everyone. You might also benefit from receiving updated COVID-19 vaccines as part of the study. As with any medical procedure, there are some small risks, such as mild discomfort or bruising from blood draws, and potential side effects from the vaccine (like a sore arm or feeling tired) which are usually temporary. You are always free to change your mind and withdraw from the study at any time without giving a reason, and it won't affect your medical care.

Locations (1)

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

Common questions

What is the main purpose of this study?

The study aims to understand how well COVID-19 vaccines protect people, especially those with weaker immune systems, by checking their antibody levels regularly.

Who can join this study?

Adults aged 18 or older can join. This includes healthy people and those with weakened immune systems, like nursing home residents, dialysis patients, and transplant patients.

What will I have to do if I join?

You will receive updated COVID-19 vaccines and have blood samples taken three times a year to check your antibody levels. No experimental drugs are involved.

Will I get a new medicine?

No, you will receive standard, updated COVID-19 vaccines that are already approved for use, not experimental medicines.

How long does the study last?

The study runs from 2023 to 2026, so your participation would last until the study concludes within that timeframe.

How to find out more

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

Discussion

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