Study on COVID-19 Immunity in Immunocompromised Adults Using Raxtozinameran and Bretovameran in Belgium

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What is this study about?

This clinical trial is focused on understanding the immune response to SARS-CoV-2, the virus responsible for COVID-19, in people with weakened immune systems. The study involves healthy individuals and those who are immunocompromised, such as nursing home residents, dialysis patients, and kidney and lung transplant patients, aged 18 to 105. The trial will use two different vaccines: Comirnaty Omicron XBB.1.5 and Comirnaty JN.1, both of which are mRNA vaccines designed to protect against specific variants of the virus.

The purpose of the study is to assess the level of antibodies, which are proteins in the blood that help fight infections, against the most common variant of the virus. This will be done three times a year. The study will also look at how well the vaccines work in creating a strong immune response, which includes both the quality of the antibody response and the cellular immune response, which involves other parts of the immune system that help protect against infections.

Participants in the study will receive the vaccines through an injection. The study will take place over several years, from 2023 to 2026, to gather comprehensive data on how the immune system responds over time. This information will help improve understanding of vaccine effectiveness in people with different health conditions and contribute to better protection strategies against COVID-19.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on previous participation in specific cohorts such as PICOV-VAC, REDUVAC, Lung-VAC, or Nephro-VAC.

A detailed explanation of the study’s purpose and procedures is provided. Consent is obtained to participate in the study.

2 vaccine administration

Participants receive the Comirnaty Omicron XBB.1.5 or Comirnaty JN.1 COVID-19 mRNA vaccine. Each dose contains 30 micrograms and is administered as an injection.

The vaccine is given according to the study schedule, which is designed to assess the immune response over time.

3 antibody assessment

Three times a year, blood samples are collected to measure the level of binding and neutralizing antibodies against the predominant SARS-CoV-2 variant.

These assessments help determine the effectiveness of the vaccine in generating an immune response.

4 detailed immune response study

In addition to antibody levels, the study examines the quality of the antibody response and measures the cellular immune response.

This involves further analysis of blood samples to understand how the immune system responds to the vaccine.

5 follow-up visits

Regular follow-up visits are scheduled throughout the study period, which runs until December 31, 2026.

These visits are essential for monitoring health status and collecting necessary data for the study.

Who Can Join the Study?

  • Participants must be healthy individuals or immunocompromised patients. Immunocompromised patients include those living in nursing homes, undergoing dialysis, or who have had kidney or lung transplants.
  • Participants must be between the ages of 18 and 105.
  • Participants must have previously taken part in one of the following studies: PICOV-VAC, REDUVAC, Lung-VAC, or Nephro-VAC.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Individuals who are not between the ages of 18 and 105.
  • Individuals who are not healthy or are not immunocompromised. Immunocompromised means having a weakened immune system, which can make it harder to fight off infections.
  • Individuals who are not residents of nursing homes, or are not dialysis patients, or are not kidney or lung transplant patients. Dialysis is a treatment that does some of the things done by healthy kidneys, and a transplant is when an organ is moved from one body to another.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Mensura EDPB – Gosselies Gosselies Belgium
Sciensano Ixelles Belgium
Mensura EDPB – Hasselt Hasselt Belgium
Mensura EDPB – Betlehem Herent Belgium
Mensura EDPB – Damiaan Tremelo Belgium
Mensura EDPB – Brussel Brussels Belgium
Mensura EDPB – Residentie ter Kameren Watermael-Boitsfort Belgium
Mensura EDPB – Antwerpen Antwerp Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Mesmppc Evql &tfintp Skst Azph Haaltert Belgium
Mftpktq Emqe &btihsy Zabovtba Aartselaar Belgium
Mnkmscu &bcrrvn Zbmefzlghh Zwijnaarde Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
02.01.2023

Trial locations

Investigated drugs:

The provided data does not include specific medications or therapies involved in the clinical trial. Therefore, I am unable to list or describe any medications or therapies based on the given information. If you have additional data or details about the medications or therapies used in the trial, please provide them so I can assist you further.

Investigated diseases:

COVID-19 – COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. It primarily affects the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can progress from mild symptoms to severe respiratory distress, especially in individuals with weakened immune systems. In some cases, it can cause complications like pneumonia and acute respiratory distress syndrome. The virus spreads mainly through respiratory droplets from coughs or sneezes. The progression and severity of the disease can vary widely among individuals.

Trial ID:
2024-518098-33-01
NCT ID:
NCT05667597
Trial Phase:
Therapeutic confirmatory (Phase III)

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