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

Verified siteRegistered drugNo placebo

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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 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.

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 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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 trial?

3 criteria

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.

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Verified sites

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Université Libre de Bruxelles - Hôpital Erasme
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Brussels, Belgium

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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.

Raxtozinameran

What is already known about the treatment

SARS-CoV-2 Immunity Monitoring – This study involves monitoring the immunity levels against the SARS-CoV-2 virus in both healthy individuals and those with weakened immune systems, such as nursing home residents, dialysis patients, and organ transplant recipients, aged 18 to 105. The study is not focused on a specific medication but rather on assessing the presence of antibodies that can bind to and neutralize the virus. The main goal is to understand how well these antibodies work against the most common variant of the virus, with assessments conducted three times a year. This research is part of a larger effort to understand COVID-19 immunity, especially in vulnerable populations.

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.