RecruitingNAINTERVENTIONAL

Understanding the Determinants of Mucosal Immunity and Optimizing the Diagnosis of Infection With SARS-CoV-2 Variants

This study is looking into how our bodies create a defence against COVID-19, particularly in areas like our nose and throat, which are the first places the virus enters. We want to understand how different types of immunity (our body's protection system) work against the virus and its changing forms, like the Delta and Omicron variants. This includes studying what's called 'mucosal immunity,' which acts as a barrier at the entry points of the virus. We also hope to develop more accurate and user-friendly tests for COVID-19. By understanding these things better, we can improve current treatments and develop new ways to protect people from the virus and reduce the impact of the pandemic.

At a glance

Status

Recruiting

Phase

Sponsor

Institut Pasteur

Enrolment target

Start

15 Dec 2023

Estimated completion

18 Jun 2026

COVID-19

What is this study about?

This research wants to understand how our bodies fight off COVID-19, especially focusing on the parts that are first exposed to the virus, like the inside of your nose and mouth. This is important because new versions of the virus keep appearing, and they are often better at spreading and escaping our existing protection from vaccines or past infections. By carefully studying how our immune system, particularly this 'mucosal immunity,' works, we hope to find better ways to prevent and treat the illness.

The study also aims to improve how we test for COVID-19. Imagine a test that's not only very accurate but also easy to use and helps us understand more about the infection, like how much virus is present and how it changes over time. By collecting samples like blood and saliva, along with nose swabs and breath samples, we can learn a lot about how the body reacts to the virus and use this knowledge to create these improved tests. These better tests could help healthcare professionals make quicker, more reliable decisions.

Ultimately, the goal is to make a real difference in how we handle COVID-19. By gaining a deeper understanding of our body's defences and developing advanced testing methods, we can help reduce the spread of the virus and make sure people get the best possible care. This research is a step towards building stronger protection for everyone against current and future versions of the virus.

Key takeaways

This study aims to understand how our bodies protect against COVID-19, especially in the nose and mouth.
It also seeks to develop better and more reliable tests for the virus.
Participation involves providing various samples like blood, saliva, and nose swabs over several visits.
The study focuses on adults aged 18-65, either with or without recent COVID-19 infection.
Your contribution could lead to improved strategies for managing COVID-19 for everyone.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 65 years old and live in the Paris region of France (Ile-de-France) so you can attend appointments in Paris. You also need to be well enough to give blood samples and have French social security.

If you have COVID-19, you must have tested positive with a PCR test within the last 72 hours, have mild or no symptoms, and not need to be in hospital. If you don't have COVID-19, you must have tested negative with a PCR test and have no more than three ongoing health problems that aren't severe.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, have another serious infection, have been positive for COVID-19 in the last month, or have had symptoms for more than four days if you're ill with COVID-19. If you do not have COVID-19, you cannot have had an infection or vaccine within the last three months.

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 between 18 and 65 years old?
Do you live in the Paris, France (Ile-de-France) region?
Are you able to travel to Paris for study visits?
If you have COVID-19, did you test positive by PCR within the last 3 days?
If you do not have COVID-19, have you avoided prior infection or vaccination in the last 3 months?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you take part and have COVID-19, you will visit the clinic four times. The first visit is soon after your positive test, then again about a week later, then a month after that, and finally three months after your first visit. If you don't have COVID-19, you'll have two visits: an initial visit and then another one about three months later. During each visit, you'll provide several types of samples: blood, saliva, a swab from your nose and the back of your throat, and a breath sample collected by breathing into a special device. Each blood collection will be about 55ml, which is just over an ounce, and you can give a maximum of 111ml over 28 days. The total duration of your involvement in the study will be about three months.

Potential risks and benefits

Participating in research studies like this helps us learn more about diseases and develop better ways to diagnose and treat them, which could benefit many people in the future. There are no direct benefits to you personally, but your contribution is valuable. The main risks are minor discomfort or bruising from blood tests and other sample collections. You are free to change your mind and stop participating at any time during the study without it affecting your medical care.

Locations (1)

Institut Pasteur - ICAReB-clin
Verified postcode
Paris, France· Recruiting

Common questions

What is 'mucosal immunity'?

Mucosal immunity is your body's protection system in moist areas like your nose, mouth, and throat, which are often the first places germs enter. It's like the first line of defence.

Why are you looking at different types of immunity?

Different types of immunity protect us in different ways. We're trying to understand which parts of our immune system are most effective against the ever-changing COVID-19 virus.

What kind of samples will be collected?

We will ask for blood, saliva, a swab from your nose and throat, and a breath sample collected by breathing into a device.

Will I get results from my samples?

No, you will not receive individual results from the samples you provide. The samples are used for research purposes to understand the bigger picture.

Is this study testing a new drug or vaccine?

No, this study is not testing a new drug or vaccine. It's focused on understanding how our bodies fight the virus and improving diagnostic tests for COVID-19.

How to find out more

Hélène Laude, MD

helene.laude@pasteur.fr 33145688394 Official trial record

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