Temporal kinetics of antibody and cellular response markers and relative impact of revaccination in patients recovered from COVID-19 after treatment with monoclonal antibodies
This study is for people who have recovered from COVID-19 and were treated with certain antibody medicines called monoclonal antibodies. Researchers want to understand how their immune system, specifically the antibodies and special immune cells, responds to COVID-19 vaccines over time. They are looking at two booster vaccination timings: either 4 months or 12 months after receiving the antibody treatment. The goal is to see if one timing leads to a better or longer-lasting immune response. The study will measure different types of antibodies and immune cell activity at various points over a year to learn the best way to protect these individuals down the line. It uses several well-known COVID-19 vaccines.
At a glance
What is this study about?
This study is investigating something important for people who have recovered from COVID-19 and received special treatments called monoclonal antibodies. These antibody treatments help fight off the virus. Now, researchers want to see how well different COVID-19 vaccines work in these individuals, especially after they've had the antibody treatment. They're focusing on how the immune system responds and how long that protection might last.
The main aim is to understand the timing of a booster vaccine. Participants will either get a booster vaccine 4 months or 12 months after their antibody treatment. The researchers will then check for two main things: "humoral response markers" (which means checking the levels of different antibodies in the blood) and "cellular response markers" (which looks at how immune cells react to the virus).
They'll take blood samples at several points over a year to measure these immune responses. This will help them figure out if getting a booster earlier or later makes a bigger difference in strengthening and prolonging the protection against COVID-19. The study uses common COVID-19 vaccines you might already know, such as Comirnaty, Spikevax, and Nuvaxovid, along with some antibody treatments like Evusheld and Xevudy that were given previously.
Key takeaways
- Checks how COVID-19 vaccines work after antibody treatment.
- Compares booster vaccine timing: 4 months versus 12 months.
- Measures different types of antibodies and immune cell activity.
- Aims to find the best way to protect people who've had COVID-19 and antibody therapies.
- Involves blood tests over about a year.
- Uses adult participants aged 18 and over.
Who may be eligible?
This study is open to adults aged 18 and older. Both men and women can take part.
To be eligible, you must have previously had COVID-19 and have been treated with specific antibody medicines called monoclonal antibodies.
More detailed eligibility criteria would be discussed with you by the research team to make sure it's the right study for you, but generally, it's for adults who fit this description.
- Are you 18 years old or older?
- Have you recovered from COVID-19?
- Were you treated with monoclonal antibodies for your COVID-19?
- Are you able to attend regular clinic visits and have blood tests for about a year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be carefully monitored over a period of time. The study involves receiving a COVID-19 booster vaccine, either 4 months or 12 months after you had your monoclonal antibody treatment for COVID-19. This means there will be specific appointments to receive the vaccine.
Throughout the study, you will have several visits to the clinic. At these visits, blood samples will be taken. These samples will be used to measure your antibody levels and the activity of your immune cells at different times: at the start of the study, and then at 1, 4, 6, 9, and 12 months after you received your monoclonal antibody treatment. Some specific tests for cell immunity will be done at 0, 4, and 12 months. The full duration of your participation would involve these regular check-ups and blood tests over approximately one year.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What are 'monoclonal antibodies'?
These are special medicines that give your body extra antibodies to help fight off a virus, like COVID-19.
What kind of vaccines are being used?
The study uses well-known COVID-19 mRNA vaccines (like Pfizer and Moderna) and a recombinant vaccine (like Novavax).
Why are they checking at 4 months versus 12 months?
Researchers want to see if getting a booster vaccine earlier (at 4 months) or later (at 12 months) gives you better or longer-lasting protection.
What does 'immune response' mean?
This refers to how your body protects itself from illness, specifically by making antibodies and using special immune cells.
Do I have to get a vaccine if I join?
Yes, a core part of this study involves receiving a COVID-19 booster vaccine at a specific time.
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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