A Phase IV, open label, single arm trial to assess the safety and immunogenicity of BIMERVAX® LP.8.1 against SARS-CoV-2 variants.
This research is a Phase IV trial looking at a new COVID-19 vaccine called BIMERVAX LP.8.1. We want to understand how safe this vaccine is and how well it helps your immune system create protective antibodies against SARS-CoV-2, including the Omicron variant and others. In simpler terms, we're checking for any side effects and how strong your body's defence against the virus becomes after getting this vaccine. This kind of study helps us confirm the vaccine's safety and effectiveness in a wider group of people after it has already gone through earlier testing phases. The results will give us more information about how well this vaccine works against current and future COVID-19 strains.
At a glance
What is this study about?
This study is about a new COVID-19 vaccine called BIMERVAX LP.8.1. You might wonder what a 'Phase IV' trial means. Well, vaccines go through different stages of testing. Phase I, II, and III trials happen before a vaccine is widely used to make sure it's safe and effective. A Phase IV study, like this one, takes place after a vaccine has been approved and is being used by people. It allows us to gather even more information about its safety and how well it works in a larger number of people over a longer time, especially against new versions of the virus.
The main goal of this particular study is to carefully look at two things. Firstly, we want to understand any side effects people might have after getting the BIMERVAX LP.8.1 vaccine. This includes common, mild reactions like a sore arm, as well as any unexpected or more serious issues. Secondly, we're checking how well the vaccine helps your body produce protective antibodies. These antibodies are like tiny soldiers that fight off the SARS-CoV-2 virus, which causes COVID-19. We're especially interested in how well these antibodies work against new versions of the virus, like the Omicron variant.
By gathering all this information, researchers can make sure the vaccine continues to be safe and effective for everyone, even as the virus changes. This helps doctors and health authorities make the best decisions about how to protect public health. The study uses special tests to measure the number of antibodies in your blood before and after vaccination to see how your immune system responds.
Key takeaways
- This study is testing a new COVID-19 vaccine (BIMERVAX LP.8.1) in people who have already been vaccinated.
- It aims to check for side effects and how well the vaccine helps your body fight different COVID-19 strains, especially Omicron.
- Participation involves receiving the vaccine, reporting how you feel for a week, and having blood tests.
- The study helps gather more safety and effectiveness information after a vaccine is in general use.
- You can withdraw from the study at any point.
- The study is open to both men and women, of all adult ages.
Who may be eligible?
This study is generally open to adults who have already received previous COVID-19 vaccinations. Because it's a Phase IV trial, it's designed to gather more information in people who are already part of the vaccinated population.
There are no specific age limits mentioned, meaning adults of all ages, from younger adults to older adults, could potentially take part. Both men and women are welcome to participate in this research.
Specific detailed criteria, such as your general health, any existing medical conditions, or medications you might be taking, will be discussed by the study team to ensure this study is suitable and safe for you. It's important that you meet all the study requirements to ensure the safety and accuracy of the research.
- Are you an adult aged 18 or over?
- Have you already received previous COVID-19 vaccinations?
- Are you willing to receive one dose of the study vaccine?
- Are you able to attend study visits and have blood tests?
- Are you able to record and report any side effects you experience?
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 receive one dose of the BIMERVAX LP.8.1 vaccine. The study team will then closely monitor you for 7 days after your vaccination to record any immediate reactions or side effects. This involves you keeping track of how you feel and reporting it to the study team. You will have regular contact with the study team to discuss any side effects you might experience, both expected and unexpected, throughout the study period.
You will also have blood tests at key points in the study, specifically before you get the vaccine (this is called 'Baseline') and again 14 days after your vaccination. These blood tests help us measure the levels of antibodies your body produces in response to the vaccine. The total duration of your participation in the study will continue until the study concludes, during which time any significant medical events will be noted. There will be specific visits for assessments and blood draws, and the research team will explain the schedule to you in detail.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is a 'Phase IV' trial?
A Phase IV trial happens after a vaccine is approved and in general use. It helps researchers gather more information about its safety and how well it works in a larger number of people over time.
What is BIMERVAX LP.8.1?
BIMERVAX LP.8.1 is the COVID-19 vaccine being studied. It's designed to help your body fight off the SARS-CoV-2 virus and its variants, like Omicron.
What kind of side effects are you looking for?
We're looking for all kinds of side effects, from common ones like a sore arm or feeling tired, to any unexpected or more serious reactions. You'll be asked to report how you feel.
Will I have to give blood samples?
Yes, you will have blood tests before getting the vaccine and again 14 days later. These are to check your body's immune response.
Can I leave the study if I change my mind?
Absolutely. You are free to withdraw from the study at any time without having to give a reason, and it won't affect your medical care.
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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