A first-in-human phase 1, single center, randomized, double-blind, placebo-controlled study to evaluate the safety and immunogenicity of three dose levels of the OVX033 vaccine, after intramuscular administration in healthy subjects aged 18-49 years
This study is looking at a new vaccine called OVX033. It's designed to protect against diseases caused by 'sarbecoviruses' – a group of viruses that includes the one behind COVID-19. This is an early stage of testing, meaning it's the very first time this vaccine is being given to people. Healthy volunteers aged 18 to 49 will receive the vaccine. The main goals are to check if it's safe and if it helps their immune system learn to fight off these viruses. This study will also try different dose levels of the vaccine to see which one works best and is safest. Participants might get the actual vaccine or a dummy shot (placebo), and neither they nor their doctors will know which one they received.
At a glance
What is this study about?
You might have heard about coronaviruses, like the one that causes COVID-19. 'Sarbecoviruses' are a bigger group of viruses that includes those types. Researchers are working on new ways to protect us from them. This study is about testing a brand new vaccine, called OVX033, that they hope will help protect people from diseases caused by sarbecoviruses.
This is a very early stage of testing, often called a 'Phase 1' study. It's special because it's the first time this vaccine will ever be given to people. This means it's super important to carefully watch how people react to it. The main things the doctors want to find out are if the vaccine is safe and if it helps the body's natural defences (the immune system) get ready to fight off these viruses if they encounter them in the future.
Everyone taking part is a healthy adult between 18 and 49 years old. They will receive different amounts (doses) of the vaccine, or a dummy shot (placebo), to help find the best and safest dose. By taking part, volunteers are helping scientists learn crucial information that could lead to new vaccines that protect many people in the future.
Key takeaways
- This study is testing a new vaccine (OVX033) for sarbecoviruses, like the COVID-19 virus.
- It's the first time this vaccine is being given to people.
- The main goals are to check its safety and how it affects the immune system.
- Healthy adults aged 18-49 can participate.
- Participants will receive either the vaccine or a dummy shot, given as an injection.
- Taking part helps advance scientific knowledge for future vaccines.
Who may be eligible?
This study is looking for healthy adults. To join, you must be between 18 and 49 years old. Both men and women can take part.
Because this is an early study to check safety, there will be other health requirements. For example, you likely won't be able to join if you have certain ongoing health problems or are taking specific medications. The study team will check your full medical history to make sure taking part is safe for you.
It’s important to remember that joining a clinical study is a big decision, and it’s crucial that the study is right and safe for you. The study team will explain everything carefully and answer all your questions during the screening process.
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 49 years old?
- Are you generally healthy?
- Are you willing to attend regular clinic visits?
- Are you comfortable with blood tests and injections?
What does participation involve?
If you decide to take part, you'll first have a screening visit to check your health and make sure you're suitable for the study. If you qualify, you'll then be randomly assigned to receive one of three different doses of the OVX033 vaccine, or a dummy shot (placebo). Neither you nor your study doctor will know which one you receive.
The vaccine (or placebo) will be given as a shot into your muscle, typically in your arm. You'll have several visits to the clinic over a period of time. During these visits, doctors and nurses will closely monitor your health, ask about any side effects you might be feeling, and take blood samples. These blood samples help them understand how your immune system is responding to the vaccine.
You'll also likely need to keep a diary or record at home, noting down any changes in how you feel. The study will involve a follow-up period to make sure you remain well and to collect all necessary information. The total duration of your participation will be explained by the study team, but typically, early-stage vaccine studies like this can last for several months to over a year.
Potential risks and benefits
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Common questions
What is a 'sarbecovirus'?
It's a type of virus family that includes the one that causes COVID-19. Scientists are looking for ways to protect against them.
What does 'first-in-human' mean?
It means this is the very first time this new vaccine is being given to people. It's an important early step to check its safety.
Will I know if I get the actual vaccine or a dummy shot?
No, neither you nor your study doctor will know. This helps make the study results fair and accurate.
Do I have to pay to join the study?
No, you should not have to pay to take part in the study. Any study-related medical care or medication will be provided.
What happens if I change my mind?
You can leave the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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