AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Phase 1 (sequential)/2a (parallel), double-blind, multicenter, randomized, controlled study to evaluate the safety and immunogenicity of two administrations of OVX033 sarbecovirus candidate vaccine, given intramuscularly (IM) at one-month interval, at three dose levels, in comparison to placebo, in subjects aged 18 years and older

This research is a Phase 1 and 2a clinical trial looking into a new vaccine, OVX033, designed to protect against sarbecoviruses, a type of virus family that includes the one causing COVID-19. It will involve adults aged 18 and older. Participants will be given two doses of the vaccine or a placebo (a dummy injection) over a month. The main goals are to understand how safe the vaccine is by looking for side effects, and to see if it makes the body's immune system ready to fight off these viruses. This study is an important step in developing new ways to prevent sarbecovirus diseases.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Osivax

Enrolment target

240

Start

24 Jan 2025

Sarbecoviruses disease

What is this study about?

This study is exploring a new vaccine called OVX033. This vaccine is designed to target a group of viruses known as sarbecoviruses, which includes the virus that causes COVID-19. Researchers want to find out how safe this new vaccine is and how well it helps your body's immune system respond to these viruses. By understanding these two key things, they can decide if it's promising enough to continue testing in larger groups of people.

The study is split into two parts: Phase 1 and Phase 2a. In Phase 1, a smaller number of people will receive the vaccine at different dose levels. This helps researchers work out which doses are safest and if there are any immediate side effects. In Phase 2a, more people will be involved, and the focus will still be on safety, but also on getting a clearer idea of how the immune system reacts to the vaccine at different strengths. Some participants will receive the actual vaccine, while others will receive a placebo, which looks just like the real vaccine but contains no active ingredients. This helps researchers compare the effects accurately.

The findings from this study are very important. If the vaccine proves to be safe and shows that it can kick-start the immune system effectively against sarbecoviruses, it could eventually lead to new vaccines that help protect people from diseases caused by these viruses, including future pandemics like COVID-19.

Key takeaways

This study is testing a new vaccine (OVX033) for sarbecoviruses, including COVID-19.
It's an early-stage study focusing on vaccine safety and how the immune system reacts.
Participants aged 18 and older will receive two doses of the vaccine or a placebo.
You won't know if you get the vaccine or the placebo (a dummy injection).
Close monitoring for side effects and immune responses will occur over several months.
Your participation helps advance research into preventing future viral diseases.

Who may be eligible?

To join this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

However, there will be other health conditions or medications that might mean you cannot join. These details will be checked by the study doctors to make sure it's safe for you to participate and that the study results will be accurate. It's important that you discuss your full health history with the study team.

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 18 years old or older?
Are you able to attend appointments over several months?
Are you comfortable with receiving injections?
Are you willing to have blood samples taken?
Are you willing to report any health changes or symptoms you experience?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive two injections into your muscle, one month apart. Some participants will get the actual vaccine, and others will get a placebo (a dummy injection). You won't know which one you've received, nor will the study team, to keep the results fair.

After each injection, you'll be asked to record any side effects you notice for a week. The study team will also closely monitor you for any health changes or symptoms for up to a month after each injection and throughout the entire study. They'll also check your immune response by taking blood samples at specific times, such as before the first injection and then at roughly 8, 36, and 57 days after the first injection. These blood tests help to see how well your body is reacting to the vaccine. The total duration of your participation in the study will be some months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to the development of a new vaccine that could protect against sarbecoviruses. You would be helping to advance medical science. However, it's important to remember that you might receive the placebo, which means you wouldn't get any direct protection from the vaccine during the study. Potential risks could include side effects from the injections, such as pain or redness at the injection site, or more general symptoms like fever or headaches, similar to other vaccines. There might also be other unexpected side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What are sarbecoviruses?

Sarbecoviruses are a group of viruses that includes the one that causes COVID-19. This vaccine aims to protect against diseases caused by these types of viruses.

What does 'Phase 1 and 2a' mean for a trial?

These are early stages of testing. Phase 1 looks at safety in a small group, and Phase 2a expands that to more people to check safety and how well the immune system responds, at different doses.

Will I know if I get the vaccine or the placebo?

No, neither you nor the study team will know if you received the vaccine or the placebo. This is a common practice in studies to ensure the results are unbiased and reliable.

What kind of side effects will they be looking for?

They will look for common side effects like pain or swelling where you had the injection, and more general symptoms like feeling tired or having a headache. They will also monitor for any other unexpected health issues.

How often will I need to visit the clinic?

You will need to attend for two main injection appointments, one month apart. There will also be a number of follow-up visits and possibly blood tests at specific times over several months.