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Study on the Safety and Immune Response of OVX033 Vaccine for Adults with Sarbecovirus Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease caused by , which are a group of viruses that include the virus responsible for COVID-19. The study is testing a new vaccine called , which is given as a solution for injection. The vaccine is being compared to a placebo to see how safe it is and how well it works in helping the body fight off the virus.

The purpose of the study is to evaluate the safety and immune response of the vaccine. Participants will receive two doses of the vaccine, given one month apart, at different dose levels. The study will observe how the body reacts to the vaccine and how it affects the immune system's ability to respond to the virus. The study will include adults aged 18 years and older.

Throughout the study, participants will be monitored for any symptoms or side effects after receiving the vaccine. The study will also measure the immune response by looking at specific cells in the blood that help fight infections. This will help researchers understand how well the vaccine works in protecting against . The study is expected to continue for several years to gather comprehensive data on the vaccine's effectiveness and safety.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
First administration
You will receive the first dose of the OVX033 sarbecovirus candidate vaccine through an intramuscular injection. The dose will be one of three levels: 100 micrograms, 250 micrograms, or 500 micrograms. This will be determined randomly.
After the injection, you will be monitored for any immediate reactions. You will be asked to report any local or systemic symptoms, such as pain at the injection site or fever, for the next 7 days.
Step 2
Monitoring period
For 29 days following the first injection, you will be asked to report any unexpected symptoms or adverse events. This includes any new or unusual symptoms you experience.
You will also be asked to report any symptoms related to COVID-19 or influenza during the entire study duration.
Step 3
Second administration
One month after the first injection, you will receive a second dose of the OVX033 vaccine at the same dose level as the first.
Similar to the first administration, you will be monitored for immediate reactions and asked to report any symptoms for the next 7 days.
Step 4
Follow-up period
For 29 days after the second injection, you will continue to report any unexpected symptoms or adverse events.
You will also be asked to report any symptoms related to COVID-19 or influenza during the entire study duration.
Step 5
Immunogenicity assessment
Your immune response to the vaccine will be assessed at several points: 8 days, 36 days, and 57 days after the first injection. This involves measuring specific immune cells and antibodies in your blood.
A final assessment will occur 5 months after the second injection to evaluate the persistence of your immune response.

Who can join the trial?

9 criteria

Provide written informed consent, which means you agree to participate after understanding the study details.
Be a healthy male or female, as determined by your medical history and a medical examination.
Be aged 18 to 49 years for Phase 1, or 18 years and older for Phase 2a.
Be a beneficiary of a social security scheme, meaning you have access to social health benefits.
Have been vaccinated with a licensed SARS-CoV-2 (COVID-19) vaccine at least twice, with the last dose given at least one month before receiving the study vaccine.
If you are 65 years or older, or 80 years or older, you should follow the current vaccination recommendations, which suggest getting vaccinated each fall, with at least 6 months since your last COVID-19 vaccine or infection (3 months for those 80 and over). The last dose should be at least one month before the study vaccine.
If you are a healthcare professional or medical student, you should follow the latest vaccination recommendations for your profession, with the last dose at least one month before the study vaccine.
Be reliable and willing to participate for the entire study duration and able to follow the study procedures.
Be able to use an eDiary on a tablet, smartphone, laptop, or personal computer to record information during the study.

Who cannot join the trial?

9 criteria

People who are not between the ages of 18 and 49 cannot participate.
Individuals who are not healthy adults cannot participate.
Pregnant or breastfeeding women cannot participate.
People with a history of severe allergic reactions cannot participate.
Individuals with a weakened immune system cannot participate.
People who have received another vaccine within the last 30 days cannot participate.
Individuals currently participating in another clinical trial cannot participate.
People with a history of drug or alcohol abuse cannot participate.
Individuals with any condition that the study doctors believe would make participation unsafe cannot participate.

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Assistance Publique Hopitaux De Paris
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Paris, France

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Investigated drugs

OVX033 sarbecovirus candidate vaccine is a new vaccine being tested to see if it is safe and if it can help the body fight off certain viruses. This vaccine is given as a shot in the muscle, and people in the study receive it twice, with one month between each shot. The study is looking at how the vaccine affects the immune system, particularly how it helps the body create cells that can fight off infections. The goal is to see if this vaccine can help protect people from getting sick from certain viruses, and to make sure it doesn't cause any serious side effects.

Sodium Chloride

What is already known about the treatment

OVX033 – OVX033 is a candidate vaccine administered through an injection into the muscle, known as intramuscular administration. It is currently being studied in clinical trials to assess its safety and ability to trigger an immune response against sarbecoviruses, which are a group of viruses that include the virus causing COVID-19. The vaccine is designed to help the body recognize and fight these viruses by stimulating specific immune cells. It is classified as a vaccine, which is a type of medication that helps prevent infectious diseases.

Investigated diseases

Sarbecoviruses disease – Sarbecoviruses disease is caused by a group of viruses within the coronavirus family, which includes the virus responsible for COVID-19. These viruses primarily affect the respiratory system, leading to symptoms such as fever, cough, and difficulty breathing. The disease can start with mild symptoms that resemble a common cold but can progress to more severe respiratory issues. In some cases, it can lead to pneumonia, which is an infection of the lungs. The progression of the disease varies among individuals, with some experiencing mild symptoms and others developing severe respiratory distress. The disease spreads through respiratory droplets when an infected person coughs or sneezes.