Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2a, single center, randomized, double-blind, study to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels (180µg or 480μg) given intramuscularly (IM), either as a booster or a primary vaccination in healthy adults previously administered with OVX836, Influvac Tetra® or placebo in the OVX836-002 (EudraCT number: 2019-002939-28) and OVX836-003 (EudraCT number: 2021-002535-39) studies

This study is looking into a new flu vaccine called OVX836. We're testing it in healthy adults to understand how safe it is and how well it helps your body create protection against the flu at two different dose amounts (180µg or 480μg). Participants will receive one dose of the vaccine, given as a simple injection into the muscle. We are especially interested in people who have previously had an OVX836 vaccine or a common flu jab called Influvac Tetra®. This will help us learn if OVX836 could be a good booster or a first-time vaccine for different people. We will be carefully checking for any side effects and how your immune system responds.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

OSIVAX Belgique

Enrolment target

117

Start

04 Oct 2024

Influenza

What is this study about?

This research study is about a new flu vaccine called OVX836. We're looking to understand more about its safety and how effectively it prepares your body to fight off the flu virus. We're testing two different dose levels of the vaccine to see if one works better or has fewer side effects. This is a "Phase 2a" study, which means it’s an early step in testing new medicines or vaccines, focusing on safety and how the body reacts.

Participants in this study will receive a single injection of the OVX836 vaccine into a muscle. We are particularly interested in two groups of people: those who have previously taken part in studies involving OVX836, and those who have had a common flu vaccine called Influvac Tetra®. This helps us see how OVX836 works as a booster dose or as a first vaccine in people who might already have some protection against flu.

Throughout the study, we will be carefully monitoring participants for any side effects, both expected and unexpected, to ensure the vaccine is safe. We will also be taking blood samples to see how well the vaccine helps your immune system create protective cells and antibodies against the flu. This information is really important for developing better flu vaccines in the future.

Key takeaways

Tests a new flu vaccine (OVX836) in healthy adults.
Checks vaccine safety and how well it boosts your immune system.
Participants receive one injection of OVX836.
Open to adults aged 18+ who have had specific previous flu vaccines.
Aims to improve future flu protection.

Who may be eligible?

This study is open to healthy adults aged 18 and over. There’s no upper age limit, meaning older adults can also take part if they are otherwise healthy.

You must have taken part in a previous study testing the OVX836 vaccine, or have received the standard Influvac Tetra® flu vaccine in the past. This is because we want to see how this new vaccine works as either a booster or a first-time vaccine in people who might have some previous exposure to flu vaccines.

Before you can join, the study team will ask you some health questions and do some checks to make sure the study is a good fit for you and that taking part would be safe.

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 generally in good health?
Have you previously received the OVX836 vaccine in another study?
Alternatively, have you previously received the Influvac Tetra® flu vaccine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive one injection of the OVX836 vaccine into your arm. For seven days after the injection, we will ask you to keep track of any local symptoms (like soreness at the injection site) or general symptoms (like feeling tired or having a headache). We’ll also check in with you for any other side effects for about a month (29 days) after your vaccine.

Throughout the study, we'll keep an eye out for any serious health problems that might occur. We will also regularly take blood samples to measure how your immune system is responding to the vaccine, looking at specific cells and antibodies that fight off flu. The study team will explain exactly how many visits you will need and the full duration of your involvement.

Potential risks and benefits

Taking part in this study may offer the potential benefit of contributing to the development of a new flu vaccine, which could help protect many people in the future. As with any vaccine, there are potential risks, such as local soreness or redness at the injection site, or feeling a bit unwell for a short time. Serious side effects are rare but possible, and the study team will monitor you closely. 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.

—
Unverified
Belgium

Common questions

What is the OVX836 vaccine?

OVX836 is a new flu vaccine that researchers are testing to see how well it works and if it's safe.

Who can join this study?

Healthy adults aged 18 or older who have previously had an OVX836 vaccine or a standard flu jab (Influvac Tetra®) can be considered.

What will I need to do if I join?

You will receive one vaccine injection. You'll also need to monitor for side effects and have blood tests to check your body's response to the vaccine.

Is this vaccine already available to the public?

No, OVX836 is still in the testing phase (Phase 2a) and is not yet available for general use.

What kind of side effects might I experience?

Common side effects might include soreness at the injection site or feeling generally unwell, similar to a regular flu jab. Serious side effects are rare.