RecruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

This study is looking at a new flu vaccine made from plants. This vaccine is designed to protect against three common types of flu. We want to see if it's safe for people to use, how well their bodies react to it (this is called immunogenicity), and to work out the best amount (dose) to give. The study involves two groups of adults: those aged 18 to 64, and those aged 65 and over. This is a crucial early step to make sure the vaccine is suitable for further testing and could eventually become available to the public to help protect against flu.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Aramis Biotechnologies Inc.

Enrolment target

728

Start

25 Feb 2026

Estimated completion

01 Dec 2026

Influenza

What is this study about?

This research study is about a new type of flu vaccine. Flu, or influenza, is a common illness that can make you feel very unwell, and for some people, it can be serious. Each year, scientists work to create new vaccines to help protect us from the latest flu strains.

This particular vaccine is quite innovative because it's 'plant-based' and uses something called a 'Virus-Like Particle' (VLP). VLPs are like empty shells of the virus; they look like the virus to your body but can't actually make you sick. This allows your immune system to learn how to fight the real virus without you ever getting the flu. The vaccine is also 'trivalent,' meaning it's designed to protect against three specific types of flu that are expected to be common during a flu season.

The main goal of this study is to check if this new vaccine is safe for people to use and if it helps their bodies build up a good defence against the flu. We're also trying to find the best dose to give people. This is an early-stage study (called Phase 1/2), which means it's one of the first times it's being tested in a larger group of people after initial safety checks. If it proves safe and effective, it could become a new option to help protect against the flu in the future.

Key takeaways

It's a study testing a new, plant-based flu vaccine.
The vaccine aims to protect against three flu types.
It's an early-stage study to check safety and find the best dose.
Open to adults aged 18 and over.
Participation involves visits, blood tests, and health checks.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and in generally good health. You should be able to understand what's involved and be willing to attend study appointments regularly. Your body mass index (BMI) should be 39 or below, and you shouldn't be living in institutional care like a nursing home. We'll also check your medical history, do a physical exam, and some blood and urine tests to make sure you're suitable.

There are also reasons why you wouldn't be able to join. For example, if you have a serious ongoing medical condition, an illness that affects your immune system (like cancer or HIV, though some past, cured infections might be okay), or if you are pregnant or breastfeeding. Also, if you plan to become pregnant during the study, you wouldn't be able to participate. The study doctor will make the final decision based on a thorough review of your health.

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?
Are you able to attend all study appointments?
Are you not pregnant or breastfeeding?
Do you not have a serious ongoing medical condition that affects your immune system?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to check if you meet all the requirements. If you do, you would receive the study vaccine. You would then have several follow-up visits and phone calls over a period of time to monitor your health, check for any reactions, and see how your body is responding to the vaccine. This might involve blood tests, physical examinations, and answering questions about how you're feeling. The exact number of visits and their timing would be fully explained before you agree to join. The total duration of your participation would be for a specific period, which will be outlined in the consent form.

Potential risks and benefits

Participating in a study like this helps advance medical science and could lead to new ways to prevent flu. You might also gain access to a new vaccine that isn't yet available. However, there are potential risks, such as side effects from the vaccine, like soreness at the injection site, fever, or other reactions. There's also the chance the vaccine might not offer full protection. All procedures carry some small risks, like discomfort from blood draws. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

Canadian Center for Vaccinology (CCfV) - IWK Health
Verified postcode
Halifax, Canada· Recruiting
Montreal Heart Institute
Verified postcode
Montreal, Canada· Recruiting
Vaccine Study Centre of McGill University Health Centre
Verified postcode
Pierrefonds, Canada· Recruiting
CHU de Québec - Université Laval
Verified postcode
Québec, Canada· Recruiting
Diex Recherche - Sherbrooke
Verified postcode
Sherbrooke, Canada· Recruiting
Diex Recherche - Trois-Rivières
Verified postcode
Trois-Rivières, Canada· Recruiting
Diex Recherche - Victoriaville
Verified postcode
Victoriaville, Canada· Recruiting

Common questions

What is a 'plant-based' vaccine?

It means the vaccine is made using plant materials, rather than traditional methods like using chicken eggs. It's an innovative way to produce vaccines.

What does 'trivalent' mean?

It means the vaccine is designed to protect against three different types or strains of the flu virus, which are usually the most common ones expected in a flu season.

What is a 'Virus-Like Particle' (VLP)?

VLPs are like empty shells from the virus. They look like the real flu virus to your body but can't actually cause an infection. This helps your immune system learn to fight the real virus.

Will I get the flu from this vaccine?

No, because the vaccine uses 'Virus-Like Particles' (VLPs) which are not the actual virus and cannot make you sick with the flu.

How long will I be in the study?

The full duration of your participation will be explained in detail if you are invited to join, including all visits and follow-up periods.

How to find out more

Sonia Trepanier, Ph.D.

strepanier@aramisbiotechnologies.com Canada: 1-418-655-7158 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.