Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

First-in-human Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of the Adjuvanted Universal Influenza Vaccine “fH1/DSP-0546LP” in Healthy Adults

This study is an early-stage trial looking at a new type of flu vaccine, called fH1/DSP-0546LP. It's often called a 'universal flu vaccine' because it aims to protect against many different kinds of flu, rather than just a few types each year. Researchers are giving this new vaccine to healthy adults for the very first time. The main goals are to check if it's safe to use, make sure people can tolerate it well without too many side effects, and see if it helps their bodies create a strong immune response against the flu virus. This is an important step in developing new ways to protect us from influenza.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Sumitomo Pharma Co. Ltd.

Enrolment target

144

Start

03 May 2024

Influenza

What is this study about?

You've probably heard about the flu vaccine you get every year. This study is about a new and different kind of flu vaccine, often called a 'universal flu vaccine'. The idea behind a universal flu vaccine is to offer protection against many strains of the flu virus, which could mean you wouldn't need a new shot every single year.

The specific vaccine being tested here is called fH1/DSP-0546LP. This trial is the very first time it will be given to people, which is why it's called a 'Phase 1' study. At this early stage, the most important thing is to make sure the vaccine is safe for people to use and that their bodies don't react badly to it. Doctors and scientists will be watching very closely for any side effects.

They also want to see if the vaccine helps your body build up a defence, or 'immune response', against the flu virus. This is like teaching your body to recognise and fight off the virus if you encounter it later. If this early study shows promising results for safety and immune response, it could pave the way for bigger studies to see how well it actually protects people from getting the flu.

Key takeaways

This is a first-time test of a new 'universal flu vaccine' in humans.
The main goals are to check how safe it is and if people tolerate it well.
Researchers also want to see if it helps your body build protection against flu.
Participants must be healthy adults, 18 years old or over.
Your involvement could help develop future flu protection for everyone.

Who may be eligible?

This study is looking for healthy adults who are 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially take part. Both men and women are welcome to participate in this research.

Because this is the very first time this vaccine is being tested in humans, it's really important that participants are generally in good health. This helps the researchers understand the vaccine's effects without other health conditions making things complicated.

As with all clinical trials, there will be specific health checks and questions to ensure it's safe for you to join. For example, if you have certain ongoing health problems or take particular medications, you might not be able to participate. The study team will discuss all of these details with you if you're interested.

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 healthy?
Are you able to attend all required study visits?
Are you willing to provide blood samples?
Do you understand this is a new, untested vaccine?

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 make sure you're suitable for the study. This would involve health checks, tests, and answering questions about your medical history. If you qualify, you would receive the study vaccine. You would then need to attend several follow-up visits over a period of time. During these visits, the study team would check for any side effects, ask how you're feeling, and take blood samples. These blood samples help them understand how your body is reacting to the vaccine and building immunity. The total duration of your participation, including all visits and follow-ups, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in a trial like this might not directly benefit you, as the main goal is to understand the new vaccine's safety and how it works. However, you would be helping medical science explore new ways to protect against flu. Potential risks include common vaccine side effects like soreness, redness, or swelling where you got the shot, or feeling tired, headache, or mild fever. There could also be unexpected side effects, as this is a new vaccine. 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 a 'universal flu vaccine'?

It's a new type of flu shot designed to protect against many different kinds of flu viruses, possibly meaning you wouldn't need a new one every year.

Why is this called a 'Phase 1' study?

Phase 1 means it's the very first time this new vaccine is being given to people. The main goals are to check its safety and how well people tolerate it.

Will I get the actual flu if I join?

No, you will not be exposed to the flu virus. The vaccine contains parts of the virus or instructions for your body to make parts of the virus, not the live virus itself.

What does 'immunogenicity' mean?

It means how well the vaccine helps your body create protection (an immune response) against the flu virus.

Do I need to be healthy to join?

Yes, this study is looking for healthy adults because it's the first time the vaccine is being tested in people, so it's important to have a clear picture of its effects.