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

A randomized first-in-human, Phase 1, single-center, observer-blind, active-controlled 3-arm study to evaluate the safety, tolerability, and immunogenicity of one single administration of TETRALITE, a novel adjuvanted influenza vaccine, in healthy participants aged 18 to 50 years

This study is a first step in testing a new flu vaccine called TETRALITE. We are looking for healthy adults aged 18 to 50 years to take part. The main goal is to check how safe the new vaccine is and if people have any side effects after getting it. We also want to understand how well people tolerate the vaccine. Researchers will compare TETRALITE to an approved flu vaccine to see which one causes a stronger immune response, meaning how well your body learns to fight off the flu virus. This is a small, controlled study where participants will receive one shot, and their health will be monitored for several months.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Litevax B.V.

Enrolment target

Start

03 Aug 2022

Influenza

What is this study about?

This study is focused on a new vaccine designed to protect against influenza, commonly known as the flu. The new vaccine is called TETRALITE. This is an early-stage study, meaning it's one of the first times this vaccine is being given to people. The main purpose is to make sure it's safe and that people can tolerate it well, meaning they don't experience too many unpleasant side effects. We will also be looking at how well the immune system responds to this new vaccine.

Participants in the study will receive either the new TETRALITE vaccine or a standard, approved flu vaccine called Vaxigrip Tetra. We'll be carefully checking for any side effects, both common ones like a sore arm, and any more serious reactions. We'll also take blood samples to see how the body's immune system reacts and builds protection against the flu strains included in the vaccine. This comparison helps us understand how the new vaccine performs against an already established one.

By taking part, you would be helping researchers gather important information about this potential new flu vaccine. This kind of early research is crucial for developing better ways to protect people from the flu in the future. The information gathered here will help decide if TETRALITE should move into larger studies involving more people.

Key takeaways

This is an early-stage study for a new flu vaccine called TETRALITE.
The main goals are to check the vaccine's safety and how well people tolerate it.
Researchers will compare TETRALITE to an existing flu vaccine.
Healthy adults aged 18-50 are needed to participate.
Participation involves one injection and follow-up visits over six months.

Who may be eligible?

To be considered for this study, you need to be a healthy adult aged 18 to 50 years old. Both men and women are welcome to take part.

The health team will conduct a thorough check to make sure you meet all the necessary requirements for the study. This is to ensure your safety and that the study results are accurate.

It's important that you are generally well and don't have any major ongoing health problems that might affect how you react to the vaccine or the study results.

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 between 18 and 50 years old?
Are you generally healthy?
Are you willing to receive one vaccine shot?
Are you able to attend follow-up appointments for about six months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive one single injection of either the new TETRALITE vaccine or a standard flu vaccine. For the first 7 days after your vaccination, we'll ask you to keep track of any common side effects like soreness or a fever. Over the next 28 days, we'll monitor you for any other unexpected side effects.

You'll have several visits to the clinic for check-ups and blood tests. These visits will be on Day 1 (before vaccination), Day 7, Day 28, and a final visit around Day 180 (about six months) after your vaccination. The total duration of your participation in the study will be about six months.

Potential risks and benefits

Participating in research studies like this always has potential benefits and risks. A potential benefit is contributing to medical science and helping to develop new treatments or vaccines that could improve public health. You will also receive careful medical monitoring throughout the study. Potential risks include common vaccine side effects like soreness, redness, or swelling where you got the injection, headache, or feeling tired. There's also a small chance of more serious reactions, though these are carefully monitored. 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
Belgium

Common questions

What is the study testing?

This study is testing a new flu vaccine called TETRALITE to see if it's safe and how well it helps your body fight off the flu.

Who can join the study?

Healthy adults aged 18 to 50 years, both men and women, are invited to participate.

How long will I be in the study?

If you join, your participation will last for about six months from the day you get your vaccine shot.

Will I get the new vaccine or the old one?

You will receive either the new TETRALITE vaccine or a standard, approved flu vaccine. You won't know which one you've received.

What do I need to do if I join?

You'll get one injection, keep track of side effects for a short time, and attend a few follow-up appointments for check-ups and blood tests.