A randomized, Phase 1b, single-center, observer-blind, active-controlled study to evaluate the safety, immunogenicity, and immunological mechanisms of one single administration of TETRALITE influenza vaccine at two dose levels of LiteVax Adjuvant, in healthy participants aged 60 years and older and in healthy participants aged 18 to 50 years.
This study is investigating a new flu vaccine called TETRALITE. Researchers want to see if it's safe and how well it helps your immune system learn to fight off the flu virus. They are testing two different amounts of an additive, LiteVax, in the vaccine. The study involves healthy adults, both younger (aged 18-50) and older (aged 60 and above). It's a very early-stage study, meaning it's one of the first times this vaccine is being tested in people. The aim is to understand how your body reacts to the vaccine and how it might protect you from the flu.
At a glance
What is this study about?
This study is about a new flu vaccine being developed, called TETRALITE. You might have heard of flu vaccines before, as they are given every year to help protect people from the flu. This new vaccine is being tested with an additional ingredient called LiteVax, which helps make the vaccine more effective at getting your body to produce protection against the flu.
The main goal of this research is to see if the new TETRALITE vaccine is safe for people. Doctors and scientists will carefully watch participants to make sure there are no unexpected or serious side effects. They also want to understand how well the vaccine helps your body's immune system – its natural defence system – learn to fight off the flu virus. They will be looking at different strengths of the LiteVax ingredient to see which works best.
This is a very early stage of testing for the vaccine in humans, often called a 'Phase 1' study. This means it's one of the first times it's being given to people. The information gathered from this study is really important. It will help researchers decide if the vaccine is promising enough to continue testing in larger studies, eventually aiming to provide better protection against the flu for everyone.
Key takeaways
- Tests a new flu vaccine called TETRALITE.
- Investigates the safety and immune response to the vaccine.
- Includes healthy adults aged 18-50 and 60+.
- Uses an ingredient called LiteVax to boost the vaccine.
- It's an early-stage study to gather important information.
Who may be eligible?
This study is looking for healthy people to take part. This means you should generally be well and not have any serious ongoing health conditions. We don't have all the detailed rules, but typically, participants shouldn't be taking certain medications or have specific medical histories that might affect the study results or your safety.
They are interested in two main age groups: healthy adults between 18 and 50 years old, and healthy adults aged 60 and older. This helps the researchers see how the vaccine works differently in younger and older adults, as immune systems can change with age.
Both men and women are welcome to participate in this study. The medical team will check your full medical history and current health to make sure the study is a good fit for you and that it's safe for you to take part.
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 generally healthy?
- Are you between 18 and 50 years old, or 60 and older?
- Do you have a doctor you can discuss this with?
- Are you able to attend several study visits?
- Are you comfortable with blood tests?
What does participation involve?
If you decide to take part, you would receive one dose of the TETRALITE flu vaccine, which might include LiteVax. The study is planned to be 'observer-blinded', meaning some of the study staff won't know which version of the vaccine you receive, but you might also not know. Before getting the vaccine, you would have a health check-up, perhaps including blood tests and a review of your medical history.
After your vaccination, you would need to attend follow-up visits. These visits would allow the study team to monitor your health, check for any side effects, and take more blood samples. These blood samples are very important as they help the researchers understand how your immune system is responding to the vaccine and if it's building up protection against the flu. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail by the study team.
Potential risks and benefits
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Common questions
What is TETRALITE?
TETRALITE is the name of the new flu vaccine being tested in this study.
What is LiteVax?
LiteVax is an additional ingredient that is added to the vaccine to help your body's immune system respond more strongly to it.
Why are two age groups being studied?
Researchers want to see how the vaccine works in both younger adults (18-50) and older adults (60+) because immune responses can be different depending on age.
Is this vaccine already available to the public?
No, this is an early-stage study, so the vaccine is not yet available to the public. This research helps decide if it can be tested further.
Will I get full protection from the flu if I join?
This study is to learn about the vaccine, not to guarantee protection. You might receive the vaccine, but its full effectiveness against the flu is still being studied.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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