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

A study on the safety of and immune response to different doses of an mRNA vaccine against RSV in healthy adults.

This study is looking into a new type of vaccine designed to protect against Respiratory Syncytial Virus (RSV). RSV is a common germ that can cause cold-like symptoms, but for some, it can lead to more serious chest infections. The main goal of this research is to check how safe this new vaccine is and how well it helps your body build up protection against RSV. Researchers will be testing different amounts (doses) of the vaccine in healthy adults. This is a very early stage of testing, meaning it's one of the first times this experimental vaccine will be given to people. The information gathered will help us understand if it could be a useful way to prevent RSV in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

Start

31 Oct 2024

Respiratory Syncytial Virus Infections

What is this study about?

Imagine getting a bad cold that settles in your chest and makes it hard to breathe sometimes. That’s a bit like what Respiratory Syncytial Virus, or RSV, can do. While many people just get a mild cold, for others – especially babies, older people, and those with certain health conditions – RSV can cause serious problems like bronchitis or pneumonia. There isn't a widely available vaccine for adults yet, which is why studies like this are so important.

This particular study is focusing on a new type of RSV vaccine. It uses a special technology called mRNA, which teaches your body how to recognise the RSV virus and fight it off if you come into contact with it. Think of it like giving your immune system a training manual so it knows what to do if RSV appears.

The main purpose of this research is to understand if this new vaccine is safe for people and if it triggers a good protective response in the body. Researchers will be giving different amounts of the vaccine to healthy adults to see which dose works best and has the fewest side effects. This is a very early step in bringing a new medicine to people, but it’s a crucial one to make sure any future vaccines are both effective and safe.

Key takeaways

This study is testing a new RSV vaccine.
It aims to check the vaccine's safety and how well it helps your body fight the virus.
It's an early-stage study in healthy adults (Phase I).
Different amounts of the vaccine will be tested.
Participation involves regular check-ups and blood tests.
Your involvement helps pave the way for new ways to prevent RSV.

Who may be eligible?

This study is looking for healthy adults to take part. This means you generally feel well and don't have any major, ongoing health problems that might affect how the vaccine works or how your body reacts to it. Men and women are both welcome to join the study.

You need to be at least 18 years old to be considered for this study. There isn't an upper age limit mentioned, but you'll still need to meet the general 'healthy adult' criteria. The research team will ask you some questions about your medical history and might do a basic health check-up to make sure this study is right and safe for you.

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?
Do you consider yourself generally healthy?
Are you free of any major, ongoing health conditions?
Are you able to attend regular appointments at the study site?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the experimental vaccine. You would then need to attend several appointments over a period of time. These visits would involve health check-ups, blood tests to see how your body is responding to the vaccine, and possibly swabs to check for RSV. You will be asked to report any symptoms or side effects you might experience. The research team will explain the exact schedule of visits and what each involves, along with how long the entire study will last for you, typically a number of months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of taking part is contributing to scientific knowledge that could lead to a vaccine preventing a common chest infection. You would also receive close medical attention. Potential risks might include common vaccine side effects like soreness at the injection site, tiredness, or a mild fever, as well as the chance of unexpected side effects from 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.

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Unverified
Spain

Common questions

What is RSV?

RSV is a common virus that can cause cold-like symptoms, but it can sometimes lead to more serious breathing problems, especially in vulnerable people.

What does 'mRNA vaccine' mean?

It's a type of vaccine that teaches your body's cells how to make a harmless piece of the virus, which then trains your immune system to fight off the real virus.

Why are different doses being tested?

Researchers want to find the amount of vaccine that works best to protect against RSV while also having the fewest side effects.

Will I know if I got the real vaccine or a dummy shot?

The study design will explain this. Often, early-stage studies give all participants the experimental vaccine, sometimes different doses, and sometimes a placebo (dummy shot).

How long will I be involved in the study?

The study team will tell you the exact duration, but it typically involves several visits over a period of months to monitor your health and immune response.