RecruitingPhase IInterventional

A clinical trial to assess whether a self-amplifying ribonucleic acid (saRNA) vaccine against Rabies viruses is safe and induces immune responses

This is a study for a new rabies vaccine called RAB-Vac, being tested in people for the very first time. We want to find out if it's safe to use and how your body's defence system (immune system) responds to it. This particular study will not check if the vaccine actually prevents rabies. We're looking for healthy volunteers aged 18-50. If you take part, you'll receive the vaccine by injection and we'll monitor you closely for any side effects. You'll also need to provide blood samples and keep a diary of your symptoms. The study lasts about a year and aims to gather important information for developing future rabies vaccines.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Imperial College London

Enrolment target

Start

31 May 2026

Estimated completion

31 Aug 2026

Rabies

What is this study about?

Rabies is a very serious disease, and researchers are always looking for better ways to prevent it. This study is testing a new type of vaccine called RAB-Vac. It's an 'RNA' vaccine, which uses a clever way to teach your body to fight off the rabies virus. This particular RNA vaccine is a `self-amplifying` type, meaning it should create more of the vaccine within your cells, potentially leading to a stronger immune response.

Because this is the very first time this new vaccine will be given to people, the main goal of this study is to check if it's safe. We also want to understand how your immune system responds to it, which means looking at how your body builds up its defences. It's important to know that this study won't tell us if the vaccine actually prevents you from getting rabies; that would be for future studies. For now, we're focusing on safety and immune responses in healthy adults.

The information gathered from studies like this is crucial. It helps scientists understand how new vaccines work and whether they are safe enough to move on to larger studies that test how well they protect against diseases. Your participation could help in the development of a safe and effective rabies vaccine that could eventually be available to many people around the world.

Key takeaways

Tests a new rabies vaccine (RAB-Vac) for safety and immune response.
First time vaccine is given to humans.
Looking for healthy volunteers aged 18-50 years.
Involves injections, blood samples, and symptom diaries over one year.
No direct health benefits for participants, but aids future vaccine development.
Potential side effects are generally mild and temporary.

Who may be eligible?

This study is looking for healthy adults between 18 and 50 years old. You need to be willing to give your informed consent, meaning you understand the study and agree to take part. This will involve signing a form.

If you are a woman who could become pregnant, you must be willing to use a very effective method of contraception (birth control) for a set period during and after the study injections. If you are a man, you must agree not to get a female partner pregnant during the study period and use condoms. Certain types of birth control, like the rhythm method, aren't considered effective enough for this study. You will also need to avoid other vaccines for a few weeks before and after the study injections.

Finally, you need to be able to attend all planned appointments, complete online diaries about your health, and give blood samples. You also can't donate blood for at least three months after the study ends and must agree for the study team to look at your medical and GP records related to the trial.

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 a healthy adult between 18 and 50 years old?
Are you willing to use effective birth control if you could become pregnant, or use condoms if you are a man?
Can you attend all study appointments over about one year?
Are you willing to provide blood samples and keep an online diary?
Can you avoid other vaccines for a few weeks around study injections?
Are you prepared not to donate blood for at least 3 months after the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of six different groups. You will receive either a low, medium, or high dose of the vaccine. The vaccine will be given as a needle injection into your muscle. You'll have three injections in total, either at weeks 0, 4, and 24, or at weeks 0, 12, and 24, depending on your group.

Throughout the study, we'll monitor you closely for any reactions to the vaccine. You'll be asked to keep an online diary to record any symptoms you experience. To see how your immune system is reacting and how long that response lasts, you'll need to give blood samples at various times. The total duration of your involvement in the study will be about one year from your first injection.

Potential risks and benefits

There's no direct health benefit for you personally from taking part in this study. However, your participation is incredibly valuable as it helps us gather vital information for developing a potentially new, safe, and effective rabies vaccine. We've tried to make sure the study has as few burdens and risks as possible. You might find attending all appointments an inconvenience, and there are specific rules about contraception and blood donation. Blood samples can sometimes cause minor bruising or soreness. You might experience common, mild-to-moderate side effects like pain or redness at the injection site, tiredness, or headache, similar to other vaccines. Very rarely, more serious reactions like severe allergic reactions or heart inflammation (myocarditis/pericarditis) have been linked to similar vaccines, but these are extremely uncommon. You are always free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Chelsea and Westminster Hospital Clinical Research Facility (CRF) at St Stephen’s Centre
Unverified
London, England

Common questions

What is `RNA` in a vaccine?

RNA is like a set of instructions that teaches your body's cells to make a small, harmless part of the rabies virus. Your immune system then learns to recognise and fight off the real virus.

Will this vaccine protect me from rabies?

This particular study does not test if the vaccine protects against rabies. It's solely focused on checking the vaccine's safety and how your immune system responds to it.

What are the most common side effects I might experience?

You might feel some temporary pain, redness, or swelling where you got the injection. Other common effects can include tiredness, general aches, or a headache.

Can I still donate blood after the study?

No, you must agree not to donate blood for at least three months after your last study visit, or potentially longer if the study team advises.

Who is running this study?

This study is being run from Imperial College London in the UK, with funding from the Coalition for Epidemic Preparedness Innovations.

How to find out more

Marta Boffito

marta.boffito@nhs.net +44 (0)208 3156148 Official trial record

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