Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized controlled trial to compare the immunogenicity and skin imprinting of intradermal and intramuscular rabies vaccination < RABISKIMM >

This research is looking at different ways to give the rabies vaccine. It's a scientific study (called a clinical trial) to compare giving the vaccine just under the skin (intradermal) versus into the muscle (intramuscular). The main goal is to understand how each method helps your body’s immune system learn to fight rabies. Specifically, we'll be checking special immune cells in the skin and blood to see how well they respond to the vaccine after a booster shot. This study will help us find the most effective way to protect people from rabies, which is a very serious disease.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institute Of Tropical Medicine

Enrolment target

165

Start

31 Jan 2024

Rabies

What is this study about?

This study, called RABISKIMM, is a clinical trial that aims to understand the best way to give the rabies vaccine. Rabies is a very dangerous disease, and vaccination is key to protecting people. Currently, the vaccine can be given in different ways, but we want to find out if one method is more effective at activating your body's immune system.

Researchers will be looking specifically at immune cells, called T cells. These are like little soldiers in your body that remember past infections or vaccinations and are ready to fight if they encounter the virus again. We'll be comparing how many of these T cells are found in the skin and in the blood after a booster vaccine, and how well they respond to the rabies virus. This will be measured using special lab tests.

By comparing the two vaccination methods, skin (intradermal) versus muscle (intramuscular), we hope to learn which approach creates a stronger and longer-lasting protective response in the body. This information is really important because it could help doctors decide the best way to vaccinate people against rabies in the future, making protection even better.

Key takeaways

This study compares two ways of giving the rabies vaccine: into the skin or into the muscle.
The main aim is to find out which method creates a stronger immune response.
Researchers will check special immune cells (T cells) in the skin and blood.
This research could help improve how people are protected from rabies in the future.
You must be an adult aged 18 or over to take part.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of any adult age can take part. Both men and women are welcome to join this research.

Before you can join, the study team will ask you some health questions and do some checks to make sure the study is a safe and suitable option for you. This is standard procedure for all clinical trials to protect your health and ensure the study results are clear.

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 willing to receive a rabies vaccination?
Are you able to attend several clinic visits over a few months?
Are you willing to provide blood and potentially small skin samples?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the rabies vaccine either just under your skin or into your muscle. The study involves several visits to the clinic over a period of time. During these visits, the research team will take blood samples and potentially some very small skin samples to check your immune response. You might also have physical examinations and be asked about your health. The exact number of visits and the total length of time you'd be involved will be explained in detail by the study team, but it will span several months to track your body's response over time.

Potential risks and benefits

Taking part in a study like this could help us learn more about the best way to protect people from rabies. You would receive a vaccine that is already approved and used. As with any vaccine or medical procedure, there could be some mild side effects like soreness, redness, or swelling where you got the shot. There's also a small chance of other reactions, which the study team will discuss with you. You are free 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 rabies?

Rabies is a very serious and often deadly disease that affects the brain and spinal cord. It's usually spread through the bite of an infected animal.

What does 'intradermal' mean?

'Intradermal' means the vaccine is given just under the top layer of your skin, usually with a small needle.

What does 'intramuscular' mean?

'Intramuscular' means the vaccine is given deeper, into a muscle, which is how many common vaccines are given.

What are T cells?

T cells are a type of white blood cell that are part of your immune system. They help your body remember and fight off infections.

Will I know which vaccine method I receive?

Because this is a 'randomized controlled trial,' you might be assigned to one method or the other by chance. The study team will explain how this works.