Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A two-centre open-label non-inferiority trial to assess the immunogenicity and safety of an intradermal and an intramuscular single-visit dosing regimen of purified chick-embryo cell-culture rabies vaccine in adults

This research is a study for adults looking at different ways to give the rabies vaccine. It's comparing a new, simpler way called 'intradermal' vaccination with the standard way, which is given into the muscle. The aim is to see if these new approaches, which only need one visit, are just as good at boosting your protection against rabies and if they are safe to use. Researchers will be checking how well the body produces protective antibodies against rabies after vaccination. This study is important for finding easier and potentially more efficient ways to protect people from rabies, especially for those who might travel to areas where rabies is a risk.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institute Of Tropical Medicine

Enrolment target

360

Start

05 Apr 2024

Rabies

What is this study about?

This study is about a very serious disease called rabies. Rabies is usually caught from the bite or scratch of an infected animal and can be deadly if not treated quickly. Thankfully, there's a vaccine that helps protect people from rabies.

Researchers in this study are looking for better ways to give this important vaccine. Currently, the most common way is to inject it into a muscle, like in your arm. This study is comparing that standard method with a new approach where the vaccine is given just under the skin (this is called 'intradermal'). They want to see if this under-the-skin injection, which might be easier and require fewer visits, works just as well as the standard injection in protecting someone from rabies. They will be carefully checking how well peoples' bodies respond to the vaccine by measuring the amount of protection (antibodies) they produce.

The main goal is to check if these new, simpler ways of giving the vaccine can boost a person's protection against rabies just as effectively as the current method. They also want to make sure these new methods are safe. Finding easier and effective ways to vaccinate could make it simpler for more people to get protected against rabies, especially for travellers or people working with animals in areas where rabies is a concern.

Key takeaways

This study is comparing different ways to give the rabies vaccine.
It aims to find simpler, one-visit vaccination methods that work just as well as the standard method.
Researchers will check how well the vaccine boosts your body's protection against rabies.
Safety is a top priority, and you will be monitored closely for any side effects.
Only adults aged 18 or over can take part.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. The study welcomes both men and women.

Generally, you should be in good health. There might be some specific reasons why you couldn't take part, like if you have certain medical conditions or are taking particular medications. The study team will discuss these with you to make sure it's safe for you to participate.

Remember, the study team will go through all the requirements with you in detail to confirm you are a good fit for this research.

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 generally in good health?
Are you able to attend multiple study visits if required?
Are you comfortable with blood tests?
Have you discussed any existing medical conditions or medications with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the rabies vaccine in one of the ways being tested. The study is designed to see how your body responds to the vaccine over time. This means you would have several scheduled visits where the study team would check your health and take blood samples. These blood samples are important for measuring the levels of protection (antibodies) your body produces against rabies.

The study involves what is called a 'single-visit dosing regimen,' meaning some parts of the vaccination process might be completed in one go, but you will still have follow-up visits. You would be carefully monitored for any side effects. The total duration of your involvement, including all visits and follow-ups, would be explained fully by the study team, but it likely involves monitoring your antibody levels for several weeks or months after the vaccination.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving the rabies vaccine and contributing to important research that might improve vaccination methods for others. However, like any medication, the rabies vaccine can have side effects, such as soreness or redness at the injection site, headache, or mild fever. The study team will carefully monitor you for any side effects and will be there to help 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 disease that affects the brain and nerves. It's usually caught from the bite of an infected animal and is almost always fatal if not treated quickly.

What is a vaccine?

A vaccine is a medicine that helps your body learn to fight off illnesses before you get sick. It trains your immune system to recognise and destroy harmful viruses or bacteria.

What does 'immunogenicity' mean?

Immunogenicity is a medical term for how well your body creates protection (like antibodies) after getting a vaccine. In this study, they want to see if the new vaccine methods produce good protection.

What is the difference between an 'intradermal' and 'intramuscular' injection?

An 'intramuscular' injection goes deep into your muscle (like in your arm). An 'intradermal' injection goes just under the top layer of your skin. This study is comparing these two ways.

Will I get paid to be in this study?

This information is not available in the provided summary. You should ask the study team directly if there is any compensation for your time and travel.