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

Trial to evaluate the administration of IDOR-1134-2831 vaccine in healthy participants

Researchers are looking for healthy adult volunteers to take part in a new study. This study is testing a vaccine, called IDOR-1134-2831, which is designed to help protect against a germ called Clostridioides difficile, often shortened to C. difficile. C. difficile can cause severe diarrhoea and other serious gut problems, especially after taking antibiotics. This is the very first time this vaccine will be given to people, so the main aim is to check if it's safe and how the body responds to it. By understanding these early effects, scientists can decide if the vaccine should be studied further to potentially prevent C. difficile infections in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Idorsia Pharmaceuticals Ltd.

Enrolment target

Start

16 Apr 2024

Clostridioides difficile (C. difficile)

What is this study about?

This research study is about a new vaccine, called IDOR-1134-2831, which is being developed to protect against a type of germ called Clostridioides difficile (often called C. difficile). C. difficile is a common cause of serious gut infections. These infections can lead to severe diarrhoea, tummy pain, and in some cases, can be very dangerous, especially for people who have recently taken antibiotics or are in hospital.

This particular study is a very early stage of testing for the vaccine. It's called a 'Phase I' study, which means it's the first time the vaccine is being given to people. The main purpose at this stage is to find out if the vaccine is safe and how healthy people's bodies react to it. Researchers will be looking closely for any side effects and how the immune system (your body's defence system) responds to the vaccine.

Finding new ways to prevent C. difficile infections is really important because treatments can be complicated, and the infection can sometimes come back. If this vaccine proves to be safe and effective in later studies, it could offer a new way to protect people, particularly those at high risk, from this potentially serious illness.

Key takeaways

The study is testing a new vaccine against C. difficile germ.
It's an early-stage study, checking the vaccine's safety and how the body reacts.
Only healthy adults, aged 18 and over, can take part.
Participation involves receiving the vaccine and having regular health check-ups.
Taking part helps advance medical research for C. difficile prevention.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit, so adults of any age from 18 upwards can take part. Both men and women are welcome.

The research team will carry out some checks to make sure you are healthy enough to participate. This will involve reviewing your medical history and a general health check-up. The most important thing is that you are generally well and don't have any serious ongoing health problems.

Remember, the research team will decide if this study is right for you, based on all health information.

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 comfortable with having injections and blood tests?
Are you able to attend regular clinic visits for a period of time?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new vaccine, IDOR-1134-2831. Because this is the first time it will be given to humans, you would be closely monitored. This would involve several visits to the clinic or hospital over a period of time. During these visits, the research team would perform health checks, take blood samples, and ask you about how you are feeling and if you have experienced any side effects. The exact number of visits and the total length of time you would be involved in the study would be explained in detail by the research team. You would be given a study timetable showing all appointments and what would happen at each visit.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. A potential benefit of taking part is contributing to medical science and helping to develop a vaccine that could one day prevent serious C. difficile infections. While direct personal benefit might be small at this early stage, you would receive careful health monitoring. Potential risks could include side effects from the vaccine, such as pain or redness at the injection site, or feeling generally unwell, though serious side effects are rare in early-stage trials. You would receive a full explanation of all known risks before deciding to join, and you are free to withdraw from the study at any time without needing to give a reason.

Locations (1)

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

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Unverified
Germany

Common questions

What is C. difficile?

C. difficile is a type of germ that can cause serious gut infections leading to severe diarrhoea and tummy problems, especially after taking antibiotics.

What does a 'vaccine' do?

A vaccine helps your body build up its own defence system (immune system) to fight off specific germs, like C. difficile, before you get sick.

Why is this vaccine being tested on healthy people first?

In the early stages, new vaccines are often tested on healthy volunteers to make sure they are safe and to see how the body reacts to them before testing them on people who are unwell.

Will I get C. difficile from this vaccine?

No, you cannot get C. difficile infection from this vaccine. Vaccines like this are designed to teach your body to fight the germ, not to give you the infection.

How long will the study last?

The exact length of the study for each participant will be explained by the research team, but studies like this usually involve several visits over a number of months.