Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Dose-finding and safety study of a new Shigella vaccine combined with an adjuvant in the Netherlands and Zambia

This early-stage study is looking into a new vaccine designed to prevent shigellosis, a type of severe stomach infection often causing diarrhoea. The main goal is to find a safe dose and see how well healthy adults, aged 18 and over, react to it. Scientists are also watching for any side effects and checking if the vaccine helps the body build protection against the shigella bacteria. This research is happening in both the Netherlands and Zambia, as part of understanding the vaccine's effects in different populations and settings. It's a crucial first step in developing a new way to fight this common and sometimes dangerous illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Academisch Ziekenhuis Leiden

Enrolment target

Start

02 Jul 2024

Vaccination against shigellosis (in healthy adults)

What is this study about?

Shigellosis is an infection that can cause severe diarrhoea, stomach cramps, and fever. It's caused by bacteria called Shigella, and it can be particularly serious for young children and people with weakened immune systems. This study is testing a new vaccine specifically designed to help your body fight off these Shigella bacteria and prevent you from getting sick.

This is a very early stage study, sometimes called a 'Phase 1' study. At this point, the main focus is on safety. Researchers want to make sure the vaccine is safe for people to receive and to work out the best dose. They're also looking to see if the vaccine helps your body create 'antibodies' – special proteins that fight off infections. Think of it like training your immune system to recognise and attack the shigella bacteria before they can make you ill.

The study involves healthy adults from both the Netherlands and Zambia. By including people from different places, researchers can get a broader understanding of how the vaccine works and if it has similar effects across different groups. The information gathered from this study is vital. If this new vaccine proves to be safe and encouraging, it could eventually lead to a new tool to protect many people from shigellosis around the world.

Key takeaways

This study is testing a new shigellosis vaccine in healthy adults.
It's an early-stage study focused on safety and finding the right dose.
The research involves participants in the Netherlands and Zambia.
Volunteers will receive the vaccine and be closely monitored.
Taking part helps advance the development of new ways to fight serious infections.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old to be considered.

Since this is a safety study, there will be certain health conditions or medications that might mean you can't join. For example, if you have a serious ongoing health problem, are pregnant, or breastfeeding, you might not be suitable.

The research team will review your medical history and conduct health checks to make sure participating is safe for you. It's important to be completely honest about your health so they can make the best decision.

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 *not* currently pregnant or breastfeeding?
Could you attend regular appointments at a clinic?
Are you willing to provide blood samples and undergo health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new vaccine. Researchers would then monitor your health closely over a period of time. This would involve regular visits to the clinic for check-ups, blood tests, and possibly providing other samples. The number of visits and the total length of your participation would be explained in detail by the study team. You would also be asked to report any changes in your health or any side effects you might experience.

Potential risks and benefits

Potential benefits include contributing to medical science and possibly protecting yourself against shigellosis, though protection isn't guaranteed. As with any new vaccine, there could be risks like temporary pain or redness at the injection site, or more rarely, allergic reactions or other side effects. All possible risks will be explained fully. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What is shigellosis?

Shigellosis is a gut infection caused by bacteria, leading to severe diarrhoea, stomach cramps, and fever.

What does 'dose-finding' mean?

It means the researchers are trying to find the best amount of the vaccine (the dose) that is both safe and effective.

What is an 'adjuvant'?

An adjuvant is an ingredient added to some vaccines to help your body's immune system respond more strongly to the vaccine.

Is this vaccine approved for use yet?

No, this is a very early stage 'Phase 1' study. The vaccine is still being tested and is not yet available to the public.

Will I get shigellosis if I take part?

No, you will receive a vaccine designed to prevent shigellosis, not cause it. You will not be intentionally exposed to the shigella bacteria.