AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I, Open-label, Randomized, Active-Controlled, to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old Healthy Participants in Sweden.

Researchers in Sweden are conducting an early-stage study to test a new oral vaccine called DuoChol for cholera. This is a `Phase I` study, which means it's one of the first times this vaccine is being given to people. The main goal is to see if the vaccine is safe and how well it helps the immune system, your body's defence, learn to fight off cholera infection. Healthy adults between 18 and 45 years old are taking part. Some participants will receive the new vaccine, and others will receive an existing, approved cholera vaccine for comparison. This helps researchers understand if DuoChol could be a promising new way to prevent cholera, a serious illness that causes severe diarrhoea.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

International Vaccine Institute

Enrolment target

Start

06 Oct 2025

Prevention of Cholera disease

What is this study about?

This study is about a new vaccine designed to protect people from cholera, a serious stomach illness that causes severe diarrhoea. The vaccine is called DuoChol, and it's given by mouth rather than an injection. Researchers want to find out two main things:

First, they want to check how safe DuoChol is when given to people for the first time. They will carefully watch for any side effects. Second, they want to see how well it helps your body build up protection against cholera. This means they will look at your immune system's response – your body's natural defence against illness.

This is a very early study, called a `Phase I` trial. This means it's one of the first times the vaccine is being tested in humans, so it's mainly focused on safety and understanding how it works in the body. If this study shows good results, the vaccine could move on to bigger studies to confirm its effectiveness.

Key takeaways

Tests a new oral cholera vaccine (DuoChol).
Focuses on safety and immune response.
For healthy adults aged 18-45 in Sweden.
It's a very early stage (Phase I) study.
Compares the new vaccine with an existing one.

Who may be eligible?

To join this study, you need to be a healthy adult living in Sweden. You must be between 18 and 45 years old.

The study is open to both men and women. The researchers will check your general health carefully to make sure you are suitable to take part.

They will provide more specific details about other health conditions, medications, or past medical treatments that might prevent you from joining. This ensures the study is as safe as possible for everyone involved.

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 between 18 and 45 years old?
Do you live in Sweden?
Are you generally healthy?
Are you willing to attend regular clinic visits?
Are you able to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of the first people to receive this new vaccine. You won't know if you're getting the new DuoChol vaccine or an existing cholera vaccine. You'll need to attend several appointments at the study clinic for health checks, to receive the vaccine, and to give blood samples. These samples will help researchers understand how your body responds to the vaccine.

You'll be carefully monitored for any side effects or changes in your health throughout the study. The total duration of your participation, including all visits and follow-up, will be clearly explained to you.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, as you might receive protection against cholera, or help researchers develop a new vaccine that could protect many others in the future. However, there are also potential risks, as this is a new vaccine, and some side effects may not yet be known. You might experience common vaccine side effects like a sore arm, fever, or headache, or potentially more serious reactions. You will be closely monitored for any health changes. Remember, joining a clinical trial is always your choice, and you are free to withdraw at any time without giving a reason, and it will not affect 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
Sweden

Common questions

What is cholera?

Cholera is a serious infection spread through contaminated food or water, causing severe diarrhoea and dehydration.

What does 'oral cholera vaccine' mean?

It means the vaccine is taken by mouth, usually as a liquid, rather than by an injection.

What does 'Phase I' mean for a study?

Phase I means it's a very early study, focusing on how safe the vaccine is and how it works in the body, in a small group of people.

Will I know if I'm getting the new vaccine or an older one?

No, this study is `randomized, active-controlled`, meaning you won't know which vaccine you receive, and some participants will receive an already approved vaccine.

Who is funding this study?

This information isn't provided here, but it's a good question to ask the research team if you're interested.