Ongoing, recruitingTherapeutic use (Phase IV)Interventional

YF_PROTECT: Prophylactic Treatment with Sofosbuvir for Yellow fever Exemption Circumstances and Travel

This important study, named YF_PROTECT, is exploring if a medication called Sofosbuvir could be a protective treatment for Yellow Fever. It's designed for people who might not be able to have the standard Yellow Fever vaccine due to certain health reasons, but still need protection from the virus, for example, if they need to travel to areas where Yellow Fever is present. Researchers will give Sofosbuvir to healthy volunteers and then check if the Yellow Fever virus can be found in their blood or urine, or if their body makes protective antibodies. This will help them understand if Sofosbuvir can offer an alternative way to protect against Yellow Fever for those who can't get the vaccine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

22 Aug 2024

Healthy volunteers

What is this study about?

Imagine you need to travel to a country where Yellow Fever is a risk, but for health reasons, you can't have the usual vaccine. This study, called YF_PROTECT, is trying to find a solution for situations like this. Researchers are investigating whether a medicine, called Sofosbuvir, can help protect people from Yellow Fever.

The main aim is to see if Sofosbuvir can stop the Yellow Fever virus from showing up in a person's body after they've been given a small, controlled amount of the virus (similar to how a vaccine works). They will check blood and urine samples to see if the virus is present, and also look for signs that the body has made 'neutralising antibodies' – these are special proteins that fight off the virus. This will tell them if Sofosbuvir is offering protection.

This study is important because it could provide an alternative way to protect people who can't have the standard Yellow Fever vaccine. If successful, it could offer a safer travel option for certain individuals, making sure they are protected from this serious illness.

Key takeaways

This study evaluates Sofosbuvir as a potential protective medicine for Yellow Fever.
It's for people who might not be able to get the standard Yellow Fever vaccine.
Researchers will check blood and urine for the virus and antibodies.
Participants must be healthy volunteers, aged 18 or over.
The goal is to find new ways to prevent Yellow Fever in vulnerable groups.

Who may be eligible?

This study is looking for healthy volunteers. To take part, you need to be at least 18 years old. There's no upper age limit mentioned.

Both men and women can participate in this research. The most important thing is that you are seen as healthy by the study doctors after a careful check-up.

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 healthy?
Are you able to attend clinic visits for tests?
Are you willing to take study medication (Sofosbuvir)?
Are you able to keep a diary of any symptoms?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given the medicine Sofosbuvir. You'll have regular checks over a period of time, including blood and urine tests. These tests will look for the Yellow Fever virus and signs that your body is fighting it, such as protective antibodies. You'll also need to keep a diary of any side effects you might experience and report any new or unusual symptoms. The study will involve several visits to the clinic for these tests and check-ups, and the medical team will explain the full schedule to you.

Potential risks and benefits

Potential benefits of taking part include contributing to important medical research that could offer an alternative way to protect people from Yellow Fever. However, there's always a possibility of experiencing side effects from the study medicine, Sofosbuvir. These will be carefully monitored, and you will be given information about common side effects. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your future 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
Netherlands

Common questions

What is Yellow Fever?

Yellow Fever is a serious disease spread by mosquitoes, found in parts of Africa and South America. It can cause fever, headaches, muscle pain, and in severe cases, liver damage and bleeding.

What is Sofosbuvir?

Sofosbuvir is a medicine already used to treat certain viral infections. In this study, researchers are exploring if it can also help protect against the Yellow Fever virus.

Will I get Yellow Fever in this study?

The study aims to see if Sofosbuvir can prevent the Yellow Fever virus from being detected after vaccination. The researchers will be closely monitoring you to ensure your safety.

How long will I be in the study?

The study involves checks on specific days, such as day 5 and day 28 after vaccination, but the full duration of your participation and number of visits will be explained by the study team.

What if I experience side effects?

Any side effects will be carefully monitored by the study team, and you will keep a diary to record them. It's important to report anything unusual.