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Study on Sofosbuvir for Preventing Yellow Fever in Healthy Volunteers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called sofosbuvir on Yellow Fever, a viral infection transmitted by mosquitoes. The study involves healthy volunteers who will receive a treatment with Sovaldi 400 mg film-coated tablets, which contain the active substance sofosbuvir. Sofosbuvir is known as an RNA polymerase inhibitor, which means it works by blocking the virus from multiplying in the body.

The purpose of the study is to assess how sofosbuvir affects the replication of the YF17D virus, a strain of the Yellow Fever virus. Participants in the study will be monitored for the presence of the virus in their blood and urine, as well as the development of neutralizing antibodies, which are proteins that help fight off infections. The study will also look at any side effects of sofosbuvir, such as changes in liver function tests and blood counts, to ensure the safety of the treatment.

The study will take place over several months, during which participants will receive the medication and undergo regular check-ups to monitor their health and the effects of the treatment. The goal is to gather information on the potential use of sofosbuvir as a preventive treatment for Yellow Fever, especially in situations where vaccination is not possible or practical. This research could provide valuable insights into new ways to protect people from this serious disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age (18-50 years) and general health status. You must be generally healthy without significant health issues.

    A healthcare professional will explain the study details, including the purpose, procedures, and any potential risks. You will have the opportunity to ask questions and provide informed consent to participate.

  2. Step 2

    Medication administration

    You will be given a medication called sofosbuvir, which comes in the form of 400 mg film-coated tablets. This medication is taken orally.

    The frequency and duration of taking sofosbuvir will be explained to you during the initial visit. It is important to follow the instructions provided by the healthcare team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, you will have regular follow-up visits. These visits are designed to monitor your health and the effects of the medication.

    You will be asked to report any side effects or changes in your health. A diary with a symptom questionnaire will be provided to help track any adverse events.

  4. Step 4

    Blood and urine tests

    During the study, blood and urine samples will be collected at specific times to check for the presence of the yellow fever virus and to measure your body's response to the medication.

    These tests will help determine if the medication is effective in preventing the replication of the yellow fever virus.

  5. Step 5

    Final assessment

    At the end of the study, a final assessment will be conducted. This will include a review of your health status and any changes observed during the study.

    The healthcare team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

3 criteria

  • Participants must be of male or female sex.
  • Participants must be between 18 and 50 years old.
  • Participants should be generally healthy without significant other health issues. This means no major problems with the immune system, which is the body's defense against infections. If you have a long-term health condition that is stable and hasn't required a change in treatment or a hospital visit in the last six weeks, you might still be able to join. The decision will be made by the doctor in charge of the study.

Who cannot join the trial?

3 criteria

  • Participants must be healthy volunteers. This means you should not have any ongoing medical conditions.
  • Both men and women can participate in the study.
  • Participants should not be part of a vulnerable population. This means you should not be in a group that needs special protection, like children or people who cannot make decisions for themselves.
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Investigated drugs

Sofosbuvir is a medication used in this clinical trial to see how it affects the replication of the yellow fever virus. It is usually used to treat hepatitis C, a liver infection caused by a virus. In this trial, researchers are testing if it can also help prevent or reduce the replication of the yellow fever virus in people who might be exposed to it. The goal is to see if taking sofosbuvir can protect people from getting sick with yellow fever, especially in situations where they might be at risk, like traveling to areas where the disease is common.

What is already known about the treatment

Sofosbuvir – Sofosbuvir is administered orally in the form of a tablet. It is currently being studied for its potential use in preventing yellow fever, particularly in healthy volunteers who may be exposed to the virus. The main therapeutic indication being explored is its ability to inhibit the replication of the yellow fever virus. At the molecular level, sofosbuvir works by interfering with the virus's ability to multiply, targeting a specific enzyme essential for viral replication. It is classified pharmacologically as an antiviral medication.

Investigated diseases

Yellow Fever – Yellow fever is a viral infection transmitted by mosquitoes. It primarily affects the liver and kidneys, causing fever, chills, loss of appetite, nausea, muscle pains, and headaches. As the disease progresses, it can lead to jaundice, which is a yellowing of the skin and eyes due to liver damage. The virus replicates in the lymph nodes and spreads to the bloodstream, affecting various organs. In some cases, the disease can cause bleeding due to liver dysfunction. The immune system typically responds by producing antibodies to fight the virus.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510949-34-00Estimated enrolment30 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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