Study Comparing Different Injection Methods of Yellow Fever Vaccine in Adults

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What is this study about?

This clinical trial is focused on studying yellow fever, a viral infection transmitted by mosquitoes, which can cause symptoms ranging from fever and chills to more severe complications. The study will use a vaccine called STAMARIL®, which contains a live, weakened form of the yellow fever virus strain 17D-204. The purpose of the study is to compare how well the vaccine works when given through different methods: under the skin (intradermal), into the muscle (intramuscular), and under the skin (subcutaneous).

Participants in the study will receive the STAMARIL® vaccine in one of these three ways. The study will observe the body’s immune response, specifically looking at the presence of certain immune cells in the skin and blood after vaccination. The study will also monitor any side effects that occur after receiving the vaccine. The goal is to understand which method of vaccination is most effective in producing a strong immune response against yellow fever.

The study will take place over a period of time, with participants being monitored for their immune response and any side effects up to 120 days after vaccination. This research aims to provide valuable information on the best way to administer the yellow fever vaccine to ensure maximum protection against the disease.

1 initial vaccination

Upon joining the study, you will receive a vaccination against yellow fever. This vaccine is called STAMARIL® and contains a live, weakened form of the yellow fever virus strain 17d-204.

The vaccine will be administered as a suspension for injection. The method of injection will be randomly assigned and could be either subcutaneous (under the skin), intradermal (into the skin), or intramuscular (into the muscle).

2 post-vaccination monitoring

After receiving the vaccine, you will be monitored for any immediate reactions. This is a standard procedure to ensure your safety and well-being.

You will be asked to refrain from donating blood and receiving other vaccinations for 30 days following the vaccination.

3 follow-up visits

You will have follow-up visits scheduled to monitor your health and the immune response to the vaccine. These visits will occur on Day 0 (the day of vaccination), Day 14, Day 28, and Day 120.

During these visits, blood samples may be taken to measure the immune response, including the presence of specific cells and antibodies related to the yellow fever virus.

4 adverse event monitoring

Throughout the study, any side effects or adverse events will be recorded. These could be local reactions at the injection site or systemic reactions affecting the whole body.

You will be asked to report any side effects you experience up to Day 28 after vaccination. Serious adverse events will be monitored up to Day 120.

5 study completion

The study is expected to conclude by July 31, 2026. Your participation will help in understanding the immune response to different methods of yellow fever vaccination.

Upon completion, you may receive information about the study results and your contribution to the research.

Who Can Join the Study?

Must be between 18 and 50 years old.
Body Mass Index (BMI) must be between 18.5 and 30 kg/m². BMI is a measure of body fat based on height and weight.
Must agree not to donate blood or receive other vaccinations for 30 days after the study vaccination.
Must agree to share and discuss their medical history and records when necessary.
Must be able and willing to provide written informed consent. This means you understand the study and agree to participate.
If you are a woman who can have children, you must agree to use a highly effective method of contraception for up to 30 days after the study vaccination.

Who Cannot Join the Study?

People who have had a severe allergic reaction to a previous yellow fever vaccine.
Individuals with a weakened immune system, which means their body has a harder time fighting infections.
Pregnant women or those who are breastfeeding.
Children under 9 months of age.
People with a history of problems with their thymus, a small organ in the chest that helps the immune system.
Anyone currently experiencing a fever or an active infection.
Individuals who have received another live vaccine within the last 4 weeks.
People who are allergic to eggs, as the vaccine may contain egg proteins.
Anyone who has a history of severe allergies to any component of the vaccine.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Institute Of Tropical Medicine	Antwerp	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	27.01.2025

Trial locations

Investigated drugs:

YELLOW FEVER VIRUS STRAIN 17D-204 (LIVE, ATTENUATED)

Yellow Fever Vaccine is a vaccine used to protect against yellow fever, a viral infection spread by mosquitoes. In this clinical trial, the vaccine is being studied to see how well it works when given in different ways: into the skin (intradermal), under the skin (subcutaneous), or into the muscle (intramuscular). The goal is to understand which method of giving the vaccine helps the body create the best immune response, specifically looking at certain immune cells in the skin that remember the virus and help protect against future infections.

Investigated diseases:

Yellow fever

Yellow fever – Yellow fever is a viral infection transmitted by mosquitoes, primarily found in tropical regions of Africa and South America. The disease begins with symptoms such as fever, chills, loss of appetite, nausea, muscle pains, and headaches. As it progresses, some individuals may experience a brief recovery period followed by a return of fever, abdominal pain, and liver damage, which can lead to jaundice. In severe cases, bleeding from the mouth, nose, eyes, or stomach may occur. The virus affects the liver and kidneys, causing a range of symptoms that can vary in intensity. The progression of yellow fever can lead to significant organ damage if not managed properly.

Trial ID:

2024-514154-73-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Different Injection Methods of Yellow Fever Vaccine in Adults

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