Study Comparing the Safety and Immune Response of the Investigational vYF Vaccine and Stamaril for Yellow Fever in Adults in Europe and Asia

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What is this study about?

This clinical trial is focused on studying Yellow Fever, a viral infection that can cause serious illness. The study is comparing two vaccines: the investigational vYF vaccine and the already available Stamaril vaccine. Both vaccines are designed to protect against Yellow Fever by helping the body build immunity to the virus.

The purpose of the study is to compare the immune response generated by the vYF vaccine to that of the Stamaril vaccine. Participants will receive one dose of either the vYF vaccine or the Stamaril vaccine. The study will monitor the participants’ immune response over time, specifically looking at how well their bodies produce antibodies, which are proteins that help fight infections. The study will also track any side effects or reactions to the vaccines.

Participants in the study will be observed for a period of time to assess the effectiveness and safety of the vaccines. This includes checking for any immediate reactions after vaccination and monitoring for any side effects over the following months. The study aims to ensure that the new vYF vaccine is as effective and safe as the existing Stamaril vaccine in providing protection against Yellow Fever.

1 initial vaccination

On the first day of the study, you will receive a single dose of either the investigational vYF vaccine or the control vaccine called Stamaril. Both vaccines are administered as an injection under the skin, known as subcutaneous use.

The purpose of this step is to evaluate the body’s immune response to the vaccine, specifically looking at the production of antibodies against yellow fever.

2 monitoring period

After receiving the vaccine, you will be observed for any immediate reactions for 30 minutes. This is to ensure your safety and to monitor for any potential side effects.

You will be asked to report any symptoms or reactions you experience after the vaccination, such as pain at the injection site, fever, headache, or muscle aches.

3 follow-up visit

Approximately 28 days after the vaccination, you will return for a follow-up visit. During this visit, a blood sample will be taken to measure the level of antibodies in your blood.

This step is crucial to determine if the vaccine has successfully triggered an immune response, which is indicated by a significant increase in antibody levels.

4 extended follow-up

You will have additional follow-up visits scheduled at various intervals, including 6 months, 1 year, and annually up to 5 years after the initial vaccination.

These visits will involve blood tests to monitor the long-term immune response and to ensure continued protection against yellow fever.

5 reporting adverse events

Throughout the study, you are encouraged to report any adverse events or side effects you experience. This includes any unexpected symptoms or health issues that arise during the trial period.

The information collected will help assess the safety of the vaccine and identify any potential risks associated with its use.

Who Can Join the Study?

Must be between 18 and 60 years old. This means you can join from your 18th birthday until the day before your 60th birthday.
Must be able to attend all scheduled visits and follow all study procedures.
If you are a female who can have children, you must have a negative pregnancy test before receiving the vaccine on Day 1. The test will be repeated on Day 29 to ensure you are still not pregnant within 28 days of getting the vaccine.
If you are a female, you must not be pregnant or breastfeeding. You must either be unable to have children (for example, postmenopausal for at least 1 year or surgically sterile) or agree to use an effective birth control method or abstain from sex starting at least 4 weeks before getting the vaccine until at least 4 weeks after. Note: For French participants, contraception must be used for 12 weeks after getting the vaccine.
You must sign and date an informed consent form. If you are under 21 years old in Singapore, your parent(s) or another legally acceptable representative must also sign and date the form.
If you are part of the additional group in Asian countries, you must have at least one biological parent of Chinese origin, which you will report yourself.

Who Cannot Join the Study?

Participants who have had a previous vaccination against yellow fever cannot join the study. Yellow fever is a viral infection spread by mosquitoes.
Individuals with a known allergy to any component of the vaccine will be excluded. An allergy is when your body reacts negatively to a substance.
People with a weakened immune system cannot participate. The immune system is the body’s defense against infections.
Pregnant or breastfeeding women are not allowed to join the study.
Participants with a history of severe reactions to vaccines will be excluded. A severe reaction is a strong negative response to a vaccine.
Individuals currently participating in another clinical trial cannot take part in this study.
Anyone with a serious illness that requires ongoing medical treatment will be excluded. A serious illness is a health condition that significantly affects your daily life.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland
Klinikum Der Universitat Munchen AöR	Munich	Germany
Rostock University Medical Center	Rostock	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Berliner Centrum Fur Reise Und Tropenmedizin GmbH	Berlin	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fta Stafkh rxpqjbgtazlxoz Oz	Turku	Finland
Abdtvhyhdz Pmgqensy Htvrgpft Dy Pvlso	Paris	France
Hjlpnqhk Ukfsmtqasd Ciekyep Hznoxxfm	Helsinki	Finland
Bsgsbzwzrnyfizymdrjucop Fwgx Tfgyjtcjqbmvs	Hamburg	Germany
Mzrkqncu Httcoeug	Helsinki	Finland
Fkcahifmx Pyji Lp Igboeioafnjcn Bdbchxzuj Dgo Hggabqob Uvoefpsroikeo Lt Pcx	Madrid	Spain
Cfb Cpynm Rqaeqqqanwy	Lyon	France
Hhkbqdcs Vbwl degzokuq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	02.07.2021
France	Not recruiting	02.07.2021
Germany	Not recruiting	02.07.2021
Spain	Not recruiting	02.07.2021

Trial locations

Investigated drugs:

vYF is an investigational vaccine being tested in this clinical trial. It is designed to help the body build immunity against yellow fever, a viral infection transmitted by mosquitoes. The vaccine works by stimulating the immune system to produce antibodies, which are proteins that can recognize and fight the yellow fever virus if the person is exposed to it in the future. In this study, the effectiveness of vYF is being compared to another vaccine to see if it provides a similar level of protection.

Stamaril® is a vaccine used as a control in this clinical trial. It is an established vaccine that helps protect against yellow fever by prompting the immune system to produce antibodies against the virus. Stamaril® is used as a benchmark in the study to compare the immune response it generates with that of the investigational vaccine, vYF. This comparison helps researchers determine if the new vaccine is as effective as the existing one in preventing yellow fever.

Investigated diseases:

Yellow fever

Yellow fever – Yellow fever is a viral infection transmitted by mosquitoes, primarily found in tropical and subtropical areas of Africa and South America. The disease begins with symptoms such as fever, chills, loss of appetite, nausea, muscle pains, and headaches. As the disease 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, potentially leading to organ failure. The progression of yellow fever varies, with some individuals recovering completely while others may experience more severe symptoms.

Trial ID:

2022-502047-35-00

Protocol code:

VYF03

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing the Safety and Immune Response of the Investigational vYF Vaccine and Stamaril for Yellow Fever in Adults in Europe and Asia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?