Study on Immune Response to Intradermal Ixiaro Vaccine in Healthy Adults Aged 18-64

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What is this study about?

This clinical trial is focused on studying the immune response to the IXIARO vaccine, which is used to protect against Japanese encephalitis. Japanese encephalitis is a viral infection that affects the brain and is transmitted through mosquito bites. The study involves healthy adults aged 18 to 64 who have not previously received a Japanese encephalitis vaccination. The purpose of the study is to determine if administering the vaccine into the skin (intradermally) is as effective as the traditional method of injecting it into the muscle (intramuscularly).

Participants in the study will receive a single dose of the IXIARO vaccine. The study will compare the immune response generated by the two different methods of administration by measuring the levels of neutralizing antibodies in the blood. Antibodies are proteins produced by the immune system to help fight infections. The study will also look at other aspects of the immune response, such as the presence of certain immune cells and any side effects experienced by participants.

The trial aims to provide valuable information on whether the intradermal method of administering the IXIARO vaccine can be a viable alternative to the intramuscular method. This could potentially offer a more efficient way to deliver the vaccine, especially in areas where Japanese encephalitis is common. The study is expected to continue until the end of 2029, with the goal of improving vaccination strategies against this serious disease.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must be between 18 and 64 years old and in general good health, as determined by a medical history review and physical examination.

2 initial visit

During the initial visit, you will receive a dose of the Ixiaro vaccine. This vaccine is given as a suspension for injection and will be administered intradermally, which means it is injected into the skin.

The purpose of this is to study the immune response, specifically the levels of neutralizing serum antibodies, which are proteins in your blood that help fight infections.

3 follow-up visits

You will need to attend all scheduled follow-up visits. These visits are important to monitor your health and the immune response to the vaccine.

During these visits, blood samples may be taken to measure the levels of antibodies and to study other immune responses.

4 monitoring and reporting

Throughout the study, you will be monitored for any side effects or adverse events. It is important to report any health changes you experience during the study period.

The study aims to compare the immune response and side effects of the intradermal administration of the vaccine with the traditional intramuscular method.

5 completion of the study

The study is expected to continue until the end of 2029. Your participation will contribute to understanding the effectiveness and safety of the intradermal administration of the Ixiaro vaccine.

Upon completion, you may receive information about the study results and any relevant findings related to your health.

Who Can Join the Study?

Participants must be 18 to 64 years old.
Participants should be in general good health, which will be checked through their medical history and a physical examination.
Participants need to provide written informed consent, which means they agree to take part in the study after understanding what it involves.
Females of childbearing potential must agree to use a reliable method of birth control during the study. This can be a hormonal method (like birth control pills) or a barrier method (like condoms). Choosing not to have sex (abstinence) is also acceptable.
Participants must be available for all scheduled visits during the study.
Participants must have no previous vaccination for Japanese encephalitis.

Who Cannot Join the Study?

Individuals who are not between the ages of 18 and 64.
Individuals who do not have general good health.
Individuals who are part of a vulnerable population. This means groups of people who might need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

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Site Name	City	Country	Status
Hpoumxvy Usdetsixdg Crzzbgl Hmhsrfye	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.02.2016

Trial locations

Ixiaro is a vaccine used to protect against Japanese encephalitis, a viral infection that can cause inflammation of the brain. In this clinical trial, the vaccine is being tested to see if it can be given in a different way, specifically through the skin (intradermally), rather than the usual method of injection into the muscle (intramuscularly). The goal is to determine if this new method of administration can produce a similar immune response, which is measured by the level of protective antibodies in the blood. This could potentially make the vaccination process easier and more comfortable for patients.

Japanese Encephalitis – Japanese Encephalitis is a viral infection that affects the brain. It is caused by the Japanese Encephalitis virus, which is transmitted through mosquito bites. The disease often begins with symptoms such as fever, headache, and vomiting. As it progresses, it can lead to swelling of the brain, resulting in confusion, seizures, or movement disorders. In some cases, individuals may experience stiffness in the neck or become unresponsive. The progression of the disease can vary, with some individuals recovering fully while others may experience long-term neurological issues.

Trial ID:

2024-519876-17-00

Protocol code:

Ixiaro i.d. – IdIx

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Immune Response to Intradermal Ixiaro Vaccine in Healthy Adults Aged 18-64

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