Study Comparing Intradermal and Intramuscular Rabies Vaccination with Inactivated Rabies Virus for Patients Needing a Booster Dose

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What is this study about?

This clinical trial is focused on studying rabies, a serious disease caused by a virus that affects the brain and can be fatal if not treated promptly. The study will compare two different methods of administering a rabies vaccine called Rabipur. This vaccine contains an inactivated form of the rabies virus, which means the virus is not alive and cannot cause the disease. The trial will look at how the vaccine works when given in two ways: intradermally, which means injecting it just under the skin, and intramuscularly, which means injecting it into a muscle.

The purpose of the study is to understand how these two methods of vaccination affect the body’s immune response, particularly focusing on a type of immune cell called T cells. These cells are important for fighting infections. The study will measure the number of these cells that remain in the skin after vaccination, as well as other immune responses over time. Participants will receive either the intradermal or intramuscular vaccine and will be monitored for changes in their immune system.

The study will take place over several months, with participants receiving a series of vaccinations and follow-up visits to monitor their immune response. The goal is to determine which method of vaccination is more effective in producing a strong and lasting immune response against rabies. This information could help improve rabies vaccination strategies in the future.

1 joining the trial

Upon joining the trial, you will be asked to provide written informed consent. This means you agree to participate and understand the details of the study.

You will be required to share your medical history and records, which will be discussed when relevant to the study.

2 initial assessment

An initial health assessment will be conducted to ensure you meet the criteria for participation. This includes confirming your age, health status, and other eligibility requirements.

You must not have any acute illness at the time of recruitment and, if applicable, agree to use contraception during the trial.

3 vaccination schedule

You will receive a rabies vaccine called Rabipur, which is an inactivated rabies virus vaccine. It will be administered as a solution for injection.

The vaccine will be given intramuscularly, meaning it will be injected into a muscle.

4 follow-up visits

You will have several follow-up visits to monitor your response to the vaccine. These visits will include blood tests to measure your immune response.

The primary focus is to assess the number and proportion of specific immune cells in your skin and blood after the booster dose.

5 booster dose

A booster dose of the vaccine will be administered to enhance your immune response. This will occur at a specified time during the trial.

Your immune response will be measured again after the booster dose to evaluate the effectiveness of the vaccination route.

6 final assessment

At the end of the trial, a final assessment will be conducted to gather all necessary data on your immune response.

This will include a comprehensive review of your health status and any changes observed during the trial.

Who Can Join the Study?

Must be between 18 and 50 years old.
For the Pilot Group: Must have had a completed or partly completed schedule of rabies vaccination more than one month before joining the study.
For the Pilot Group: Body Mass Index (BMI) must be 30 or less. BMI is a measure of body fat based on height and weight.
For the Pilot Group: Must be able and willing to provide written consent to participate.
For the Pilot Group: Must not have any acute illness at the time of joining the study. Acute illness means a sudden and severe illness.
For the Main and Pilot Groups: Women who can have children must agree to use contraception during the study.
For the Pilot Group: Must not be pregnant or planning to become pregnant during the study.
For the Healthy Control Group: Must be able and willing to provide written consent to participate.
For the Healthy Control Group: Must agree to share and discuss their medical history and records when needed.
For the Healthy Control Group: Must not have any acute illness at the time of joining the study.
For the Main Group: Body Mass Index (BMI) must be 30 or less.
For the Main Group: Must agree not to donate blood or receive other vaccinations for 30 days after each vaccination in the study.
For the Main Group: Must agree to share and discuss their medical history and records when needed.
For the Main Group: Must be able and willing to provide written consent to participate.

Who Cannot Join the Study?

Having an active infection or illness at the time of the study.
Having a history of severe allergic reactions, especially to vaccines.
Being pregnant or planning to become pregnant during the study period.
Having a weakened immune system, which means your body has a harder time fighting infections.
Taking medications that suppress the immune system, such as steroids.
Having received another vaccine within a certain time frame before the study.
Participating in another clinical trial at the same time.
Having a history of drug or alcohol abuse.
Having any condition that the study doctors believe would make it unsafe for you to participate.

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
Ufqrbwnqkw Ov Abrjqxp	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.01.2024

Trial locations

Rabies Vaccine is a medication used to protect against rabies, a serious virus that affects the brain and nervous system. In this trial, the vaccine is given in two different ways: intradermally, which means it’s injected just under the skin, and intramuscularly, which means it’s injected into a muscle. The goal is to see which method helps the body create more memory T cells, which are a type of immune cell that helps the body remember and fight off the rabies virus if it is encountered again in the future.

Investigated diseases:

Rabies

Rabies – Rabies is a viral disease that affects the central nervous system. It is primarily transmitted through the bite of an infected animal. The virus travels from the site of the bite through the nerves to the brain. Initial symptoms may include fever and a tingling sensation at the site of exposure. As the disease progresses, neurological symptoms such as confusion, agitation, and hallucinations may occur. Eventually, the disease can lead to paralysis and other severe neurological complications.

Trial ID:

2023-507065-26-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Intradermal and Intramuscular Rabies Vaccination with Inactivated Rabies Virus for Patients Needing a Booster Dose

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?