Study on BCG Vaccine and Rabies Virus (Inactivated) for Healthy Volunteers: Exploring Pre-Vaccination Immune Status and Its Impact on Vaccine Response

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What is this study about?

This study focuses on understanding the immune response to BCG vaccination. The Bacillus Calmette-Guérin (BCG) vaccine is primarily known for preventing tuberculosis. The purpose of the research is to determine whether a person’s pre-vaccination immune status can predict how effectively they will respond to the vaccine. Healthy individuals who have never been exposed to tuberculosis will receive the BCG vaccine, and their immune responses will be carefully monitored.

During the study, participants will undergo blood tests before vaccination to establish their baseline immune profile. After receiving the BCG vaccine, additional blood samples and possibly small skin biopsies will be collected to analyze how the immune system responds. These samples will be examined using various laboratory techniques, including a test called mycobacterial growth inhibition assay (MGIA), which measures how effectively a person’s immune system can control the growth of mycobacteria (the type of bacteria related to tuberculosis).

The research will also include comparison with immune responses to another vaccine called Rabipur (a rabies vaccine) to better understand different types of immune protection. By analyzing the relationship between pre-vaccination immune status and post-vaccination immune responses, this study aims to improve our understanding of how vaccines work and potentially help develop more effective vaccination strategies in the future.

1 Initial vaccination visit

You will receive two vaccines during this first visit: BCG vaccine (containing Mycobacterium bovis, Danish strain 1331) and Rabipur (rabies vaccine containing inactivated rabies virus).

The BCG vaccine will be given as a suspension for injection. This is a vaccine commonly used to protect against tuberculosis.

The Rabipur vaccine will be administered as an injection to protect against rabies virus.

Blood samples will be collected to establish your baseline immune status before vaccination.

2 Post-vaccination follow-up visits

You will return for multiple follow-up visits at specific timepoints after vaccination.

During these visits, blood samples will be collected to monitor changes in your immune response to the vaccines.

A small dermal biopsy (a tiny sample of skin tissue) will be taken to examine how your skin cells are responding to the vaccination.

Your blood samples will be tested using a laboratory method called MGIA (Mycobacterial Growth Inhibition Assay), which measures how well your immune system can control the growth of mycobacteria after vaccination.

3 Immune response measurements

Your immune response to the BCG vaccine will be measured by how well your blood cells can control mycobacterial growth in laboratory tests.

Your immune response to the Rabipur vaccine will be measured by testing for neutralizing antibodies (proteins your body makes that can block the rabies virus).

Researchers will analyze different types of immune cells in your blood and skin samples and measure their activity.

The metabolic state (energy usage patterns) of your immune cells will be analyzed and correlated with how well they function.

4 Study completion

The study is scheduled to run from August 2025 to August 2027.

Your participation will involve multiple visits over a period of several months following vaccination.

At the conclusion of your participation, a final assessment of your immune response to both vaccines will be completed.

Who Can Join the Study?

You must be a healthy volunteer between 18 and 55 years old
You must be able to sign and understand the informed consent document
You must be willing and able to follow all study procedures and requirements
You must be negative for tuberculosis, which will be confirmed by a blood test called QuantiFERON®-TB Gold In-Tube test during screening
You must be negative for HIV, which will be confirmed by a test during screening

Who Cannot Join the Study?

You cannot participate if you have an acute illness at the time of enrollment (this means you are currently sick).
You cannot participate if you have received any vaccinations within 4 weeks before the study begins.
You cannot participate if you have a chronic medical condition that might affect your immune system (long-term health problems like diabetes, heart disease, or autoimmune disorders).
You cannot participate if you are taking medications that suppress your immune system (these are drugs that reduce your body’s ability to fight infections).
You cannot participate if you have a history of anaphylaxis (severe, potentially life-threatening allergic reaction) to vaccines.
You cannot participate if you are pregnant or breastfeeding.
You cannot participate if you have participated in another clinical trial within the last 30 days.
You cannot participate if you have donated blood within 8 weeks before the study.
You cannot participate if you have a known allergy to any component of the vaccine being studied.
You cannot participate if you have a history of drug or alcohol abuse that might affect your ability to follow the study protocol.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Lgepp Udhoiaaojxbh Mxkmqdm Cjzduou (oiccn	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.08.2025

Trial locations

Investigated drugs:

Mycobacterium Bovis, Danish Strain 1331

BCG (Bacillus Calmette-Guérin) vaccine is a vaccine primarily used to protect against tuberculosis. In this study, researchers are examining how a person’s immune system status before receiving the BCG vaccine might predict how well their body responds to the vaccination. The vaccine works by stimulating the immune system to develop protection against tuberculosis bacteria.

Tuberculosis – Tuberculosis is an infectious disease caused by the bacterium Mycobacterium tuberculosis that primarily affects the lungs, but can also impact other parts of the body. The infection typically begins when a person inhales droplets containing the bacteria. In most infected individuals, the immune system can contain the bacteria, resulting in latent tuberculosis where people are not sick and cannot transmit the disease. However, in some cases, the infection progresses to active tuberculosis, characterized by symptoms including persistent cough, weight loss, night sweats, and fever. Tuberculosis develops gradually, with the bacteria slowly multiplying in the body, potentially taking weeks or months before symptoms become noticeable.

Rabies – Rabies is a viral disease that causes inflammation of the brain and is typically transmitted through the bite of an infected animal. The virus travels from the wound site along the peripheral nerves to the central nervous system. After initial infection, there may be a variable incubation period during which the person remains asymptomatic. As the disease progresses, early symptoms include fever, headache, and general discomfort. The disease then advances to neurological symptoms such as anxiety, confusion, agitation, and eventually paralysis. Rabies affects the function of the brain and nervous system, leading to progressive neurological deterioration.

Trial ID:

2024-514428-18-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on BCG Vaccine and Rabies Virus (Inactivated) for Healthy Volunteers: Exploring Pre-Vaccination Immune Status and Its Impact on Vaccine Response

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?