Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Recruiting
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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- 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 trial?
10 criteria
- 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.
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Investigated drugs
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.
What is already known about the treatment
BCG vaccine – A vaccine administered via intradermal injection to provide protection against tuberculosis. It contains a weakened strain of Mycobacterium bovis, which stimulates the immune system without causing disease. BCG (Bacillus Calmette-Guérin) is widely used globally as part of tuberculosis prevention programs, particularly in countries with high TB prevalence. The vaccine works by triggering the production of memory T-cells that recognize and fight Mycobacterium tuberculosis, though its effectiveness varies by population and geographic region. It is classified as an immunizing agent and remains the only approved vaccine against tuberculosis, though research continues to develop more effective alternatives.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514428-18-00Estimated enrolment50 patientsSponsorLeids Universitair Medisch Centrum (LUMC)
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