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Study on Immune Response Differences to Meningococcal Group B Vaccine in Healthy Transgender and Cisgender Adults Aged 18-40

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how the immune system responds to a vaccine called Bexsero, which is used to protect against a type of bacteria known as Neisseria meningitidis group B. This bacteria can cause serious infections like meningitis, an inflammation of the protective membranes covering the brain and spinal cord. The study involves healthy individuals, both transgender and cisgender, aged between 18 and 40 years. The purpose of the study is to explore any differences in immune responses between these groups after receiving the vaccine.

Participants in the study will receive two doses of the Bexsero vaccine. The vaccine is given as an injection into the muscle. The study will last for a total of 56 days, during which participants will have their blood tested to measure the levels of antibodies, which are proteins made by the immune system to fight infections. These tests will help researchers understand how well the vaccine works in different people.

The study will also look at how certain immune cells, called T cells, respond to the vaccine. T cells are a type of white blood cell that play a crucial role in the immune system by helping to protect the body against infections. By comparing the immune responses of transgender and cisgender participants, the study aims to provide valuable insights into how gender and sex may influence the effectiveness of the Bexsero vaccine.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, you will attend an initial visit where you will be asked to provide written consent. This consent confirms your understanding and agreement to participate in the study.
During this visit, your general health will be evaluated through a medical history review and a physical examination to ensure you meet the study's health criteria.
Step 2
First vaccination
You will receive the first dose of the Bexsero vaccine, which is a suspension for injection. This vaccine is administered as an intramuscular injection, meaning it is injected into a muscle.
The purpose of this vaccine is to study immune responses to the meningococcal group B bacteria.
Step 3
Follow-up visit
Approximately 28 days after the first vaccination, you will return for a follow-up visit. During this visit, blood samples will be collected to measure your immune response to the vaccine.
These samples will help in understanding how your body is responding to the vaccination.
Step 4
Second vaccination
You will receive a second dose of the Bexsero vaccine, again administered as an intramuscular injection.
This second dose is important for evaluating the consistency and strength of the immune response.
Step 5
Final follow-up visit
56 days after the first vaccination, you will attend a final follow-up visit. Blood samples will be collected again to assess the long-term immune response.
This visit concludes the active participation phase of the study, and the collected data will contribute to understanding the differences in immune responses.

Who can join the trial?

8 criteria

Participants must provide a written signed informed consent form before any study-related activities begin. This means you agree to take part in the study after being informed about it.
Participants must be aged between 18 and 40 years at the time of signing the consent form.
Participants should be in good general health, as determined by a medical evaluation, which includes reviewing your medical history and a physical examination.
Participants must have a Body Mass Index (BMI) between 18.5 and 35. BMI is a measure of body fat based on height and weight.
Participants who are potentially capable of becoming pregnant (POCBP) should not be pregnant, breastfeeding, or planning to become pregnant during the study.
Transgender participants need to be on stable gender-affirming hormone therapy for at least 6 months, with compliance confirmed by hormone level tests.
POCBP must have a negative urine pregnancy test at each vaccination visit.
Participants must be willing and able to follow the study procedures and attend follow-up visits as required by the study protocol.

Who cannot join the trial?

4 criteria

Participants must be healthy volunteers. This means they should not have any significant health issues.
Participants must be between the ages of 18 to 40 years.
Both transgender and cisgender individuals can participate. Transgender refers to people whose gender identity is different from the sex they were assigned at birth, while cisgender refers to people whose gender identity matches their sex assigned at birth.
Participants must not be part of a vulnerable population. This means they should not be in a situation that makes it hard for them to make decisions about their participation, like being in prison or having a mental disability.

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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

4CMenB is a vaccine designed to protect against infections caused by a specific type of bacteria known as meningococcal serogroup B. This vaccine works by helping your immune system recognize and fight off the bacteria if you are exposed to it in the future. In this clinical trial, the vaccine is being used to study how different groups of people, specifically transgender and cisgender individuals, respond to it. The goal is to understand any differences in immune responses between these groups after receiving the vaccine.

What is already known about the treatment

4CMenB – This medication is administered as an injection to help protect against meningococcal disease caused by serogroup B bacteria. It is currently used in clinical trials to study immune responses in healthy transgender and cisgender individuals. The main purpose of this vaccine is to stimulate the body's immune system to recognize and fight off the bacteria if exposed in the future. It works by introducing small, harmless parts of the bacteria to the body, which helps the immune system learn to identify and attack the real bacteria. This vaccine is classified as a preventive vaccine, designed to boost the immune system's ability to fight specific infections.

Investigated diseases

Healthy volunteers – Healthy volunteers are individuals who do not have the disease or condition being studied. They participate in clinical trials to help researchers understand the effects of a new treatment or intervention. These individuals are typically in good health and do not have any significant medical conditions. Their participation helps establish a baseline for comparison with participants who have the disease or condition. Healthy volunteers contribute to the understanding of normal biological processes and the safety of new treatments. They are essential for the initial phases of clinical research.