Not recruitingRare disease

Study on the Safety and Immune Response of MenABCWY Vaccine in Healthy Adolescents Aged 11-14 with Meningococcal Meningitis

Fast replyInvestigationalNo placebo

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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 studying a disease called meningococcal meningitis, which is a serious infection that affects the protective membranes covering the brain and spinal cord. The study is testing a vaccine known as MenABCWY, which is designed to protect against several groups of bacteria that can cause this disease. The vaccine is given as an injection and is being tested to see how well it works and how safe it is for use in healthy adolescents aged 11 to 14 years.

The purpose of the study is to understand the immune response, which is how the body defends itself against infections, to two doses of the MenABCWY vaccine. The study will look at different schedules for giving the vaccine, specifically at 0 and 24 months, and at 0 and 48 months. Participants will receive the vaccine through an injection into the muscle, and the study will monitor their health and any reactions to the vaccine over time.

Throughout the study, participants will be observed for any side effects or reactions to the vaccine. The study aims to ensure the vaccine is safe and to measure how well it helps the body build protection against the bacteria that cause meningococcal meningitis. This research is important for developing effective vaccines to prevent this serious disease in young people.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and first vaccination
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you are healthy and eligible to participate.
If you are a female of childbearing potential, a urine sample will be collected for a pregnancy test.
You will receive the first dose of the MenABCWY vaccine as an injection into the muscle. This is known as an intramuscular injection.
You will be asked to keep an electronic diary (eDiary) to record any reactions or side effects you experience in the 7 days following the vaccination.
Step 2
Follow-up visits and second vaccination
You will return for follow-up visits to monitor your health and any reactions to the vaccine. These visits will occur at specified intervals.
The second dose of the MenABCWY vaccine will be administered either 24 months or 48 months after the first dose, depending on the group you are assigned to.
Before the second vaccination, if applicable, another pregnancy test will be conducted for females of childbearing potential.
You will continue to use the eDiary to record any reactions or side effects for 7 days following the second vaccination.
Step 3
Ongoing monitoring and final assessments
You will be monitored for any side effects or health changes for 30 days after each vaccination.
Additional follow-up visits will be scheduled to assess your immune response to the vaccine and to ensure your safety throughout the study.
The study will conclude with a final assessment to evaluate the overall safety and effectiveness of the vaccine.

Who can join the trial?

7 criteria

The participant or their parent(s)/Legally Acceptable Representative(s) must be able to follow the study rules, like filling out electronic diaries, coming back for follow-up visits, and being available for phone calls.
Written or witnessed/thumb printed informed consent must be obtained from the participant or their parent(s)/Legally Acceptable Representative(s) before any study procedures are done.
Written informed assent must be obtained from the participant, if applicable, before any study procedures are done. Assent means the participant agrees to take part in the study.
The participant must be a male or female between 11 and 14 years old at the time of the first vaccination.
The participant must be healthy, as determined by their medical history, physical examination, and the investigator's clinical judgment before joining the study.
Female participants who cannot have children may join the study. This includes those who have not started menstruating, or have had surgery to remove the uterus, fallopian tubes, or ovaries.
Female participants who can have children may join the study if they have used effective birth control for 30 days before the first vaccination, have a negative pregnancy test on the day of vaccination, and agree to use effective birth control for 30 days before and after each of the two subsequent vaccinations. Pregnancy tests will be done using urine samples at specific visits before vaccination.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to any component of the vaccine cannot participate.
Individuals with a current or past diagnosis of **Meningitis, Meningococcal** are excluded. Meningitis is an infection that causes inflammation of the protective membranes covering the brain and spinal cord.
Participants who have received any other vaccine within 30 days prior to the study start date are not eligible.
People with a weakened immune system, which means their body has a reduced ability to fight infections, cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Individuals with any serious chronic illness that could interfere with the study results are excluded. A chronic illness is a long-lasting health condition that may not go away.
Participants who are currently taking part in another clinical trial are not eligible.
Anyone with a history of drug or alcohol abuse within the past year is excluded. Abuse refers to the harmful or hazardous use of substances.
Individuals who have had a blood transfusion or received blood products within the last 3 months cannot participate.
People with any condition that, in the opinion of the study doctor, could interfere with the study or the safety of the participant are excluded.

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Studienzentrum FMZ Radowsky
Leipzig, Germany

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Investigated drugs

MenABCWY is a vaccine designed to protect against infections caused by a bacteria called Neisseria meningitidis, which can lead to serious illnesses like meningitis. This vaccine targets multiple strains of the bacteria, including serogroup B, which is one of the most common causes of meningococcal disease. In this clinical trial, the vaccine is being tested to see how well it works when given on different schedules, and to ensure it is safe and well-tolerated by participants aged 11 to 14 years. The goal is to understand how the immune system responds to the vaccine and to monitor any side effects that might occur after vaccination.

What is already known about the treatment

MenABCWY – This medication is administered as a vaccine injection, typically given in the arm. It is currently being studied in clinical trials to determine its safety, tolerability, and ability to provoke an immune response in healthy individuals aged 11 to 14 years. The main use of MenABCWY is to protect against meningococcal meningitis, a serious infection caused by the bacteria Neisseria meningitidis. At the molecular level, the vaccine works by stimulating the body's immune system to recognize and fight off the bacteria if exposed in the future. MenABCWY falls under the pharmacological classification of vaccines, which are substances used to stimulate the production of antibodies and provide immunity against diseases.

Investigated diseases

Meningitis, Meningococcal – Meningococcal meningitis is an infection of the protective membranes covering the brain and spinal cord, known as the meninges, caused by the bacterium Neisseria meningitidis. The disease begins with the bacteria entering the bloodstream and traveling to the brain and spinal cord. It progresses rapidly, often starting with flu-like symptoms such as fever, headache, and neck stiffness. As the infection advances, it can lead to more severe symptoms like confusion, vomiting, sensitivity to light, and a distinctive rash. The inflammation caused by the infection can lead to swelling of the brain and spinal cord, which may result in neurological complications. The disease requires prompt medical attention to prevent further progression.