Study on Immune Response to Meningococcal Vaccine in Elderly with Invasive Meningococcal Disease Using MenACWY-TT Conjugate Vaccine

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What is this study about?

This clinical trial is focused on studying the effects of a vaccine called Nimenrix on older adults. The vaccine is designed to protect against a serious illness known as invasive meningococcal disease, which can lead to conditions like sepsis and meningitis. These conditions are caused by a type of bacteria called Neisseria meningitidis, which can be life-threatening. The vaccine targets four groups of this bacteria: A, C, W-135, and Y, and is given as an injection.

The purpose of the study is to investigate how well the immune system of older adults responds to the vaccine. Participants will receive the vaccine and then have their blood tested to measure the levels of protective antibodies, which are proteins the body makes to fight infections. The study will also look at how these antibody levels change over time, both shortly after vaccination and up to five years later. This will help researchers understand how long the vaccine’s protection lasts.

Participants in the study will be older adults between the ages of 65 and 85 who have not previously received the MenACWY-TT vaccine. The study will involve receiving the vaccine and then having follow-up visits to monitor the immune response. The goal is to gather information that could help improve vaccination strategies for older adults, ensuring they are better protected against these serious infections.

1 initial vaccination

Upon joining the study, the participant will receive an injection of the Nimenrix vaccine. This vaccine is designed to protect against four types of meningococcal bacteria: A, C, W-135, and Y.

The vaccine is administered as a solution for injection into the muscle, a method known as intramuscular injection.

2 first follow-up

One month after the initial vaccination, the participant will return for a follow-up visit.

During this visit, blood samples will be taken to measure the levels of antibodies in the blood. Antibodies are proteins that help fight infections.

3 second follow-up

One year after the initial vaccination, the participant will have another follow-up visit.

Blood samples will again be collected to assess the persistence of antibody levels over time.

4 booster vaccination

Participants may receive a booster dose of the vaccine. A booster dose is an additional dose given after the initial vaccination to help maintain immunity.

The timing of the booster dose will be determined based on the study’s schedule.

5 third follow-up

One month after receiving the booster vaccination, participants will return for another follow-up visit.

Blood samples will be taken to measure antibody levels and assess the response to the booster dose.

6 fourth follow-up

One year after the booster vaccination, participants will have a final follow-up visit.

This visit will include blood sample collection to evaluate long-term antibody levels.

7 long-term follow-up

Five years after the initial vaccination, participants will be asked to return for a long-term follow-up visit.

This visit will involve collecting blood samples to determine the persistence of antibodies over an extended period.

Who Can Join the Study?

Participants must be between 65 and 85 years old.
Participants should be in moderate to good general health for their age.
Participants must not have received a MenACWY-TT vaccine before. This is a vaccine that protects against certain types of meningococcal bacteria.

Who Cannot Join the Study?

Patients with a history of invasive meningococcal disease cannot participate. This includes diseases like sepsis (a severe infection that spreads throughout the body) and meningitis (an infection of the protective membranes covering the brain and spinal cord).
Patients who have received any vaccine against MenA, MenC, MenW, or MenY in the past cannot participate. These are types of bacteria that can cause serious infections.
Patients with any known allergies to the components of the study vaccine cannot participate.
Patients with a weakened immune system, which means their body has a reduced ability to fight infections, cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with any serious chronic illness that could interfere with the study cannot participate. A chronic illness is a long-lasting health condition that may not go away.
Patients who have had a blood transfusion or received blood products in the last 3 months cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)	Bilthoven	The Netherlands

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	13.06.2022

Trial locations

Investigated drugs:

The study involves the use of the MenACWY-TT conjugate vaccine. This vaccine is designed to protect against four types of bacteria that can cause meningococcal disease, which is a serious infection that can lead to conditions like meningitis. The vaccine works by helping the body build up its defense system, known as the immune system, to fight off these bacteria if they are encountered in the future. In this trial, the vaccine is being tested in elderly people to see how well it helps their bodies produce protective antibodies, which are proteins that can neutralize harmful bacteria and prevent illness.

Invasive Meningococcal Disease – This disease is caused by the bacterium Neisseria meningitidis, which can invade the body and lead to serious infections. It often begins with flu-like symptoms such as fever, headache, and stiff neck. As it progresses, it can cause severe complications like meningitis, which is the inflammation of the protective membranes covering the brain and spinal cord. The disease can also lead to sepsis, a life-threatening response to infection that can cause tissue damage and organ failure. Invasive meningococcal disease can spread rapidly and requires immediate medical attention to prevent severe outcomes. It is transmitted through respiratory droplets from an infected person.

Trial ID:

2024-513640-29-00

Protocol code:

IIV-407

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Immune Response to Meningococcal Vaccine in Elderly with Invasive Meningococcal Disease Using MenACWY-TT Conjugate Vaccine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?