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Neisseria Meningitidis, Serogroup C, Polysaccharide, Conjugated To Tetanus Toxoid

Clinical trials are currently underway to evaluate the effectiveness and safety of a quadrivalent meningococcal conjugate vaccine containing Neisseria Meningitidis Serogroup C polysaccharide conjugated to tetanus toxoid. These studies aim to improve protection against meningococcal disease, particularly in infants and young children. The trials are comparing the new vaccine to existing vaccines and assessing immune responses, safety profiles, and dosing schedules to optimize vaccination strategies.

Table of Contents

What is NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, CONJUGATED TO TETANUS TOXOID?

NEISSERIA MENINGITIDIS, SEROGROUP C, POLYSACCHARIDE, CONJUGATED TO TETANUS TOXOID is a component of a vaccine known as MenQuadfi. This vaccine is designed to protect against meningococcal infections caused by specific groups of bacteria[1]. To understand this better, let’s break down the name:

  • Neisseria meningitidis: This is the bacterium that causes meningococcal disease, a serious infection that can lead to meningitis (inflammation of the membranes surrounding the brain and spinal cord) and septicemia (blood poisoning).
  • Serogroup C: This refers to one specific type of Neisseria meningitidis. There are multiple serogroups, and C is one of the common ones that cause disease.
  • Polysaccharide: This is a sugar molecule from the outer coating of the bacterium, which helps trigger an immune response.
  • Conjugated to tetanus toxoid: The polysaccharide is attached (conjugated) to a harmless form of the tetanus toxin. This combination helps to enhance the immune response, especially in young children.

What does it treat?

This vaccine component is part of a quadrivalent vaccine that protects against four serogroups of Neisseria meningitidis: A, C, W, and Y[1]. Specifically, it helps prevent meningococcal infections, which can cause:

  • Meningitis: An infection of the lining of the brain and spinal cord
  • Septicemia: A serious blood infection
  • Other invasive diseases caused by these bacteria

Meningococcal infections can be life-threatening and may lead to severe complications if not treated promptly. Vaccination is an essential preventive measure, especially for individuals at higher risk of exposure or severe outcomes.

How is it administered?

The vaccine containing this component is administered as an intramuscular injection, typically in the upper arm or thigh[1]. The dosing schedule may vary depending on the age of the recipient and the specific vaccination program. In the clinical trial described, the vaccine was administered in a 1+1 schedule:

  • First dose: Given to infants at 6-7 months of age
  • Second dose (booster): Administered to toddlers at 12-13 months of age

The total volume of each dose is typically 0.5 ml[1].

Clinical Trials and Research

A Phase 3 clinical trial is being conducted to investigate the immunogenicity (ability to provoke an immune response) and safety of this vaccine compared to another meningococcal vaccine called Nimenrix®[1]. The study aims to:

  • Demonstrate that the immune response to this vaccine is not inferior to Nimenrix®
  • Compare the protection levels against meningococcal serogroups A, C, W, and Y
  • Describe the antibody response before and after vaccination
  • Evaluate the safety profile of the vaccine

The trial involves healthy infants and toddlers, with vaccinations given at 6-7 months and 12-13 months of age[1].

Who can receive this vaccine?

Based on the clinical trial information, this vaccine is being studied in healthy infants and toddlers. However, there are specific inclusion and exclusion criteria[1]:

Inclusion criteria:

  • Aged 6 to 7 months at the time of inclusion
  • Healthy as determined by medical evaluation

Exclusion criteria:

  • Known or suspected immunodeficiency
  • History of meningococcal infection
  • High risk for meningococcal infection (e.g., complement deficiency, asplenia)
  • History of Guillain-Barré syndrome or severe reactions to vaccines
  • Recent receipt of other vaccines

Safety Profile

The clinical trial is designed to assess the safety of the vaccine. Researchers will monitor for[1]:

  • Immediate adverse events
  • Injection site reactions
  • Systemic reactions
  • Unsolicited adverse events
  • Serious adverse events

It’s important to note that all vaccines undergo rigorous safety testing before approval for general use.

Importance of Vaccination

Vaccination against meningococcal disease is crucial because:

  • Meningococcal infections can be life-threatening and progress rapidly
  • Early symptoms can be similar to other illnesses, making quick diagnosis challenging
  • Prevention through vaccination is more effective than treating the disease after infection
  • It helps protect not only individuals but also contributes to community immunity

By studying and developing vaccines like this one, researchers aim to provide better protection against meningococcal disease, particularly for young children who are at higher risk of severe outcomes[1].

Aspect Details
Vaccine Type Quadrivalent meningococcal conjugate vaccine (MenACYW)
Target Serogroups A, C, W, and Y
Study Population Healthy infants and toddlers
Vaccination Schedule 1+1 (6-7 months and 12-13 months)
Primary Objective Demonstrate non-inferiority of antibody response compared to existing vaccine
Key Measurements Antibody titers, seroprotection rates, safety profile
Safety Monitoring Adverse events, injection site reactions, systemic reactions
Comparison MenACYW conjugate vaccine vs. Nimenrix®

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the immunogenicity (ability to produce an immune response) and safety of a new quadrivalent meningococcal conjugate vaccine compared to existing vaccines. The trials aim to demonstrate that the new vaccine is at least as effective as current vaccines in protecting against meningococcal serogroups A, C, W, and Y.
  • Who are the participants in these trials? The trials involve healthy infants and toddlers. One study specifically focuses on children aged 6-7 months for the first dose and 12-13 months for the second dose. The goal is to assess the vaccine's effectiveness and safety in young children, who are at higher risk for meningococcal disease.
  • What is the vaccination schedule being studied? The trials are investigating a '1+1' schedule, which means administering two doses of the vaccine. The first dose is given to infants at 6-7 months of age, and the second (booster) dose is given to toddlers at 12-13 months of age. This schedule is being compared to the same schedule using an existing vaccine.
  • How is the vaccine's effectiveness measured? The vaccine's effectiveness is primarily measured by looking at the antibody response against meningococcal serogroups A, C, W, and Y. This is done by measuring geometric mean titers (GMTs) of antibodies and the percentage of participants achieving certain antibody levels considered protective. The studies also look at how long the protection lasts.
  • What safety aspects are being monitored in these trials? The trials are closely monitoring various safety aspects, including immediate adverse events, injection site reactions, systemic reactions, and any serious adverse events. Participants are observed after vaccination, and their health is monitored throughout the study period to ensure the vaccine's safety profile is well understood.

Ongoing Clinical Trials on Neisseria Meningitidis, Serogroup C, Polysaccharide, Conjugated To Tetanus Toxoid

  • Safety and immunogenicity study of Pentavalent Meningococcal ABCYW vaccine (MenPenta SD and MenPenta fHD) compared to licensed meningococcal vaccines in infants, toddlers and children

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Czechia Denmark Finland Germany Poland Spain

  • Study on the Safety and Immune Response of MenACYW Conjugate Vaccine Compared to a Drug Combination in Healthy Infants and Toddlers

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Finland Germany Poland Romania

  • Study on the Effectiveness and Safety of Danicopan for Adults with Chronic Spontaneous Urticaria Resistant to H1-Antihistamines

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Meningococcal disease: A serious bacterial infection caused by Neisseria meningitidis that can lead to meningitis (inflammation of the protective membranes covering the brain and spinal cord) and septicemia (blood poisoning). It can be life-threatening and requires immediate medical attention.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (a substance that prompts an immune response) with a strong antigen to create a more powerful immune response. In this case, the meningococcal polysaccharides are conjugated (linked) to tetanus toxoid to enhance the vaccine's effectiveness.
  • Serogroups: Distinct variations within a species of bacteria. For Neisseria meningitidis, the main disease-causing serogroups are A, B, C, W, and Y. The vaccine in these trials targets serogroups A, C, W, and Y.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body. In these trials, immunogenicity is measured by the production of antibodies against meningococcal serogroups.
  • Geometric Mean Titers (GMTs): A way of measuring the average concentration of antibodies in the blood. It's calculated by multiplying all the individual antibody levels and then taking the nth root of the product, where n is the number of individuals.
  • Seroprotection: The state of having sufficient antibodies in the blood to protect against a specific disease. In these trials, seroprotection is assessed by measuring the percentage of participants who achieve certain predefined antibody levels.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the study, whether or not it is related to the vaccine. These are carefully monitored to assess the safety of the vaccine.
  • Booster dose: An additional dose of a vaccine given after the initial dose(s) to 'boost' the immune response and provide longer-lasting protection. In these trials, the booster dose is given at 12-13 months of age.

References

  1. http://clinicaltrials.eu/trial-id/2023-508177-85-00