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Neisseria Meningitidis Group Y Polysaccharide Conjugated To Tetanus Toxoid Carrier Protein

This article summarizes clinical trials investigating the use of a vaccine containing Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein. This vaccine is being studied to prevent meningococcal disease caused by serogroup Y, often as part of combination vaccines also targeting other meningococcal serogroups. The trials examine the safety, tolerability, and immune responses in various age groups, from infants to adults.

Table of Contents

What is the Meningococcal Group Y Conjugate Vaccine?

The meningococcal group Y conjugate vaccine is a component of broader meningococcal vaccines designed to protect against Neisseria meningitidis, a bacterium that can cause serious infections like meningitis and septicemia. This specific component targets the Y serogroup of N. meningitidis.[1]

The vaccine contains Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein. This means that part of the bacteria’s outer coating (the polysaccharide) is attached to a harmless protein from the tetanus toxin. This combination helps stimulate a stronger immune response than the polysaccharide alone would.[2]

How Does It Work?

When administered, the vaccine stimulates the body’s immune system to produce antibodies against the Y serogroup of N. meningitidis. These antibodies can then recognize and fight off the bacteria if a person is exposed to it in the future, potentially preventing infection or reducing its severity.[3]

The conjugation to tetanus toxoid helps make the vaccine more effective, especially in young children. It transforms the immune response from T-cell independent to T-cell dependent, leading to a more robust and longer-lasting immunity.[2]

Who Is It For?

The meningococcal group Y conjugate vaccine is typically part of broader meningococcal vaccines that protect against multiple serogroups (usually A, C, W, and Y). These vaccines are recommended for:

  • Infants and young children, often given in a series of doses starting as early as 2 months of age[4]
  • Adolescents and young adults, particularly those entering college or military service
  • People with certain medical conditions that increase their risk of meningococcal disease
  • Travelers to areas where meningococcal disease is more common
  • Laboratory workers who routinely work with N. meningitidis

How Is It Administered?

The vaccine is typically given as an intramuscular injection. The specific schedule can vary depending on the age at which vaccination starts and the particular vaccine formulation used. For example:

  • Infants might receive doses at 2, 4, 6, and 12 months of age[4]
  • Older children, adolescents, and adults usually receive one or two doses
  • Booster doses may be recommended for people at ongoing risk

How Effective Is It?

Clinical trials have shown that meningococcal conjugate vaccines containing the group Y component are highly effective at stimulating an immune response. For example:

  • In infants, over 90% achieved protective antibody levels against serogroup Y after completing the vaccination series[4]
  • In older children and adults, a single dose often results in protective antibody levels in over 95% of recipients

However, it’s important to note that while the vaccine is very effective, it doesn’t provide 100% protection and immunity can wane over time.

Is It Safe?

Meningococcal conjugate vaccines, including those with the group Y component, have been shown to have a good safety profile. Common side effects are generally mild and may include:[5]

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Fever
  • Irritability in young children

Serious side effects are rare but can include severe allergic reactions. As with any vaccine, healthcare providers carefully monitor for any adverse events.

Ongoing Research

Several clinical trials are currently underway to further study meningococcal vaccines containing the group Y component. These studies aim to:

  • Assess long-term immunity and the potential need for booster doses[6]
  • Evaluate the vaccine’s effectiveness in different age groups and populations
  • Study new combination vaccines that might provide broader protection
  • Investigate alternative dosing schedules to optimize protection and practicality

This ongoing research helps ensure that vaccination strategies continue to provide the best possible protection against meningococcal disease.

Trial Aspect Details
Study Types Phase 1, Phase 2, and Phase 3 clinical trials
Age Groups Infants (5 months+), children, adolescents, and adults
Vaccine Formulations Various combinations including MenACWY, MenABCWY, and comparisons with other meningococcal vaccines
Primary Outcomes Safety, tolerability, immunogenicity
Secondary Outcomes Antibody persistence, booster responses, comparison with other vaccines
Safety Monitoring Adverse events, serious adverse events, solicited and unsolicited reactions
Immunogenicity Measures Serum bactericidal assay (hSBA) titers, geometric mean titers (GMTs), seroprotection rates
Study Designs Randomized, controlled, observer-blind, open-label extensions
Dosing Schedules Various, including primary series and booster doses
Follow-up Periods Range from several months to multiple years for long-term studies

FAQ

  • What is the purpose of this vaccine? The vaccine containing Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein is designed to prevent meningococcal disease caused by serogroup Y. It is often studied as part of combination vaccines that also target other meningococcal serogroups like A, C, and W.
  • What age groups are being studied in these clinical trials? The clinical trials are studying the vaccine in various age groups, ranging from infants as young as 5 months old to adults. Some studies focus specifically on children and adolescents, while others include adult participants.
  • What are the main outcomes being measured in these trials? The main outcomes being measured include safety and tolerability of the vaccine, immune responses (such as antibody levels against meningococcal serogroups), and in some cases, the effectiveness of different dosing schedules or comparison to other meningococcal vaccines.
  • Are there any specific safety concerns being monitored? While the trials monitor for all adverse events, some specific safety concerns being watched include injection site reactions, systemic reactions, and any serious adverse events. Long-term safety follow-up is also included in some studies.
  • How is the vaccine administered in these trials? The vaccine is typically administered via intramuscular injection. Some trials investigate different dosing schedules, such as primary vaccination series followed by booster doses at various intervals.

Ongoing Clinical Trials on Neisseria Meningitidis Group Y Polysaccharide Conjugated To Tetanus Toxoid Carrier Protein

  • Study on Early Measles Immunization with MMR-0 Vaccine for Infants Under 12 Months During a Measles Outbreak

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of a Booster Dose of MenACYW Conjugate Vaccine in Children and Adolescents Previously Vaccinated for Meningococcal Infection

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Finland Germany Hungary Spain

  • Study on the Safety and Immune Response of MenABCWY Vaccine and Drug Combination in Healthy Infants with Meningococcal Infections

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany Poland Spain

  • 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 mRNA-1345 and mRNA-1365 for Infants with Acute Lower Respiratory Infection Aged 5 to 24 Months

    Not recruiting

    1 1 1
    Investigated drugs:
    Latvia Poland Spain

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

    Not recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • 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 Safety and Tolerability of DNTH103 for Adults with Generalized Myasthenia Gravis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Italy The Netherlands Norway +3

  • 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

  • Study on Long-term Safety and Efficacy of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +2

Glossary

  • Neisseria meningitidis: A bacterium that can cause severe infections, including meningitis (inflammation of the membranes covering the brain and spinal cord) and septicemia (blood infection). It is classified into different serogroups, including A, B, C, W, and Y.
  • Serogroup: A group of bacteria that share common surface structures. In the context of Neisseria meningitidis, serogroups are defined by the chemical composition of the bacterial capsule.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a strong antigen to enhance the immune response. In this case, the meningococcal polysaccharide is conjugated to tetanus toxoid.
  • Tetanus toxoid: An inactivated form of the tetanus toxin, used as a carrier protein in conjugate vaccines to improve the immune response, especially in young children.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization or extension of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
  • Geometric mean titer (GMT): A measure of the average antibody level in a group of subjects, calculated using the geometric mean of individual antibody titers.
  • Seroprotection: The development of a sufficient level of antibodies to protect against a specific disease, typically defined as antibody titers above a certain threshold.
  • Open-label study: A type of clinical trial in which both the researchers and participants know which treatment is being administered.
  • Randomized controlled trial (RCT): A study design where participants are randomly assigned to receive either the investigational treatment or a control (such as a placebo or standard treatment).
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body, including their mechanisms of action and relationship between drug concentration and effect.

References

  1. http://clinicaltrials.eu/trial-id/2022-502022-41-00
  2. http://clinicaltrials.eu/trial-id/2023-504625-39-00
  3. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  4. http://clinicaltrials.eu/trial-id/2023-508177-85-00
  5. http://clinicaltrials.eu/trial-id/2023-510145-25-00
  6. http://clinicaltrials.eu/trial-id/2024-512386-14-00