#1 Clinical Trials Search in Europe

Neisseria Meningitidis Group A Polysaccharide Conjugated To Tetanus Toxoid Carrier Protein

This article summarizes clinical trials investigating the safety, tolerability, and immunogenicity of vaccines containing Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein. These vaccines aim to prevent meningococcal disease caused by serogroups A, C, W, and Y in various age groups, from infants to adults. The trials evaluate different dosing schedules, immune responses, and potential side effects to determine optimal vaccination strategies.

Table of Contents

What is NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN?

NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN is a component of several meningococcal vaccines designed to protect against meningococcal disease, particularly serogroup A. This vaccine is part of a broader group of meningococcal conjugate vaccines that typically provide protection against multiple serogroups, including A, C, W, and Y[1].

Meningococcal disease is a serious bacterial infection caused by Neisseria meningitidis. It can lead to severe conditions such as meningitis (inflammation of the membranes surrounding the brain and spinal cord) and septicemia (blood poisoning). These conditions can be life-threatening and require immediate medical attention[1].

How Does It Work?

The vaccine works by stimulating the body’s immune system to produce antibodies against the meningococcal bacteria. Specifically, it targets the polysaccharide (sugar) coating of the Neisseria meningitidis group A bacteria. By conjugating (chemically linking) this polysaccharide to a carrier protein (in this case, tetanus toxoid), the vaccine enhances the immune response, especially in young children[1].

When vaccinated, your body recognizes the polysaccharide as foreign and produces antibodies against it. If you’re later exposed to the actual bacteria, your immune system can quickly recognize and fight off the infection before it causes serious illness[1].

Clinical Trials and Research

Several clinical trials have been conducted to evaluate the safety, efficacy, and immunogenicity of vaccines containing this component. Here are some key findings from recent studies:

  • A Phase II study (MENACWY=MEN7B-003) is evaluating the safety, tolerability, and immunogenicity of a meningococcal combined ABCWY vaccine in healthy infants and toddlers. This study aims to assess the vaccine’s effectiveness when administered in a 1+1 schedule at 6 and 12 months of age[1].
  • Another Phase IIIb study (MEQ00073) is investigating the long-term safety, efficacy, and immune persistence of a meningococcal ACWY conjugate vaccine in children and adolescents. This study focuses on participants who received the vaccine 5 or 10 years earlier as toddlers[2].
  • A Phase II trial (MAGIC) is evaluating the safety, tolerability, and efficacy of a different drug (DNTH103) for adults with generalized myasthenia gravis. While not directly related to the meningococcal vaccine, this study includes the requirement for participants to be vaccinated against encapsulated bacterial pathogens, including N. meningitidis, highlighting the importance of meningococcal vaccination in certain patient populations[3].

Safety Profile

Clinical trials have shown that meningococcal conjugate vaccines containing this component generally have a good safety profile. Common side effects may include:

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

Serious allergic reactions are rare but possible. It’s important to discuss any concerns or pre-existing medical conditions with your healthcare provider before receiving the vaccine[1].

Administration and Dosage

The vaccine is typically administered as an intramuscular injection. The dosage and schedule can vary depending on the specific vaccine formulation and the age of the recipient. For example:

  • In the MENACWY=MEN7B-003 study, the vaccine is being administered in a 1+1 schedule at 6 and 12 months of age[1].
  • Other schedules may involve multiple doses over several months or years, with potential booster doses for continued protection.

Always follow the vaccination schedule recommended by your healthcare provider or local health authorities.

Target Population

Meningococcal vaccines containing this component are typically recommended for:

  • Infants and young children, as part of routine vaccination schedules in many countries
  • 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 common
  • Laboratory workers who may be exposed to N. meningitidis

The specific recommendations can vary by country and individual risk factors[1].

Conclusion

NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN is a crucial component of modern meningococcal vaccines. These vaccines have significantly reduced the incidence of meningococcal disease in many parts of the world. Ongoing research continues to refine and improve these vaccines, potentially expanding their coverage and efficacy. As with any medical intervention, it’s essential to consult with healthcare professionals to determine the most appropriate vaccination strategy based on individual circumstances and local health guidelines.

Trial Aspect Details
Vaccine Components Neisseria meningitidis group A, C, W-135, and Y polysaccharides conjugated to tetanus toxoid carrier protein
Age Groups Studied Infants (5-24 months), children, adolescents, and adults
Primary Objectives Assess safety, tolerability, and immunogenicity of the vaccines
Secondary Objectives Evaluate antibody persistence, booster responses, and specific immune responses to each serogroup
Study Designs Randomized, controlled, partially blinded or open-label trials
Key Outcome Measures Antibody titers, seroprotection rates, adverse events, quality of life assessments
Safety Monitoring Solicited and unsolicited adverse events, serious adverse events, adverse events of special interest
Dosing Schedules Various, including single doses, multiple doses, and booster doses
Follow-up Periods Range from several months to over a year post-vaccination
Special Considerations Vaccination history, concomitant medications, underlying health conditions

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, tolerability, and immune responses produced by meningococcal vaccines containing Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein in different age groups.
  • What age groups are being studied in these trials? The trials involve various age groups, including infants as young as 5 months old, toddlers, children, adolescents, and adults.
  • How is the vaccine's effectiveness measured? Effectiveness is primarily measured by looking at antibody responses against meningococcal serogroups A, C, W, and Y. This is done through blood tests that measure antibody levels and functional antibody activity.
  • What are some common side effects being monitored? Common side effects being monitored include injection site reactions (like pain or swelling), systemic reactions (such as fever or fatigue), and any unexpected adverse events. The trials also look for serious adverse events and adverse events of special interest.
  • How long do these clinical trials typically last? The duration varies, but many of the trials include follow-up periods ranging from several months to over a year to assess long-term safety and persistence of immune responses.

Ongoing Clinical Trials on Neisseria Meningitidis Group A 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

  • 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 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

  • 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

  • Meningococcal disease: A serious bacterial infection caused by Neisseria meningitidis that can lead to meningitis (inflammation of the brain and spinal cord membranes) and septicemia (blood infection).
  • Serogroup: A group of bacteria that share similar surface structures. For Neisseria meningitidis, the main disease-causing serogroups are A, B, C, W, and Y.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a strong antigen 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.
  • Antibody titer: A measurement of the amount or concentration of antibodies in the blood, used to determine immune response to a vaccine.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes significant disability, or leads to a congenital anomaly/birth defect.
  • Open-label study: A type of clinical trial where 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 (placebo or standard treatment).
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the active treatment being studied.

References

  1. http://clinicaltrials.eu/trial-id/2023-508177-85-00
  2. http://clinicaltrials.eu/trial-id/2023-510145-25-00
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-dnth103-for-adults-with-generalized-myasthenia-gravis/