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Neisseria Meningitidis Group W-135 Polysaccharide Conjugated To Tetanus Toxoid Carrier Protein

This article summarizes clinical trials investigating the use of Neisseria Meningitidis Group W-135 Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein vaccine. This vaccine is designed to prevent meningococcal disease caused by serogroup W-135. The trials examine the safety, tolerability, and immune responses in various age groups, from infants to adults. The studies aim to determine optimal dosing schedules and evaluate the vaccine’s effectiveness when given alone or in combination with other meningococcal vaccines.

Table of Contents

What is the Meningococcal Group W-135 Conjugate Vaccine?

The Meningococcal Group W-135 Conjugate Vaccine is a vaccine that helps protect against invasive meningococcal disease caused by the bacteria Neisseria meningitidis serogroup W-135. This vaccine contains polysaccharides (sugar molecules) from the outer coating of the W-135 bacteria that are chemically linked (conjugated) to a carrier protein called tetanus toxoid.[1]

The vaccine is known by several names, including:

  • NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
  • Meningococcal group W-135 conjugate vaccine
  • MenW-TT

It is often included as part of combination vaccines that protect against multiple meningococcal serogroups, such as the quadrivalent ACWY vaccines.[2]

How Does the Vaccine Work?

The vaccine works by stimulating the body’s immune system to produce antibodies against the W-135 serogroup of N. meningitidis bacteria. The polysaccharides from the bacterial coating trigger an immune response, while the tetanus toxoid carrier protein helps enhance this response, especially in young children.[3]

When vaccinated individuals are later exposed to W-135 meningococcal bacteria, their immune system can quickly recognize and fight off the infection before it causes serious disease.

Who Should Get Vaccinated?

The meningococcal W-135 conjugate vaccine is recommended for several groups:

  • Infants and young children, typically starting at 2 months of age[4]
  • Adolescents and young adults
  • People traveling to areas where meningococcal disease is common
  • People with certain medical conditions that increase risk of meningococcal disease
  • Laboratory workers routinely exposed to N. meningitidis

The exact vaccination schedule may vary depending on the specific vaccine product and local recommendations. Always consult with a healthcare provider to determine if this vaccine is appropriate for you or your child.

How is the Vaccine Administered?

The meningococcal W-135 conjugate vaccine is typically given as an intramuscular injection, usually in the thigh for infants or the upper arm for older children and adults. It may be given as a single dose or as part of a multi-dose series, depending on the age of the recipient and the specific vaccine product.[5]

For example, some vaccination schedules include:

  • 2 doses given at 2 and 4 months of age, with a booster at 12 months
  • A single dose for adolescents or adults
  • Additional booster doses for people at ongoing high risk

Efficacy and Immune Response

Clinical studies have shown that the meningococcal W-135 conjugate vaccine is highly effective at stimulating a protective immune response. After vaccination, a high percentage of recipients develop antibodies against the W-135 serogroup at levels considered protective.[2]

The conjugate vaccine technology used in this vaccine helps produce a stronger and longer-lasting immune response compared to older polysaccharide vaccines, especially in young children. This leads to better protection and the potential for longer-lasting immunity.[3]

Safety and Side Effects

The meningococcal W-135 conjugate vaccine has been shown to have a good safety profile in clinical trials. Like all vaccines, it can cause some side effects, but serious reactions are rare.[5]

Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability in infants
  • Headache or fatigue in older children and adults

These side effects are usually mild and resolve on their own within a few days. Severe allergic reactions are very rare but can occur with any vaccine. If you experience any concerning symptoms after vaccination, contact your healthcare provider promptly.

Ongoing Research

Researchers continue to study meningococcal vaccines to improve their effectiveness and expand their use. Some areas of ongoing research include:

  • Evaluating long-term protection and the need for booster doses[4]
  • Studying the vaccine’s effectiveness in different age groups and populations
  • Investigating the potential for broader protection against multiple meningococcal serogroups
  • Assessing the impact of vaccination programs on meningococcal disease rates

These studies help ensure that vaccination strategies remain effective and can be optimized to provide the best protection against meningococcal disease.

Trial Aspect Details
Vaccine Types Neisseria Meningitidis Group W-135 Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein, often combined with other serogroups (A, C, Y)
Age Groups Infants (as young as 5 months), toddlers, children, adolescents, and adults
Administration Intramuscular injection, various dosing schedules (primary series + boosters)
Primary Outcomes Safety, tolerability, immunogenicity (antibody responses)
Secondary Outcomes Persistence of immune response, effectiveness of booster doses, comparison with other vaccines
Study Designs Randomized controlled trials, open-label studies, age de-escalation studies
Combination Vaccines MenACWY conjugate vaccines, investigational formulations (e.g., MenABCWY)
Follow-up Periods Vary by study, some extending to 5-10 years post-vaccination
Safety Monitoring Adverse events, serious adverse events, solicited and unsolicited reactions
Immunogenicity Measures Serum bactericidal antibody titers, geometric mean titers, seroresponse rates

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, tolerability, and immune responses produced by the Neisseria Meningitidis Group W-135 vaccine in different age groups, from infants to adults. The trials also aim to determine optimal dosing schedules and assess the vaccine's effectiveness when given alone or combined with other meningococcal vaccines.
  • 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. Different studies focus on specific age ranges to determine the most appropriate vaccination strategies for each group.
  • 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 doses followed by booster doses at various intervals.
  • What are some of the key outcomes being measured? Key outcomes include safety measures like adverse events, tolerability, and immunogenicity measures such as antibody levels against meningococcal serogroups. Some trials also assess the persistence of immune responses over time and the effect of booster doses.
  • Are there any combination vaccines being studied? Yes, some trials are investigating combination vaccines that include protection against multiple meningococcal serogroups (A, C, W, and Y) in a single formulation. These studies aim to provide broader protection against meningococcal disease with fewer injections.

Ongoing Clinical Trials on Neisseria Meningitidis Group W-135 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

  • Meningococcal disease: A serious bacterial infection caused by Neisseria meningitidis that can lead to meningitis (inflammation of the membranes surrounding the brain and spinal cord) and septicemia (blood poisoning).
  • Serogroup: A group of bacteria that share common antigens on their cell surface. In the context of meningococcal disease, different serogroups (like A, C, W, and Y) require specific vaccines for protection.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a bacterial polysaccharide) with a strong antigen (like a protein) to enhance 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.
  • Booster dose: An additional dose of a vaccine given after the initial series to enhance or prolong the immune response.
  • Adverse event: Any unfavorable or unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Intramuscular injection: A technique of administering a substance deep into the muscles, allowing for slower absorption compared to other routes.
  • Antibody titer: A measurement of the amount or concentration of antibodies in the blood, used to determine the strength of the immune response to a specific antigen.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the effects of the investigational drug or vaccine.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.

References

  1. http://clinicaltrials.eu/trial-id/2022-502022-41-00
  2. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  3. http://clinicaltrials.eu/trial-id/2023-508177-85-00
  4. http://clinicaltrials.eu/trial-id/2023-510145-25-00
  5. http://clinicaltrials.eu/trial-id/2024-512865-15-00