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N. Meningitidis Group C (Strain C11) Polysaccharide (De-O-Acetylated) Conjugated To Tetanus Toxoid

This article summarizes several clinical trials investigating the safety, tolerability, and efficacy of vaccines containing N. Meningitidis Group C polysaccharide conjugated to tetanus toxoid. These vaccines aim to prevent meningococcal disease caused by serogroup C and other meningococcal serogroups. The trials examine the vaccines’ use in various age groups, from infants to adults, and evaluate immune responses, dosing schedules, and potential side effects.

Table of Contents

What is the Meningococcal Group C Conjugate Vaccine?

The Meningococcal Group C Conjugate Vaccine, also known as N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID, is a vaccine designed to prevent infections caused by the Neisseria meningitidis bacteria, specifically serogroup C[1]. This vaccine is part of a larger group of meningococcal vaccines that protect against various strains of the bacteria.

The vaccine contains a part of the outer coating of the Neisseria meningitidis group C bacteria, which has been chemically linked (conjugated) to a tetanus toxoid protein. This conjugation helps to enhance the immune response, especially in young children[1].

How Does the Vaccine Work?

When the vaccine is administered, it stimulates the body’s immune system to produce antibodies against the Neisseria meningitidis group C bacteria. These antibodies help protect the body if it encounters the actual bacteria in the future[1].

The conjugation to tetanus toxoid is a crucial aspect of the vaccine’s design. It helps to create a stronger and longer-lasting immune response, particularly in infants and young children whose immune systems are still developing[1].

Who Should Get Vaccinated?

The Meningococcal Group C Conjugate Vaccine is typically recommended for:

  • Infants and young children as part of routine vaccination schedules
  • Adolescents and young adults, especially 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

The specific recommendations may vary by country and individual circumstances. It’s important to consult with a healthcare provider to determine if and when vaccination is appropriate[2].

Effectiveness of the Vaccine

Studies have shown that the Meningococcal Group C Conjugate Vaccine is highly effective in preventing invasive meningococcal disease caused by serogroup C. The vaccine has been found to induce a strong immune response, with high levels of protective antibodies observed in most recipients[2].

Research indicates that the vaccine’s effectiveness can last for several years, although the duration of protection may vary depending on the age at which the vaccine is administered. Booster doses may be recommended in some cases to maintain long-term protection[2].

Safety and Side Effects

The Meningococcal Group C Conjugate Vaccine has been shown to have a good safety profile. Like all vaccines, it can cause some side effects, but serious reactions are rare[2].

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 notice any severe or unusual symptoms after vaccination, seek medical attention immediately[2].

How is the Vaccine Administered?

The Meningococcal Group C Conjugate Vaccine is typically given as an intramuscular injection, usually in the thigh for infants or the upper arm for older children and adults. The number of doses and schedule can vary depending on the specific vaccine product and the age at which vaccination begins[3].

For example, infants may receive multiple doses as part of their primary vaccination series, while older children or adults may only need a single dose. Booster doses may be recommended for certain age groups or high-risk individuals[3].

Ongoing Research

Researchers continue to study the Meningococcal Group C Conjugate Vaccine to better understand its long-term effectiveness, optimal dosing schedules, and potential use in different populations. Some current areas of research include:

  • Evaluating the vaccine’s effectiveness when given at different ages
  • Studying the duration of protection and the need for booster doses
  • Investigating the vaccine’s impact on meningococcal carriage and herd immunity
  • Developing combination vaccines that protect against multiple meningococcal serogroups

These ongoing studies help to ensure that vaccination strategies remain effective and can be optimized to provide the best protection against meningococcal disease[4].

Trial Aspect Details
Vaccine Components N. Meningitidis Group C polysaccharide conjugated to tetanus toxoid, often combined with other serogroups (A, W, Y)
Age Groups Infants (5-24 months), children, adolescents, adults (up to 75 years)
Primary Objectives Safety, tolerability, immunogenicity assessment
Secondary Objectives Antibody persistence, booster response, comparison with other vaccines
Study Designs Randomized controlled trials, open-label studies, extension studies
Outcome Measures Serum bactericidal antibody titers, geometric mean titers, adverse events
Safety Monitoring Local and systemic reactions, serious adverse events, long-term follow-up
Dosing Schedules Various, including single doses, primary series, and booster doses
Follow-up Duration Ranging from several months to over a year
Special Populations Some trials include participants with specific health conditions or vaccination histories

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, tolerability, and effectiveness of vaccines containing N. Meningitidis Group C polysaccharide conjugated to tetanus toxoid in preventing meningococcal disease. The trials aim to determine appropriate dosing schedules, assess immune responses in different age groups, and monitor for any potential side effects.
  • What age groups are being studied in these trials? The clinical trials cover a wide range of age groups, from infants as young as 5 months old to adults. Some studies focus specifically on infants and toddlers, while others include children, adolescents, and adults up to 75 years of age.
  • How is the vaccine's effectiveness measured? The vaccine's effectiveness is primarily measured by assessing the immune response it generates. This is done by measuring antibody levels in the blood, specifically looking at serum bactericidal antibody titers against various meningococcal serogroups. Some trials also evaluate the persistence of these antibodies over time.
  • Are there any side effects associated with these vaccines? The trials monitor for potential side effects, which can include local reactions at the injection site (such as pain, redness, or swelling) and systemic reactions (such as fever or fatigue). Serious adverse events are also closely monitored. However, the specific side effects observed in each trial may vary and are carefully documented as part of the safety evaluation.
  • How long do these clinical trials typically last? The duration of these clinical trials varies, but many include long-term follow-up periods to assess the persistence of immune responses and long-term safety. Some trials last for several months, while others may follow participants for up to 52 weeks or even longer in extension studies.

Ongoing Clinical Trials on N. Meningitidis Group C (Strain C11) Polysaccharide (De-O-Acetylated) Conjugated To Tetanus Toxoid

  • 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 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

  • N. Meningitidis: Neisseria meningitidis, a bacterium that can cause severe infections including meningitis and septicemia. It is classified into different serogroups, with groups A, B, C, W, and Y being the most common causes of disease.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (in this case, bacterial polysaccharides) with a strong antigen (such as tetanus toxoid) to elicit a stronger immune response, especially in young children.
  • Serogroup: A group of bacteria that share common surface structures. In the context of N. meningitidis, different serogroups (like A, B, C, W, and Y) are distinguished by their capsular polysaccharides.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Serum bactericidal antibody (SBA): Antibodies in the blood that can kill bacteria. Measuring SBA levels is a way to assess the effectiveness of meningococcal vaccines.
  • Geometric mean titer (GMT): A type of average used to measure antibody levels in a group of individuals. It is calculated by multiplying all the values and then taking the nth root of the product, where n is the number of values.
  • Adverse event (AE): Any unfavorable and 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.
  • 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 that randomly assigns participants into an experimental group or a control group to minimize bias.
  • Booster dose: An additional dose of a vaccine given after the initial series to 'boost' the immune response and extend the duration of protection.

References

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