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Recombinant Neisseria Meningitidis Group B Nada Protein Produced In E. Coli Cells By Recombinant Dna Technology Adsorbed On Aluminium Hydroxide

This article summarizes recent clinical trials investigating the safety and immunogenicity of vaccines containing recombinant Neisseria meningitidis group B NadA protein produced in E. coli cells by recombinant DNA technology and adsorbed on aluminum hydroxide. These vaccines are being studied for prevention of meningococcal disease caused by serogroup B strains in various populations, including healthy infants, adolescents, and adults with certain medical conditions. The trials aim to evaluate immune responses, dosing schedules, and safety profiles of these novel meningococcal B vaccines.

Table of Contents

What is this vaccine?

This vaccine contains a recombinant Neisseria meningitidis group B NadA protein that is produced in E. coli cells using recombinant DNA technology. The protein is then adsorbed onto aluminum hydroxide.[1] It is part of a combination vaccine that protects against meningococcal disease caused by several serogroups of N. meningitidis bacteria.

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the NadA protein found on the surface of meningococcal group B bacteria. If a vaccinated person is later exposed to these bacteria, their immune system can quickly recognize and destroy them before they cause disease.[1]

What is it used for?

This vaccine component is used to help prevent invasive meningococcal disease caused by Neisseria meningitidis group B bacteria. Meningococcal disease can cause serious infections like meningitis (infection of the lining of the brain and spinal cord) and septicemia (blood infection).[1]

How is it administered?

The vaccine is given as an intramuscular injection, typically in the upper arm or thigh. It is usually given as a series of doses according to a specific schedule, which may vary depending on age and other factors.[1]

What do clinical trials show?

Clinical trials have evaluated the safety and effectiveness of this vaccine component in various populations:

  • A study in healthy adolescents aged 11-14 years found that the vaccine produced an immune response against group B meningococcal strains.[1]
  • Another trial examined its use in infants as young as 2 months old, showing it could induce antibodies against multiple group B strains.[2]
  • Research has also looked at its effectiveness in adults with asplenia (absence of a functioning spleen), who are at higher risk for meningococcal disease.[3]

Is it safe?

The vaccine has been shown to have an acceptable safety profile in clinical trials. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Headache
  • Fatigue
  • Muscle or joint pain
  • Fever

Serious allergic reactions are rare but possible with any vaccine. The benefits of protection against meningococcal disease are considered to outweigh the risks for most people.[1]

Who can receive this vaccine?

This vaccine is approved for use in various age groups, typically from infants to adults. However, it may be especially recommended for certain high-risk groups, including:

  • People with certain medical conditions, like asplenia
  • Laboratory workers routinely exposed to meningococcal bacteria
  • People living in close quarters (e.g., college dormitories)
  • Travelers to areas where meningococcal disease is common

A healthcare provider can determine if this vaccine is appropriate based on individual circumstances and risk factors.[4]

Trial Aspect Details
Populations Studied Healthy infants, adolescents, adults with asplenia, adults with generalized myasthenia gravis
Vaccine Formulations MenABCWY, Bexsero, Trumenba, combination strategies
Primary Outcomes Immunogenicity (hSBA titers), safety and tolerability
Secondary Outcomes Persistence of antibodies, cellular immune responses, quality of life measures
Safety Assessments Local and systemic reactions, adverse events, serious adverse events
Dosing Schedules Various multi-dose regimens over periods of months to years
Special Considerations Vaccination against other meningococcal serogroups, pneumococcal and Haemophilus influenzae type b

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to assess the safety, tolerability, and immunogenicity of meningococcal B vaccines containing recombinant NadA protein in different populations and dosing schedules.
  • Who are the target populations for these vaccine trials? The trials involve various populations, including healthy infants and adolescents, as well as adults with conditions like asplenia or generalized myasthenia gravis.
  • How is the immune response measured in these trials? Immune response is typically measured using human serum bactericidal antibody (hSBA) assays, which assess the ability of antibodies to kill meningococcal bacteria.
  • What are some of the safety assessments conducted? Safety assessments include monitoring for adverse events, both local (at injection site) and systemic, as well as any serious adverse events or adverse events of special interest.
  • Why are different dosing schedules being evaluated? Different dosing schedules are being studied to determine the optimal timing and number of doses needed to achieve protective immunity while minimizing the number of injections required.

Ongoing Clinical Trials on Recombinant Neisseria Meningitidis Group B Nada Protein Produced In E. Coli Cells By Recombinant Dna Technology Adsorbed On Aluminium Hydroxide

  • A study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease

    Recruiting

    2 1 1 1
    Investigated drugs:
    Italy Spain

  • A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

    Recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Italy Poland Spain

  • Study on Immune Response Differences to Meningococcal Group B Vaccine in Healthy Transgender and Cisgender Adults Aged 18-40

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium

  • Study of rMenB+OMV NZ meningococcal group B vaccine immune response and safety in previously vaccinated healthy participants aged 10 to 20 years

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland Italy 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 Meningococcal B Vaccine in Adults Without a Spleen

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Austria

  • Study on the Safety and Immune Response of MenABCWY Vaccine in Healthy Adolescents Aged 11-14 with Meningococcal Meningitis

    Not recruiting

    2 1
    Investigated drugs:
    Germany

  • 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 Safety and Immune Response of Meningococcal B Vaccines in Adults with Asplenia: Bexsero, Trumenba, and a Drug Combination

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Recombinant NadA protein: A protein from Neisseria meningitidis group B that is produced using genetic engineering techniques in E. coli bacteria and used as a vaccine component.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • hSBA (human serum bactericidal antibody) assay: A laboratory test that measures the ability of antibodies in a person's serum to kill meningococcal bacteria, used to assess vaccine-induced immunity.
  • Seroconversion: The development of detectable antibodies in the blood directed against an infectious agent, often used to determine vaccine effectiveness.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Asplenia: The absence of a normal functioning spleen, either due to surgical removal or a medical condition.
  • Generalized Myasthenia Gravis (gMG): An autoimmune neuromuscular disorder characterized by muscle weakness and fatigue.
  • Aluminium hydroxide: A substance used as an adjuvant in vaccines to enhance the immune response to the vaccine components.
  • Meningococcal disease: A serious bacterial infection caused by Neisseria meningitidis that can lead to meningitis and septicemia.
  • Phase II/III clinical trial: Stages of clinical research that assess the efficacy and safety of a new treatment in larger groups of people, comparing it to standard treatments or placebos.

References

  1. http://clinicaltrials.eu/trial-id/2023-504301-37-00
  2. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  3. http://clinicaltrials.eu/trial-id/2023-508192-36-00
  4. http://clinicaltrials.eu/trial-id/2024-513649-35-00