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

This article summarizes several clinical trials evaluating the safety, tolerability, and immunogenicity of recombinant Neisseria meningitidis group B vaccines, particularly focusing on the vaccine component containing recombinant factor H binding protein (fHbp) produced in E. coli cells and adsorbed on aluminum hydroxide. These trials are investigating the vaccine’s use in various populations, including healthy adolescents, infants, adults with asplenia, and patients with certain medical conditions. The studies aim to assess immune responses, safety profiles, and optimal dosing schedules for protection against meningococcal disease caused by serogroup B strains.

Table of Contents

What is the Meningococcal Group B Vaccine?

The meningococcal group B vaccine, also known as Bexsero, is a vaccine designed to prevent meningococcal disease caused by Neisseria meningitidis serogroup B bacteria.[1] This vaccine contains several key components:

  • Recombinant Neisseria meningitidis group B NHBA fusion protein
  • Recombinant Neisseria meningitidis group B NadA protein
  • Recombinant Neisseria meningitidis group B fHbp fusion protein
  • Outer membrane vesicles (OMV) from Neisseria meningitidis group B

These components are produced using recombinant DNA technology in E. coli cells and are adsorbed on aluminum hydroxide to enhance the immune response.[1]

How Does It Work?

The vaccine works by stimulating the body’s immune system to produce antibodies against specific proteins found on the surface of meningococcal B bacteria. When a vaccinated person is exposed to these bacteria, their immune system can quickly recognize and fight off the infection, preventing the development of meningococcal disease.[2]

Who Needs This Vaccine?

The meningococcal group B vaccine is recommended for several groups of people:

  • Adolescents and young adults (ages 16-23) who are at increased risk of meningococcal disease
  • People with certain medical conditions that increase their risk of meningococcal infections, such as asplenia (absence of a functioning spleen)[3]
  • Laboratory workers who are routinely exposed to Neisseria meningitidis
  • People at risk during outbreaks of meningococcal B disease

Dosing and Administration

The vaccine is typically administered as an intramuscular injection. The dosing schedule can vary depending on the age and risk factors of the individual. For most people, a series of two or three doses is recommended:[1]

  • Two doses given at least 1 month apart
  • In some cases, a third dose may be given 6 months after the second dose

It’s important to follow the recommended schedule to ensure the best protection against meningococcal B disease.

Effectiveness

Clinical trials have shown that the meningococcal group B vaccine is effective in producing an immune response against various strains of Neisseria meningitidis serogroup B. One study found that after two doses, a high percentage of participants had protective antibody levels against multiple meningococcal B strains.[2]

Safety and Side Effects

The meningococcal group B vaccine has been shown to have a good safety profile in clinical trials. However, like all vaccines, it can cause some side effects. Common side effects may include:[1]

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

Most side effects are mild and resolve within a few days. Serious allergic reactions are rare but can occur. If you experience any severe symptoms after vaccination, seek medical attention immediately.

Use in Special Populations

Research is ongoing to evaluate the safety and effectiveness of the meningococcal group B vaccine in various populations. Some studies are focusing on:

  • Adults with asplenia (absence of a functioning spleen): A study is assessing the immunogenicity and safety of different meningococcal B vaccine strategies in this population.[3]
  • Infants and young children: Studies are evaluating the use of the vaccine in combination with other routine childhood vaccinations.[4]
  • Older adults: Research is being conducted to assess the safety and effectiveness of the vaccine in adults over 65 years of age.[5]

Ongoing Research

Several clinical trials are currently underway to further investigate the meningococcal group B vaccine:

  • A study is examining different dosing schedules in healthy adolescents to optimize the vaccination strategy.[2]
  • Another trial is evaluating a combined vaccine that protects against meningococcal serogroups A, B, C, W, and Y in infants.[4]
  • Researchers are also studying the long-term persistence of antibodies and the potential need for booster doses.[3]

These ongoing studies will help to refine vaccination strategies and ensure the best possible protection against meningococcal disease for various populations.

Trial Aspect Details
Vaccine Components Recombinant Neisseria Meningitidis Group B fHbp, NadA, and NHBA fusion proteins, plus outer membrane vesicles (OMV)
Primary Objectives Assess safety, tolerability, and immunogenicity of meningococcal B vaccines
Study Populations Healthy adolescents, infants, adults with asplenia, patients with specific medical conditions
Key Outcome Measures hSBA titers, seroconversion rates, adverse events, geometric mean titers
Safety Assessments Monitoring of adverse events, injection site reactions, systemic events
Immunogenicity Assessments Measurement of antibody responses using hSBA assays
Study Designs Randomized, controlled, blinded or partially blinded, with varying dosing schedules
Follow-up Periods Range from several months to multiple years for long-term assessment

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, tolerability, and immunogenicity of recombinant Neisseria meningitidis group B vaccines, particularly those containing the fHbp protein. The trials aim to determine the vaccine's effectiveness in producing an immune response and its safety profile in various populations.
  • Who are the target populations for these vaccine trials? The target populations vary across the trials but include healthy adolescents, infants, adults with asplenia (absence of a functioning spleen), and patients with specific medical conditions such as generalized myasthenia gravis and chronic spontaneous urticaria.
  • What is the significance of the fHbp protein in these vaccines? The factor H binding protein (fHbp) is a key component of these vaccines. It is a recombinant protein produced in E. coli cells using DNA technology and is adsorbed on aluminum hydroxide. This protein is designed to stimulate an immune response against Neisseria meningitidis group B, potentially providing protection against meningococcal disease caused by this serogroup.
  • How is the immune response measured in these trials? The immune response is typically measured using a human serum bactericidal antibody (hSBA) assay. This test measures the ability of antibodies in the participants' blood to kill the bacteria. Researchers look at factors such as the percentage of participants achieving certain hSBA titers and the geometric mean titers (GMTs) at various time points after vaccination.
  • What are some of the safety considerations being evaluated? Safety considerations include monitoring for adverse events (AEs) such as injection site reactions, systemic events, and any serious adverse events (SAEs). The trials also assess the tolerability of the vaccines, any impact on vital signs, and potential interactions with other vaccines or medications. Long-term follow-up is often included to evaluate the persistence of the immune response and any delayed adverse effects.

Ongoing Clinical Trials on Recombinant Neisseria Meningitidis Group B Fhbp Fusion 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 MenABCWY Vaccine in Healthy Adolescents Aged 11-14 with Meningococcal Meningitis

    Not recruiting

    2 1
    Investigated drugs:
    Germany

  • 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 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 Neisseria Meningitidis Group B fHbp Fusion Protein: A protein component of meningococcal vaccines produced using DNA technology in E. coli cells, designed to stimulate an immune response against Neisseria meningitidis serogroup B.
  • hSBA (human serum bactericidal antibody) assay: A laboratory test used to measure the ability of antibodies in human serum to kill bacteria, often used to assess the immune response to meningococcal vaccines.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Seroconversion: The development of detectable antibodies in the blood directed against an infectious agent, often used to determine vaccine effectiveness.
  • Geometric Mean Titer (GMT): A measure of the average antibody level in a group of participants, calculated using the geometric mean to reduce the impact of extreme values.
  • Asplenia: The absence of a functioning spleen, either due to surgical removal or impaired function, which can increase susceptibility to certain infections.
  • 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 Extension (OLE): A phase of a clinical trial where all participants receive the active treatment, often following the completion of the initial randomized, controlled phase.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action.

References

  1. http://clinicaltrials.eu/trial-id/2023-508192-36-00
  2. http://clinicaltrials.eu/trial-id/2023-504301-37-00
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-meningococcal-b-vaccines-in-adults-with-asplenia-bexsero-trumenba-and-a-drug-combination/
  4. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  5. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-dnth103-for-adults-with-generalized-myasthenia-gravis/