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

This article summarizes clinical trials investigating the use of a recombinant Neisseria meningitidis group B NHBA fusion protein vaccine produced in E. coli cells and adsorbed on aluminum hydroxide. This vaccine is being studied for prevention of meningococcal disease caused by Neisseria meningitidis bacteria. The trials examine the vaccine’s safety, tolerability, and ability to produce an immune response in different populations, including healthy adolescents, infants, and adults with certain medical conditions.

Table of Contents

What is this vaccine?

This vaccine, known by the brand name Bexsero, is a recombinant vaccine designed to protect against meningococcal disease caused by Neisseria meningitidis serogroup B bacteria.[1] It 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 recognizes the proteins and can quickly mount a defense, preventing infection.[1]

What does it treat?

This vaccine is designed to prevent meningococcal disease caused by Neisseria meningitidis serogroup B. Meningococcal disease can lead to serious conditions such as:

  • Meningitis (infection of the lining of the brain and spinal cord)
  • Septicemia (blood infection)

These conditions can be life-threatening and may cause severe long-term complications in survivors.[1]

How is it administered?

The vaccine is given as an intramuscular injection, typically in the upper arm or thigh. The dosing schedule may vary depending on the age of the recipient and the specific vaccination strategy being used. In general:

  • Infants and young children may receive multiple doses starting as early as 2 months of age
  • Adolescents and adults typically receive 2 doses, with the second dose given at least 1 month after the first

Your healthcare provider will determine the appropriate schedule based on your age and risk factors.[1]

How effective is it?

Clinical trials have shown that the vaccine is effective in producing an immune response against meningococcal B strains. The effectiveness is measured by looking at the percentage of people who develop protective antibody levels after vaccination. While the exact level of protection can vary, studies have shown that a significant proportion of vaccinated individuals develop protective antibody levels against multiple meningococcal B strains.[1]

Is it safe?

The vaccine has been extensively studied and has a good safety profile. It has been approved for use by regulatory agencies in many countries, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). As with all vaccines, it undergoes continuous safety monitoring.[1]

What are the potential side effects?

Like all vaccines, this one can cause side effects, although not everyone experiences them. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fever
  • Irritability
  • Drowsiness
  • Loss of appetite
  • Muscle and joint pain

Most side effects are mild and resolve within a few days. Serious allergic reactions are rare but can occur. Your healthcare provider can provide more information about potential side effects.[1]

Who should get this vaccine?

The vaccine is recommended for individuals at increased risk of meningococcal disease, including:

  • Infants and young children
  • Adolescents
  • People with certain medical conditions that weaken the immune system
  • Laboratory workers who may be exposed to meningococcal bacteria
  • People living in or traveling to areas with high rates of meningococcal disease

It’s particularly important for people with asplenia (absence of a functioning spleen) to receive this vaccine, as they are at higher risk of severe bacterial infections.[2]

What ongoing research is being done?

Several clinical trials are currently underway to further evaluate the safety, effectiveness, and optimal use of this vaccine:

  • A study is assessing the vaccine’s safety and immune response in healthy adolescents aged 11 to 14 years, comparing different dosing schedules.[1]
  • Another trial is evaluating the vaccine’s immunogenicity and safety in adult patients with asplenia, comparing it to healthy controls.[2]
  • A multicenter study is comparing three different meningococcal B vaccine strategies in adults with asplenia.[3]

These ongoing studies aim to provide more data on the vaccine’s performance in different populations and to optimize vaccination strategies for maximum protection against meningococcal disease.

Trial Aspect Details
Vaccine Components Recombinant Neisseria meningitidis group B NHBA, NadA, and fHbp fusion proteins, plus outer membrane vesicles
Study Populations Healthy adolescents, infants, adults with asplenia, adults with generalized myasthenia gravis
Primary Objectives Safety, tolerability, immunogenicity of different dosing schedules
Key Outcome Measures Adverse events, antibody responses (hSBA titers), seroconversion rates
Administration Intramuscular injection, 2-3 doses over months
Follow-up Duration Varies by trial, some up to 48 months post-vaccination

Ongoing Clinical Trials on Recombinant Neisseria Meningitidis Group B Nhba 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
    Italy Spain
  • A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

    Recruiting

    1 1 1
    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
    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:
    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
    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
    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
    Austria
  • Study on the Safety and Immune Response of MenABCWY Vaccine in Healthy Adolescents Aged 11-14 with Meningococcal Meningitis

    Not recruiting

    2 1
    Germany
  • Study on the Safety and Tolerability of DNTH103 for Adults with Generalized Myasthenia Gravis

    Not recruiting

    2 1 1
    Investigated diseases:
    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:
    France

Glossary

  • Meningococcal disease: A serious bacterial infection caused by Neisseria meningitidis that can lead to meningitis (inflammation of the membranes covering the brain and spinal cord) and septicemia (blood infection).
  • Recombinant protein: A protein produced using genetic engineering techniques, where the gene for the desired protein is inserted into bacteria or other cells to manufacture the protein.
  • NHBA fusion protein: Neisseria Heparin Binding Antigen, a protein found on the surface of meningococcal bacteria that is used as a vaccine component.
  • Adsorbed on aluminum hydroxide: The vaccine proteins are attached to aluminum compounds, which help stimulate a stronger immune response.
  • 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.
  • hSBA titer: Human Serum Bactericidal Antibody titer, a measure of functional antibodies in the blood that can kill meningococcal bacteria.
  • Asplenia: The absence of a functioning spleen, either due to surgical removal or impaired function.
  • Myasthenia gravis: An autoimmune disorder causing muscle weakness and fatigue.

References

  1. http://clinicaltrials.eu/trial-id/2023-504301-37-00
  2. http://clinicaltrials.eu/trial-id/2023-508192-36-00
  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/