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Neisseria Meningitidis Group B Fhbp Protein Subfamily B

This article discusses a clinical trial called SPLEMENGO, which aims to assess the safety and immune response of different meningococcal B vaccine strategies in adults who have undergone spleen removal (asplenia). The study focuses on the use of vaccines containing Neisseria Meningitidis Group B Fhbp Protein Subfamily B, specifically comparing the effectiveness of different vaccination approaches in this vulnerable population.

Table of Contents

What is NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B?

NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B is a component of a vaccine designed to protect against meningococcal disease caused by group B Neisseria meningitidis bacteria. This vaccine is part of a product called Trumenba, which is used to prevent a serious bacterial infection that can cause meningitis (inflammation of the protective membranes covering the brain and spinal cord) and sepsis (a life-threatening response to infection).[1]

Purpose of the Vaccine

The primary purpose of this vaccine is to stimulate the immune system to produce antibodies against group B meningococcal bacteria. These antibodies help protect individuals from developing meningococcal disease if they are exposed to the bacteria in the future. The vaccine is particularly important for people who have had their spleen removed (asplenic patients), as they are at higher risk of severe bacterial infections.[1]

Vaccine Composition

Trumenba contains two main components:

  • NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY A: This is one of the two recombinant lipoproteins in the vaccine.
  • NEISSERIA MENINGITIDIS GROUP B FHBP PROTEIN SUBFAMILY B: This is the second recombinant lipoprotein in the vaccine.

These proteins are also known as NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LIPOPROTEIN (RLP2086, SUBFAMILY A) and NEISSERIA MENINGITIDIS SEROGROUP B RECOMBINANT LIPOPROTEIN (RLP2086, SUBFAMILY B), respectively.[1]

Current Clinical Trial: SPLEMENGO

A clinical trial called SPLEMENGO is currently being conducted to assess the effectiveness and safety of Trumenba and other meningococcal B vaccines in adults without a spleen. Here are some key points about the trial:

  • It is a multicenter, randomized, phase III trial.
  • The trial aims to evaluate the immunogenicity (ability to provoke an immune response) and safety of three different meningococcal B vaccine strategies.
  • The primary objective is to assess the immune response one month after completing the vaccination schedule.
  • Secondary objectives include evaluating long-term immunity (up to 48 months), determining factors that influence immune response, and assessing the safety of the vaccines.[1]

Eligibility Criteria for the Trial

To participate in the SPLEMENGO trial, individuals must meet certain criteria. Some key inclusion criteria are:

  • Age: 18 to 75 years old
  • Asplenic (without a spleen) for at least 2 weeks
  • Visible Howell Jolly bodies on blood film (these are abnormal red blood cells that indicate the absence of a functioning spleen)
  • Confirmed splenectomy (surgical removal of the spleen)

Some exclusion criteria include:

  • Previous meningococcal B vaccination
  • Severe acute illness within a week before inclusion
  • History of anaphylaxis (severe allergic reaction) after vaccination
  • Known allergy to vaccine components
  • Recent use of certain medications that may affect the immune system[1]

Vaccine Administration

Trumenba is administered as an intramuscular injection. In the SPLEMENGO trial, participants receive up to three doses of the vaccine over a period of 6 months. The exact dosing schedule may vary depending on the specific vaccine strategy being studied.[1]

Safety Considerations

As with any vaccine, safety is a crucial aspect of the research. The SPLEMENGO trial includes monitoring for both clinical and biological safety of the vaccines. Special attention is given to adults over 65 years of age. Common side effects of vaccines may include pain at the injection site, fatigue, and mild fever, but severe reactions are rare.[1]

Future Research and Data Sharing

The SPLEMENGO trial is designed to provide valuable data on the use of meningococcal B vaccines in asplenic adults. After the study is completed and results are published, individual participant data will be made available to other researchers for further analysis. This data sharing approach aims to maximize the scientific value of the research and potentially lead to additional insights and improvements in meningococcal disease prevention.[1]

Aspect Details
Study Name SPLEMENGO
Study Type Multicenter, randomized, phase III trial
Primary Objective Assess immunogenicity of three meningococcal B vaccine strategies in asplenic adults
Key Vaccine Trumenba (containing Neisseria Meningitidis Group B Fhbp Protein Subfamily A and B)
Participant Age Range 18 to 75 years old
Main Inclusion Criteria Asplenic patients with visible Howell Jolly bodies
Follow-up Duration 4 years from inclusion
Primary Endpoint Proportion of responders one month after completing vaccination
Safety Assessment Clinical and biological safety evaluation for each vaccine strategy

FAQ

  • What is the main goal of the SPLEMENGO clinical trial? The main goal of the SPLEMENGO trial is to assess the immunogenicity (immune response) of three different meningococcal B vaccine strategies in adults with asplenia one month after completing the vaccination schedule.
  • Who can participate in this clinical trial? Participants must be adults aged 18 to 75 years old who have had their spleen removed for at least two weeks. They must have visible Howell Jolly bodies on a blood film and confirmed splenectomy through medical records or ultrasound.
  • What vaccines are being studied in this trial? The trial is studying meningococcal B vaccines, including Trumenba, which contains Neisseria Meningitidis Group B Fhbp Protein Subfamily A and B. The study compares three different vaccine strategies using these vaccines.
  • How long will participants be followed in this study? Participants will be followed for 4 years from the inclusion visit. The study will assess the persistence and evolution of immune response at various time points, including 12, 24, 36, and 48 months after the first immunization.
  • What are some reasons why someone might not be able to participate in this trial? Some exclusion criteria include: previous meningococcal B vaccination, severe allergies to vaccine components, pregnancy or breastfeeding, ongoing chemotherapy, certain immunosuppressive conditions, and participation in other clinical trials.

Ongoing Clinical Trials on Neisseria Meningitidis Group B Fhbp Protein Subfamily B

  • 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

  • Asplenia: A condition where a person does not have a functioning spleen, either due to surgical removal or a medical condition affecting spleen function.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Meningococcal B: Refers to a type of bacteria called Neisseria meningitidis serogroup B, which can cause serious infections like meningitis and sepsis.
  • Seroconversion: The development of detectable antibodies in the blood directed against an infectious agent, indicating an immune response to vaccination or infection.
  • hSBA titer: A measure of the level of functional antibodies in the blood that can kill meningococcal bacteria, used to assess vaccine effectiveness.
  • Howell Jolly bodies: Small, round inclusions in red blood cells that are typically removed by the spleen. Their presence indicates that the spleen is not functioning properly.
  • Trumenba: A meningococcal B vaccine containing recombinant proteins from Neisseria meningitidis group B.
  • Fhbp Protein: Factor H binding protein, a component found on the surface of meningococcal bacteria that is used in some vaccines to stimulate an immune response.

References

  1. 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/