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Pneumococcal Polysaccharide Serotype 15B Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article discusses clinical trials investigating the use of pneumococcal polysaccharide serotype 15B conjugate vaccine, which is part of a 20-valent pneumococcal conjugate vaccine (20vPnC). The trials aim to evaluate the vaccine’s immune response, safety, and effectiveness in preventing pneumococcal disease in different populations. The studies focus on various aspects, including the vaccine’s ability to induce antibody responses, its effectiveness against community-acquired pneumonia, and its potential for co-administration with other vaccines.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 15B Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 15B Conjugated to CRM197 Adsorbed on Aluminium Phosphate is a component of a vaccine called Apexxnar. This vaccine is designed to protect against pneumococcal diseases, which are infections caused by the bacteria Streptococcus pneumoniae.[1]

Composition and Formulation

Apexxnar is a 20-valent pneumococcal conjugate vaccine, which means it contains 20 different serotypes (variants) of pneumococcal bacteria. Each serotype is conjugated (attached) to a carrier protein called CRM197 and adsorbed onto aluminum phosphate. The specific component we’re focusing on is serotype 15B, but it’s important to understand that it works in conjunction with the other 19 serotypes in the vaccine.[1]

How It Works

The vaccine works by stimulating your immune system to produce antibodies against the pneumococcal bacteria. Here’s a simplified explanation of the process:

  • The polysaccharide (a type of sugar molecule) from the bacterial coating of serotype 15B is attached to the CRM197 protein. This combination helps your immune system recognize and respond to the bacteria more effectively.
  • The aluminum phosphate acts as an adjuvant, which means it helps boost your immune response to the vaccine.
  • When you receive the vaccine, your immune system recognizes these components as foreign and produces antibodies against them.
  • If you’re later exposed to the actual pneumococcal bacteria, your immune system will recognize it and be ready to fight it off, potentially preventing infection.

Uses and Indications

Apexxnar, which contains the pneumococcal polysaccharide serotype 15B component, is used to prevent pneumococcal diseases in adults aged 65 and older. These diseases can include:

  • Pneumonia: An infection of the lungs
  • Bacteremia: An infection of the blood
  • Meningitis: An infection of the protective membranes covering the brain and spinal cord

The vaccine is particularly important for older adults because they are at higher risk of severe pneumococcal infections.[2]

Administration

Apexxnar is administered as an intramuscular injection, typically in the upper arm muscle. It’s given as a single 0.5 ml dose. The vaccine comes in a pre-filled syringe, making it easy for healthcare providers to administer.[1]

Effectiveness

Ongoing research is being conducted to evaluate the effectiveness of Apexxnar, including its serotype 15B component. One study is looking at the vaccine’s ability to prevent vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older. The effectiveness is measured by comparing the occurrence of pneumonia in vaccinated versus unvaccinated individuals.[3]

Safety and Side Effects

While specific safety data for the serotype 15B component alone isn’t available, the overall safety profile of Apexxnar is being studied. As with any vaccine, some people may experience side effects. Common side effects of pneumococcal vaccines can include:

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

Serious allergic reactions are rare but possible. Always discuss potential risks and benefits with your healthcare provider.[2]

Ongoing Research

Several clinical trials are currently underway to further study Apexxnar and its components, including the serotype 15B polysaccharide:

  • A study is examining the immune response when Apexxnar is co-administered with a respiratory syncytial virus (RSV) vaccine in adults aged 60 and older.[2]
  • Another study is investigating the effectiveness of Apexxnar in preventing pneumonia in adults aged 65 and older.[3]
  • Researchers are also studying the vaccine’s ability to stimulate an immune response in the lymph nodes, which play a crucial role in the immune system.[1]

These studies aim to provide more information about the vaccine’s effectiveness, safety, and how it works in the body, which will help healthcare providers make informed decisions about its use.

Aspect Details
Vaccine Composition 20-valent pneumococcal conjugate vaccine (20vPnC) including serotype 15B
Primary Study Populations Adults aged 60 years and older, with some studies including younger adults
Key Objectives Evaluate immune response, safety, and effectiveness against pneumococcal disease
Main Outcome Measures Antibody levels, opsonophagocytic activity, prevention of community-acquired pneumonia
Study Designs Randomized controlled trials, test-negative design for effectiveness studies
Co-administration Studies Evaluation of 20vPnC with RSV vaccine in older adults
Safety Assessments Monitoring of adverse events, reactogenicity, and serious adverse events
Specific Serotype Focus Includes evaluation of serotype 15B along with other serotypes in 20vPnC

FAQ

  • What is the main purpose of the 20-valent pneumococcal conjugate vaccine (20vPnC)? The main purpose of the 20vPnC is to prevent pneumococcal disease caused by 20 different serotypes of Streptococcus pneumoniae bacteria, including serotype 15B. It is designed to induce an immune response that protects against these specific strains of pneumococcus.
  • Who are the target populations for these clinical trials? The clinical trials target various populations, including healthy adults aged 60 years and older, as well as younger adults in some studies. One trial specifically focuses on adults aged 65 years and older to evaluate the vaccine's effectiveness against community-acquired pneumonia.
  • What are the primary outcomes being measured in these trials? The primary outcomes vary between trials but generally include measures of immune response, such as antibody levels and opsonophagocytic activity, as well as the vaccine's effectiveness in preventing pneumococcal disease. Some trials also assess safety and reactogenicity of the vaccine.
  • How is the effectiveness of the vaccine being evaluated? The vaccine's effectiveness is being evaluated through various methods, including measuring antibody responses, assessing the prevention of radiologically-confirmed community-acquired pneumonia, and comparing vaccinated individuals to control groups. Some studies use a test-negative design to determine vaccine effectiveness in real-world settings.
  • Are there any studies looking at co-administration with other vaccines? Yes, one of the trials is investigating the co-administration of the 20vPnC with a respiratory syncytial virus (RSV) vaccine in adults aged 60 years and older. This study aims to evaluate the immune responses and safety when these vaccines are given together compared to when they are administered separately.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 15B Conjugated To Crm197 Adsorbed On Aluminium Phosphate

  • 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

  • Study of Pneumococcal Vaccine Response in Patients Without a Spleen: Comparing Vaccination Before and After Spleen Removal Using PCV20 and PCV21

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Pneumococcal Vaccine Response in Healthy Volunteers Using Pneumococcal Polysaccharide Conjugate Vaccine and Drug Combination

    Recruiting

    2 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of the 20-Valent Pneumococcal Vaccine in Adults with Fever and High Risk for Pneumococcal Infection

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effectiveness of 20-Valent Pneumococcal Conjugate Vaccine for Preventing Pneumonia in Adults Aged 65 and Older

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on the Effectiveness of Pneumococcal Vaccines PCV13 and PPV23 in Adults with Acute Leukemia or Lymphoma Undergoing Chemotherapy

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study of RSV vaccine and pneumococcal vaccine combination for patients aged 60 and older with chronic obstructive pulmonary disease

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of 20-valent pneumococcal conjugate vaccine (PCV20) booster response in healthy adults aged 78-84 years

    Not recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland Spain

Glossary

  • Pneumococcal polysaccharide serotype 15B: A specific type of sugar molecule found on the surface of certain pneumococcal bacteria. It is one of the 20 serotypes included in the 20-valent pneumococcal conjugate vaccine.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response, especially in young children and older adults.
  • Opsonophagocytic activity: A measure of the immune system's ability to recognize, attach to, and engulf (phagocytose) bacteria, which is enhanced by antibodies produced in response to vaccination.
  • Community-acquired pneumonia (CAP): A type of pneumonia that is acquired outside of healthcare settings, often caused by bacteria such as Streptococcus pneumoniae.
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through chest X-ray or other imaging techniques, showing characteristic signs of lung infection.
  • Serotype: A distinct variation within a species of bacteria, characterized by specific surface structures that can be identified by the immune system.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a stronger antigen to create a more powerful immune response, especially in certain age groups.
  • Test-negative design: A study design used to evaluate vaccine effectiveness by comparing vaccination status among individuals who test positive for a disease to those who test negative.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Reactogenicity: The capacity of a vaccine to produce common, expected adverse reactions, usually mild and self-limited, such as pain at injection site or fever.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2022-501988-40-00
  3. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/