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Pneumococcal Polysaccharide Serotype 8 Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article discusses clinical trials investigating the use of pneumococcal polysaccharide serotype 8 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 8 Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 8 Conjugated to CRM197 Adsorbed on Aluminium Phosphate is a component of a vaccine designed to protect against pneumococcal diseases. It’s a bit of a mouthful, so let’s break it down:

  • Pneumococcal Polysaccharide: This is a sugar molecule from the outer coating of the pneumococcus bacteria.
  • Serotype 8: This refers to a specific strain of the pneumococcus bacteria.
  • Conjugated to CRM197: The sugar molecule is attached to a harmless protein called CRM197, which helps the immune system recognize and respond to the vaccine better.
  • Adsorbed on Aluminium Phosphate: This means the vaccine component is attached to a substance called aluminum phosphate, which helps to boost the immune response.[1]

How Does It Work?

This vaccine component works by mimicking part of the pneumococcus bacteria. When introduced into the body, it triggers an immune response without causing the actual disease. This prepares your immune system to fight off real pneumococcal infections in the future.[1]

Part of a Larger Vaccine

It’s important to note that this component is just one part of a larger vaccine called Apexxnar. Apexxnar is a 20-valent pneumococcal conjugate vaccine, which means it protects against 20 different serotypes (strains) of pneumococcus bacteria. Serotype 8 is one of these 20 strains.[2]

Effectiveness

Studies are ongoing to determine the effectiveness of this vaccine component and the overall Apexxnar vaccine. One study aims to evaluate the vaccine’s effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older.[3]

How is it Administered?

The vaccine containing this component is given as an intramuscular injection, typically in the upper arm. For adults, it’s usually given as a single 0.5 ml dose.[2]

Who Can Receive This Vaccine?

The Apexxnar vaccine, which includes this component, is approved for use in adults aged 18 years and older. It’s particularly important for older adults and those with certain medical conditions that increase their risk of pneumococcal disease.[2]

Safety and Side Effects

Like all vaccines, Apexxnar can cause side effects, although not everyone gets them. Common side effects may include pain at the injection site, fatigue, and muscle pain. Serious allergic reactions are rare but possible. Always consult with your healthcare provider about potential risks and benefits.[2]

Ongoing Research

Research is ongoing to further understand the effectiveness and safety of this vaccine component and the overall Apexxnar vaccine. One study is investigating the immune response when Apexxnar is co-administered with an RSV (Respiratory Syncytial Virus) vaccine in older adults.[2] Another study is looking at the vaccine’s effectiveness against community-acquired pneumonia in adults aged 65 and older.[3]

In conclusion, Pneumococcal Polysaccharide Serotype 8 Conjugated to CRM197 Adsorbed on Aluminium Phosphate is an important component of a vaccine designed to protect against pneumococcal diseases. As part of the Apexxnar vaccine, it contributes to providing broad protection against multiple strains of pneumococcus bacteria. Ongoing research continues to evaluate its effectiveness and safety in various populations.

Trial Aspect Details
Vaccine Studied 20-valent pneumococcal conjugate vaccine (20vPnC), including pneumococcal polysaccharide serotype 8
Main Objectives Evaluate immune response, safety, and effectiveness against pneumococcal disease
Target Populations Adults aged 60 and older, with focus on 65+ in some trials; healthy volunteers 20-40 years old in one study
Key Outcomes Measured Antibody responses, prevention of community-acquired pneumonia, germinal center B cell frequencies, opsonophagocytic antibody titers
Study Designs Randomized controlled trials, test-negative design, open-label studies
Safety Assessments Monitoring of adverse events, reactogenicity, and serious adverse events
Co-administration Studies Evaluation of 20vPnC when given with other vaccines (e.g., RSV vaccine)
Innovative Techniques Lymph node fine needle aspiration to study vaccine-induced immunity

FAQ

  • What is the main purpose of these clinical trials? The main purposes of these clinical trials are to evaluate the immune response, safety, and effectiveness of the 20-valent pneumococcal conjugate vaccine (20vPnC), which includes pneumococcal polysaccharide serotype 8. The trials aim to assess the vaccine's ability to prevent pneumococcal disease, particularly in adults aged 65 and older.
  • How is the vaccine's effectiveness being measured? The vaccine's effectiveness is being measured through various methods, including assessing antibody responses, evaluating its ability to prevent radiologically-confirmed community-acquired pneumonia, and comparing vaccinated and unvaccinated groups. Some trials use a test-negative design to calculate vaccine effectiveness against specific pneumococcal serotypes.
  • Who are the target populations for these clinical trials? The target populations vary across the trials but generally include adults aged 60 years and older, and in some cases, specifically focus on adults aged 65 and older. One trial also includes healthy volunteers between the ages of 20 and 40 years old to study vaccine-induced immunity mechanisms.
  • What are some of the key outcomes being studied? Key outcomes being studied include the percentage of germinal center B cells in lymph node aspirates, opsonophagocytic antibody titers for pneumococcal vaccine serotypes, vaccine effectiveness against community-acquired pneumonia, and safety and reactogenicity of the vaccine when administered alone or co-administered with other vaccines.
  • Are there any specific exclusion criteria for participants? Yes, there are several exclusion criteria across the trials. These may include recent pneumococcal vaccination, certain medical conditions (e.g., immunodeficiency, coagulation disorders), pregnancy, and use of immunosuppressive medications. Specific criteria vary between trials, so potential participants should consult the detailed eligibility requirements for each study.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 8 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 8: A specific type of pneumococcal bacteria covered by the 20-valent pneumococcal conjugate vaccine. It is one of the serotypes responsible for causing pneumococcal diseases.
  • 20vPnC: 20-valent pneumococcal conjugate vaccine, which provides protection against 20 different serotypes of pneumococcal bacteria.
  • Opsonophagocytic antibody titers: A measure of the functional antibodies that can facilitate the uptake and killing of pneumococcal bacteria by immune cells.
  • Germinal center B cells: Specialized B cells found in lymphoid tissues that are crucial for producing high-affinity antibodies and generating immune memory.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, typically in the general community.
  • Radiologically-confirmed pneumonia: Pneumonia that has been confirmed through chest imaging techniques such as X-rays or CT scans.
  • 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.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome (e.g., disease or infection) in real-world conditions.
  • Reactogenicity: The capacity of a vaccine to produce common, expected adverse reactions, usually at the injection site or systemically.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.

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/