#1 Clinical Trials Search in Europe

Pneumococcal Polysaccharide Serotype 10A Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article discusses clinical trials investigating the use of a 20-valent pneumococcal conjugate vaccine (20vPnC) in adults. The trials aim to evaluate the vaccine’s effectiveness against pneumococcal disease, particularly community-acquired pneumonia (CAP), in older adults. The studies focus on assessing immune responses, safety profiles, and real-world effectiveness of the vaccine in preventing pneumococcal infections caused by various serotypes included in the vaccine formulation.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 10A Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 10A Conjugated to CRM197 Adsorbed on Aluminium Phosphate is a component of a vaccine designed to protect against pneumococcal diseases. It is part of a larger vaccine called Apexxnar, which is a 20-valent pneumococcal conjugate vaccine[1].

To break this down into simpler terms:

  • Pneumococcal refers to the bacteria Streptococcus pneumoniae, which can cause various infections.
  • Polysaccharide is a type of sugar molecule found on the surface of the bacteria.
  • Serotype 10A is a specific strain of the pneumococcal bacteria.
  • Conjugated to CRM197 means the polysaccharide is attached to a carrier protein (CRM197) to enhance the immune response.
  • Adsorbed on Aluminium Phosphate indicates that the vaccine component is attached to an aluminum compound, which acts as an adjuvant to boost the immune response.

How Does This Vaccine Component Work?

This vaccine component works by stimulating your immune system to produce antibodies against the specific pneumococcal serotype 10A. When your body encounters this serotype in the future, it can quickly recognize and fight off the bacteria, preventing infection[1].

Part of a Larger Vaccine

It’s important to note that this component is just one part of the Apexxnar vaccine. Apexxnar contains 20 different pneumococcal serotypes, each conjugated to CRM197 and adsorbed on aluminum phosphate. This broad coverage helps protect against multiple strains of pneumococcal bacteria[1].

Clinical Trials and Research

Several clinical trials have been conducted to study the effectiveness and safety of the Apexxnar vaccine, which includes the serotype 10A component. These studies aim to understand how well the vaccine works in different populations and situations[2].

One study is looking at the immune response when Apexxnar is given along with a respiratory syncytial virus (RSV) vaccine in adults aged 60 and older. This research helps determine if the vaccines can be safely and effectively administered together[1].

Effectiveness and Benefits

The effectiveness of the vaccine, including the serotype 10A component, is being studied in various populations. One large-scale study is evaluating the vaccine’s effectiveness against community-acquired pneumonia in adults 65 years and older[2].

This research aims to determine:

  • How well the vaccine prevents pneumonia caused by the vaccine serotypes
  • The effectiveness in different age groups and populations
  • How the vaccine performs in people with various health conditions
  • The impact of prior vaccinations on the vaccine’s effectiveness

Administration and Dosage

The Apexxnar vaccine, which includes the serotype 10A component, is typically administered as a single 0.5 ml dose via intramuscular injection. It’s usually given in the upper arm (deltoid muscle) for adults[1].

Safety and Side Effects

As with any vaccine, there can be side effects. Common side effects may include pain at the injection site, fatigue, muscle pain, and headache. Serious side effects are rare. The ongoing clinical trials are closely monitoring the safety profile of the vaccine[2][2].

Conclusion

Pneumococcal Polysaccharide Serotype 10A Conjugated to CRM197 Adsorbed on Aluminium Phosphate is an important component of the Apexxnar vaccine. As part of this broader vaccine, it helps protect against pneumococcal diseases caused by the 10A serotype. Ongoing research continues to evaluate its effectiveness and safety in various populations, contributing to our understanding of how to best prevent pneumococcal diseases.

Aspect Details
Vaccine 20-valent pneumococcal conjugate vaccine (20vPnC)
Target Population Adults aged 65 years and older
Primary Objectives Evaluate effectiveness against community-acquired pneumonia, assess immune responses, and determine safety profile
Study Designs Phase 3 and 4 clinical trials, including test-negative design and real-world effectiveness studies
Key Outcomes Antibody titers, opsonophagocytic activity, prevention of radiologically-confirmed pneumonia, safety and reactogenicity
Comparisons 20vPnC vs. 13vPnC, co-administration with other vaccines (e.g., influenza)
Safety Assessments Monitoring of adverse events, serious adverse events, and potential immune-mediated diseases
Additional Analyses Effectiveness by age groups, sex, chronic medical conditions, and prior vaccination history

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the effectiveness of the 20-valent pneumococcal conjugate vaccine (20vPnC) in preventing pneumococcal disease, particularly community-acquired pneumonia, 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 immune responses by measuring antibody levels, evaluating safety and reactogenicity, and conducting real-world studies to determine the vaccine's impact on preventing pneumococcal infections.
  • Who are the target participants for these trials? The target participants are generally adults aged 65 years and older. Some trials may include healthy volunteers or those with stable medical conditions, while excluding individuals with certain health issues or recent vaccinations.
  • What are some of the key outcomes being studied? Key outcomes include the vaccine's ability to induce antibody responses against various pneumococcal serotypes, its safety profile, and its effectiveness in preventing radiologically-confirmed community-acquired pneumonia caused by vaccine serotypes.
  • Are there any comparisons being made to other pneumococcal vaccines? Yes, some trials are comparing the effectiveness of the 20vPnC against pneumococcal serotypes covered by previous vaccines, such as the 13-valent pneumococcal conjugate vaccine (13vPnC), to assess the added benefit of the additional serotypes included in 20vPnC.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 10A 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 conjugate vaccine: A vaccine that helps protect against diseases caused by pneumococcal bacteria. It contains purified capsular polysaccharides from multiple serotypes of Streptococcus pneumoniae conjugated to a carrier protein.
  • Community-acquired pneumonia (CAP): A type of pneumonia that is acquired outside of healthcare settings, typically in the community. It is often caused by bacteria, including Streptococcus pneumoniae.
  • Serotype: A distinct variation within a species of bacteria or virus, characterized by specific surface structures. In the context of pneumococcal vaccines, it refers to different types of pneumococcal bacteria targeted by the vaccine.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic antibody titers: A measure of functional antibodies that can facilitate the ingestion and killing of bacteria by immune cells, used to assess the effectiveness of pneumococcal vaccines.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome in real-world conditions, often expressed as a percentage reduction in disease risk among vaccinated individuals compared to unvaccinated individuals.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response to polysaccharide antigens.
  • Aluminium phosphate: An adjuvant used in vaccines to enhance the immune response to the vaccine antigens.
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through chest imaging techniques such as X-rays or CT scans, showing characteristic signs of lung infection.
  • Test-negative design: A study design used in vaccine effectiveness research where individuals with the target condition (e.g., pneumonia) are compared to those without the condition in terms of their vaccination status.

References

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