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Pneumococcal Polysaccharide Serotype 12F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article examines clinical trials investigating the use of a 20-valent pneumococcal conjugate vaccine (20vPnC) in adult populations. The vaccine, which contains pneumococcal polysaccharide serotypes conjugated to CRM197 and adsorbed on aluminum phosphate, is being studied for its effectiveness in preventing pneumococcal disease in older adults. The trials aim to evaluate the vaccine’s immunogenicity, safety, and ability to protect against community-acquired pneumonia caused by vaccine serotypes.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 12F 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 found on the surface of pneumococcal bacteria.
  • Serotype 12F: This refers to a specific strain of pneumococcal bacteria.
  • Conjugated to CRM197: The polysaccharide is attached to a protein called CRM197, which helps boost the immune response.
  • Adsorbed on Aluminium Phosphate: This means the vaccine component is attached to aluminum phosphate, which acts as an adjuvant to further enhance the immune response.

This component is part of a larger vaccine called Apexxnar, which is a 20-valent pneumococcal conjugate vaccine. “20-valent” means it protects against 20 different serotypes of pneumococcal bacteria[1].

How Does It Work?

The vaccine works by stimulating your immune system to produce antibodies against the pneumococcal bacteria. Here’s how:

  1. The polysaccharide from the bacterial surface is recognized by your immune system as foreign.
  2. By attaching it to the CRM197 protein, the immune response is enhanced, especially in young children.
  3. The aluminum phosphate further boosts this response.
  4. Your body produces antibodies against the polysaccharide.
  5. If you’re later exposed to the real bacteria, your immune system can quickly recognize and fight it off.

Part of a Larger Vaccine

This component is just one part of the Apexxnar vaccine. The full vaccine includes 20 different serotypes of pneumococcal bacteria, each prepared in a similar way. This broad coverage helps protect against many strains of pneumococcal disease[2].

Clinical Trials and Research

Several clinical trials have been conducted to study the effectiveness and safety of this vaccine component as part of Apexxnar. For example:

  • A Phase III study is evaluating the vaccine’s effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older[3].
  • Another study is looking at the immune response when the vaccine is co-administered with an RSV vaccine in older adults[2].

Effectiveness and Benefits

The effectiveness of this vaccine component, as part of Apexxnar, is being studied in various ways:

  • Researchers are looking at how well it prevents pneumococcal pneumonia in older adults[3].
  • They’re also studying how effective it is in different groups of people, such as those with chronic medical conditions or compromised immune systems[3].
  • The vaccine’s ability to produce an immune response (immunogenicity) is being evaluated[2].

Administration and Dosage

Apexxnar, which contains this vaccine component, is typically administered as follows:

  • It’s given as an intramuscular injection, usually in the upper arm[1].
  • The standard dose is 0.5 ml[1].
  • In some studies, it’s being given as a single dose to adults aged 65 and older[3].

Safety and Side Effects

As with any vaccine, safety is a crucial consideration. Clinical trials are monitoring for potential side effects, including:

  • Local reactions at the injection site, such as pain or swelling[2].
  • Systemic reactions like fever or fatigue[2].
  • Any serious adverse events or unexpected medical problems[2][3].

It’s important to note that vaccines go through rigorous testing for safety before they’re approved for use.

Conclusion

Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197 Adsorbed on Aluminium Phosphate is an important component of the Apexxnar vaccine. As part of this vaccine, it helps protect against pneumococcal diseases, which can be serious, especially in older adults and those with weakened immune systems. Ongoing research continues to evaluate its effectiveness and safety, contributing to our understanding of how to best prevent pneumococcal infections.

Aspect Details
Vaccine Studied 20-valent pneumococcal conjugate vaccine (20vPnC)
Main Target Population Adults aged 65 years and older
Primary Objectives Evaluate effectiveness against community-acquired pneumonia, assess immunogenicity and safety
Key Outcome Measures Antibody titers, vaccine effectiveness, safety and reactogenicity
Study Designs Phase III and IV trials, including randomized controlled and test-negative designs
Comparisons Co-administration with other vaccines (e.g., RSV vaccine), comparison to previous 13-valent vaccine
Safety Assessments Monitoring of adverse events, including serious adverse events and potential immune-mediated disorders
Additional Analyses Effectiveness by age groups, sex, chronic medical conditions, and prior vaccination history

FAQ

  • What is the main purpose of the 20-valent pneumococcal conjugate vaccine? The main purpose of the 20-valent pneumococcal conjugate vaccine (20vPnC) is to prevent pneumococcal disease, particularly community-acquired pneumonia, in adults aged 65 and older. It contains 20 different serotypes of pneumococcal bacteria to provide broader protection against various strains.
  • How is the effectiveness of the vaccine being measured in these trials? The effectiveness of the vaccine is being measured through various methods, including: 1) Opsonophagocytic antibody titers for each pneumococcal serotype, 2) RSV-A and RSV-B neutralizing antibody titers, 3) Vaccine effectiveness against radiologically-confirmed community-acquired pneumonia caused by vaccine serotypes, and 4) Safety and reactogenicity assessments.
  • Who are the main participants in these clinical trials? The main participants in these clinical trials are adults aged 65 years and older. Some trials also include healthy volunteers aged 60 years and above. Participants are generally required to be medically stable and capable of complying with study protocols.
  • What are some of the exclusion criteria for these trials? Some common exclusion criteria include: previous pneumococcal vaccination within a certain timeframe, immunosuppressive conditions, use of immunosuppressive medications, severe allergic reactions to vaccine components, and certain chronic medical conditions that may interfere with the study outcomes.
  • How long do these clinical trials typically last? The duration of these clinical trials varies, but they generally involve follow-up periods of several months to assess vaccine effectiveness and safety. Some trials may monitor participants for up to 6 months after vaccination to evaluate long-term outcomes and potential adverse events.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 12F 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

  • 20vPnC: 20-valent pneumococcal conjugate vaccine, a vaccine containing 20 different serotypes of pneumococcal bacteria conjugated to a carrier protein (CRM197) and adsorbed on aluminum phosphate.
  • Serotype: A distinct variation within a species of bacteria, in this case, different strains of Streptococcus pneumoniae that the vaccine targets.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, typically caused by various pathogens including Streptococcus pneumoniae.
  • Opsonophagocytic antibody titers: A measure of the functional antibodies that can facilitate the ingestion and killing of bacteria by immune cells, used to assess vaccine-induced immunity.
  • RSV: Respiratory Syncytial Virus, a common respiratory virus that can cause severe illness in older adults and is sometimes studied alongside pneumococcal vaccines.
  • 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.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome in real-world conditions, often expressed as a percentage.
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through chest imaging techniques such as X-rays or CT scans.

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/