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Pneumococcal Polysaccharide Serotype 12F Conjugated To Crm197

This article summarizes clinical trials investigating the use of pneumococcal polysaccharide serotype 12F conjugated to CRM197 as part of pneumococcal conjugate vaccines. These trials aim to evaluate the safety, immune response, and effectiveness of next-generation pneumococcal vaccines containing this and other serotypes in preventing pneumococcal disease in various populations. The studies examine factors like antibody responses, opsonophagocytic activity, and vaccine efficacy against pneumonia in adults and at-risk groups.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197 is a component of certain pneumococcal vaccines. It is designed to protect against infections caused by the 12F serotype of Streptococcus pneumoniae, a bacterium responsible for various diseases including pneumonia, meningitis, and bloodstream infections.[1]

This vaccine component consists of two main parts:

  • Pneumococcal polysaccharide serotype 12F: This is a sugar molecule found on the surface of the 12F strain of pneumococcus bacteria.
  • CRM197: This is a non-toxic variant of diphtheria toxin that acts as a carrier protein.

The polysaccharide is chemically linked (conjugated) to the CRM197 protein to enhance the immune response, especially in young children and older adults.[1]

How Does it Work?

When introduced into the body, Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197 stimulates the immune system to produce antibodies against the 12F serotype of pneumococcus. The conjugation to CRM197 is crucial because it helps to create a stronger, longer-lasting immune response.

The process works as follows:

  1. The vaccine component is recognized by the immune system
  2. B cells (a type of white blood cell) are activated
  3. These B cells produce antibodies specific to the 12F serotype
  4. Memory B cells are created, providing long-term immunity

This means that if the person later encounters the 12F serotype of pneumococcus, their immune system can quickly recognize and fight off the bacteria, preventing infection.[1]

What is it Used For?

Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197 is used as part of vaccines to prevent pneumococcal diseases. These vaccines are typically recommended for:

  • Infants and young children
  • Adults 65 years and older
  • People with certain medical conditions that increase their risk of pneumococcal disease

The 12F serotype is included in some newer pneumococcal vaccines because it is one of the serotypes that can cause serious invasive disease. By including this serotype, the vaccines offer broader protection against pneumococcal infections.[2]

Clinical Trials and Research

Several clinical trials have been conducted or are ongoing to evaluate the safety and efficacy of pneumococcal vaccines containing the 12F serotype conjugate. Some key findings include:

  • A Phase III trial is evaluating a 20-valent pneumococcal conjugate vaccine (which includes serotype 12F) in adults aged 65 and older. This study aims to determine the vaccine’s effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia.[3]
  • Another Phase III trial is studying a 21-valent pneumococcal conjugate vaccine (also including serotype 12F) in adults aged 18 to 64 who are at increased risk for pneumococcal disease. This study is assessing the vaccine’s safety, tolerability, and immune response.[4]
  • Research is also being conducted on the use of these vaccines in children and adolescents at higher risk for pneumococcal disease.[5]

These studies are helping to establish the effectiveness of including the 12F serotype in pneumococcal vaccines for various age groups and risk populations.

How is it Administered?

Pneumococcal vaccines containing the 12F serotype conjugate are typically administered as an intramuscular injection. The specific dosing schedule can vary depending on the vaccine and the person’s age and risk factors. For example:

  • For adults, it’s often given as a single 0.5 ml dose[6]
  • For children, the schedule may involve multiple doses given at different ages

Always follow the vaccination schedule recommended by your healthcare provider or national immunization guidelines.

Safety and Side Effects

Pneumococcal vaccines containing the 12F serotype conjugate have generally been found to be safe and well-tolerated. However, like all vaccines, they can cause some side effects. Common side effects may include:

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

These side effects are usually mild and resolve on their own within a few days. Serious allergic reactions are rare but can occur. If you experience any severe or persistent symptoms after vaccination, contact your healthcare provider immediately.[6]

Conclusion

Pneumococcal Polysaccharide Serotype 12F Conjugated to CRM197 is an important component of some newer pneumococcal vaccines. It helps protect against a specific strain of pneumococcus that can cause serious infections. As part of broader pneumococcal vaccines, it contributes to preventing pneumonia, meningitis, and other invasive diseases caused by Streptococcus pneumoniae.

Ongoing research continues to evaluate its effectiveness in different populations and age groups. As with any medical intervention, it’s important to discuss the benefits and potential risks of pneumococcal vaccination with your healthcare provider to determine if it’s appropriate for you or your child.

Trial Focus Key Endpoints Population Vaccine
Immune response kinetics Germinal center B cell frequency, T follicular helper cell frequency Healthy adults 20-40 years old 20-valent pneumococcal conjugate vaccine
Co-administration with RSV vaccine OPA antibody titers, safety/tolerability Adults ≥60 years old 20-valent pneumococcal conjugate vaccine
Immunogenicity vs PPSV23 OPA GMTs, IgG GMCs, ≥4-fold antibody rises Adults ≥50 years old 21-valent pneumococcal conjugate vaccine (V116)
Safety and immunogenicity in high-risk groups Adverse events, OPA GMTs, IgG GMCs Adults 18-64 years at increased risk 21-valent pneumococcal conjugate vaccine (V116)
Vaccine effectiveness against pneumonia Vaccine efficacy against radiologically-confirmed CAP Adults ≥65 years old 20-valent pneumococcal conjugate vaccine

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immune response, and effectiveness of new pneumococcal conjugate vaccines containing serotype 12F and other serotypes in preventing pneumococcal disease in different populations.
  • Which age groups are being studied in these trials? The trials are studying various age groups, including adults 50 years and older, adults 60 years and older, adults 18-64 years at increased risk of pneumococcal disease, and children/adolescents at increased risk.
  • What are some of the key outcomes being measured? Key outcomes include antibody responses, opsonophagocytic activity, vaccine efficacy against pneumonia, safety/adverse events, and immune responses in different risk groups.
  • How is the immune response being evaluated? The immune response is being evaluated through measurements like opsonophagocytic antibody titers, IgG concentrations, and fold-rises in antibody levels compared to baseline.
  • Are these vaccines being compared to existing pneumococcal vaccines? Yes, some trials are comparing the new vaccines to existing pneumococcal vaccines like PPSV23 (23-valent pneumococcal polysaccharide vaccine) to assess relative immunogenicity and efficacy.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 12F Conjugated To Crm197

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

    Recruiting

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

  • Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany Spain

  • Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Poland Spain Sweden

  • Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

    Not recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Opsonophagocytic activity (OPA): A measure of antibody function that reflects the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells. It is an important indicator of vaccine-induced immunity against pneumococcal disease.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on the cell surface. For pneumococcal bacteria, different serotypes are distinguished by their unique polysaccharide capsules.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a protein carrier in conjugate vaccines to enhance the immune response, especially in young children.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation. Measuring IgG levels helps assess the strength of the immune response to vaccination.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people that reduces the impact of very high or low values. It's often used to report immunogenicity results in vaccine studies.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting. It's a common and potentially serious infection, especially in older adults.
  • Vaccine efficacy (VE): A measure of how well a vaccine prevents disease in vaccinated people compared to unvaccinated people under controlled conditions, usually in a clinical trial.

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/
  4. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  5. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/
  6. http://clinicaltrials.eu/trial-id/2022-503144-40-00