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Pneumococcal Polysaccharide Serotype 10A Conjugated To Crm197

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 10A conjugated to CRM197 as part of multi-valent pneumococcal conjugate vaccines. These trials aim to evaluate the safety, immune response, and effectiveness of these vaccines in preventing pneumococcal disease in various populations, including healthy adults, older adults, and individuals at increased risk. The studies examine factors like antibody levels, opsonophagocytic activity, and vaccine efficacy against pneumonia and other pneumococcal infections.

Table of Contents

What is PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197?

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 is a component of a pneumococcal vaccine designed to protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 10A serotype. This vaccine ingredient is part of a larger group of pneumococcal vaccines known as conjugate vaccines.[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the pneumococcal bacteria. The polysaccharide (a type of sugar molecule) from the bacterial coating is attached (conjugated) to a carrier protein called CRM197. This conjugation enhances the immune response, especially in young children and older adults whose immune systems might not respond as strongly to the polysaccharide alone.[2]

What diseases does it treat?

This vaccine component, as part of a larger pneumococcal vaccine, helps prevent diseases caused by Streptococcus pneumoniae, including:

  • Pneumonia (lung infection)
  • Bacteremia (blood infection)
  • Meningitis (infection of the membranes covering the brain and spinal cord)
  • Otitis media (middle ear infection)

These infections can be particularly serious in young children, older adults, and people with weakened immune systems.[1][3]

Vaccine composition

The PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 is typically part of a multi-valent vaccine, meaning it protects against multiple serotypes of pneumococcal bacteria. For example, it may be included in vaccines such as the 20-valent pneumococcal conjugate vaccine (20vPnC) or the 21-valent pneumococcal conjugate vaccine (V116).[3][4]

How is it administered?

The vaccine containing this component is usually administered as an intramuscular injection. The specific dosing schedule may vary depending on the age of the recipient and their previous vaccination history. Typically, a single 0.5 ml dose is given.[3][4]

Clinical trials and research

Several clinical trials have been conducted or are ongoing to evaluate the safety and efficacy of pneumococcal vaccines containing this component. For example:

  • A Phase 3 study is evaluating the safety, tolerability, and immunogenicity of V116 (a 21-valent pneumococcal conjugate vaccine) in adults aged 18 to 64 years with increased risk for pneumococcal disease.[4]
  • Another Phase 3 study is assessing the safety and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age or older.[5]

Safety and efficacy

Clinical trials are designed to evaluate the safety and efficacy of vaccines containing this component. Key measures include:

  • The percentage of participants experiencing adverse events
  • The immune response, measured by opsonophagocytic activity (OPA) and immunoglobulin G (IgG) levels
  • The proportion of participants achieving a significant increase in antibody levels

These studies help ensure that the vaccine is both safe and effective in preventing pneumococcal infections.[4][5]

Who should receive this vaccine?

Pneumococcal vaccines containing this component are typically recommended for:

  • Adults aged 65 years and older
  • Adults aged 18-64 with certain chronic medical conditions or risk factors
  • Children, particularly those under 2 years old (as part of a different formulation)

However, the specific recommendations may vary depending on the particular vaccine formulation and local health guidelines.[3][4]

Potential side effects

As with any vaccine, there may be some side effects. Common side effects of pneumococcal vaccines may include:

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

Serious side effects are rare but can occur. It’s important to discuss any concerns with your healthcare provider.[3][4]

Conclusion

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 is an important component of modern pneumococcal vaccines. As part of these vaccines, it helps protect against serious infections caused by Streptococcus pneumoniae bacteria. Ongoing research continues to refine and improve these vaccines to provide better protection for vulnerable populations. If you have questions about whether you should receive a pneumococcal vaccine, consult with your healthcare provider.

Trial ID Population Intervention Primary Outcomes
2022-501519-15-00 Healthy adults 20-40 years old Pneumococcal conjugate vaccine (20-valent) Germinal center B cell frequency in lymph node aspirates
2022-501988-40-00 Adults 18-64 years at increased risk for pneumococcal disease V116 vaccine vs PCV15 + PPSV23 Safety, tolerability, and OPA GMTs
2022-503144-40-00 Adults 50 years and older V116 vaccine vs PPSV23 Safety, tolerability, and OPA GMTs
2023-506236-32-00 Children and adolescents at increased risk for pneumococcal disease V116 vaccine vs PPSV23 Safety, tolerability, and OPA GMTs
2023-507293-40-00 Adults 65 years and older 20-valent pneumococcal conjugate vaccine Vaccine effectiveness against radiologically-confirmed CAP

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immune response, and effectiveness of pneumococcal conjugate vaccines containing serotype 10A in preventing pneumococcal disease in different populations.
  • Who are the target populations for these vaccine trials? The trials target various groups including healthy adults, adults 50 years and older, adults 60 years and older, and children/adolescents at increased risk for pneumococcal disease.
  • What are some of the key outcomes being measured? Key outcomes include antibody levels, opsonophagocytic activity (OPA), adverse events, and vaccine efficacy against pneumonia and other pneumococcal infections.
  • How is the immune response to the vaccine typically measured? The immune response is typically measured through blood tests looking at antibody levels (IgG) and functional antibody activity (OPA) against the vaccine serotypes.
  • What is meant by 'conjugate' vaccine in this context? A conjugate vaccine links the pneumococcal polysaccharides to a carrier protein (CRM197 in this case) to enhance the immune response, especially in young children and older adults.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 10A 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

    3 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

    3 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

    3 1 1 1
    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

    3 1 1
    Investigated drugs:
    Poland

Glossary

  • Pneumococcal disease: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, meningitis, and bloodstream infections.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of Streptococcus pneumoniae.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function, indicating how well antibodies help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody in blood that helps protect against bacterial and viral infections.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people, useful for comparing immune responses.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Vaccine efficacy: A measure of how well a vaccine prevents disease in vaccinated people compared to unvaccinated people.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to increase the immune response.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by Streptococcus pneumoniae.

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-id/2022-503144-40-00