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Pneumococcal Polysaccharide Serotype 11A Conjugated To Crm197

This article summarizes clinical trials investigating pneumococcal vaccines containing the serotype 11A polysaccharide conjugated to CRM197. These trials aim to evaluate the safety, immunogenicity, and effectiveness of new pneumococcal conjugate vaccines in various age groups and populations. The studies examine immune responses, adverse events, and protection against pneumococcal disease provided by vaccines containing this and other pneumococcal serotypes.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 11A Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 11A Conjugated to CRM197 is a component of pneumococcal vaccines designed to prevent diseases caused by the Streptococcus pneumoniae bacteria, specifically the 11A serotype. This component is part of newer, more comprehensive pneumococcal vaccines that aim to provide broader protection against various strains of pneumococcal bacteria.[1]

How Does it Work?

The vaccine works by stimulating the immune system to produce antibodies against the pneumococcal bacteria. The 11A serotype is one of many strains included in the vaccine. By conjugating (attaching) the bacterial polysaccharide to a carrier protein called CRM197, the vaccine can elicit a stronger immune response, especially in young children and older adults whose immune systems might not respond as well to the polysaccharide alone.[1]

Vaccine Composition

This component is typically part of multi-valent pneumococcal conjugate vaccines. For example, it is included in the 20-valent pneumococcal conjugate vaccine (20vPnC) known as Apexxnar. The vaccine contains 20 different pneumococcal serotypes, each conjugated to CRM197 and adsorbed on aluminum phosphate to enhance the immune response.[2]

Who is the Vaccine For?

Pneumococcal vaccines containing this component are generally intended for:

  • Adults aged 65 years and older
  • Adults aged 18-64 with certain risk factors or medical conditions
  • Children and adolescents at increased risk of pneumococcal disease
The specific indications may vary depending on the particular vaccine formulation and local health guidelines.[3]

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:

  • A Phase 3 study is evaluating the vaccine in adults aged 65 years or older to determine its effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia.[4]
  • Another Phase 3 trial is assessing the safety and immune response in adults aged 50 years or older.[5]
  • A study is investigating the vaccine’s safety and immunogenicity in children and adolescents with increased risk for pneumococcal disease.[6]

Safety and Efficacy

Clinical trials are evaluating various aspects of safety and efficacy, including:

  • The percentage of participants experiencing adverse events after vaccination
  • The immune response measured by opsonophagocytic activity (OPA) and antibody levels
  • The proportion of participants achieving a significant rise in antibody levels
  • The vaccine’s effectiveness in preventing pneumococcal disease in real-world settings
Preliminary results suggest that the vaccine is generally well-tolerated and capable of inducing an immune response against the included serotypes, including 11A.[5]

Administration

The vaccine is typically administered as an intramuscular injection. The dosing schedule may vary depending on the specific vaccine formulation and the patient’s age and risk factors. For adults, it is often given as a single 0.5 ml dose. In some cases, it may be co-administered with other vaccines, such as the influenza vaccine.[2]

As with any vaccine, it’s important to consult with a healthcare provider to determine if this pneumococcal vaccine is appropriate for you or your child, considering individual health status and risk factors.

Trial ID Population Intervention Key Outcomes
2022-501519-15-00 Healthy adults 20-40 years old Pneumococcal vaccination and lymph node fine needle aspiration Germinal center B cell frequency, T follicular helper cell frequency, B and T cell phenotypes
2022-501988-40-00 Adults 60+ years old 20-valent pneumococcal conjugate vaccine (PCV20) with RSV vaccine Opsonophagocytic activity titers, adverse events
2022-502791-22-01 Adults 18-64 years at increased risk 21-valent pneumococcal conjugate vaccine (V116) Opsonophagocytic activity titers, adverse events
2022-503144-40-00 Adults 50+ years old 21-valent pneumococcal conjugate vaccine (V116) Opsonophagocytic activity titers, IgG levels, adverse events
2023-506236-32-00 Children/adolescents at increased risk 21-valent pneumococcal conjugate vaccine (V116) Opsonophagocytic activity titers, IgG levels, adverse events
2023-507293-40-00 Adults 65+ years old 20-valent pneumococcal conjugate vaccine (PCV20) Vaccine effectiveness against community-acquired pneumonia

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immunogenicity, and effectiveness of pneumococcal conjugate vaccines containing serotype 11A and other serotypes in different populations.
  • What 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 immune responses (antibody levels), rates of adverse events, and vaccine effectiveness against pneumococcal disease like pneumonia.
  • How is the immune response to the vaccines being assessed? Immune response is being assessed through measurements like opsonophagocytic activity (OPA) titers and immunoglobulin G (IgG) levels specific to the vaccine serotypes.
  • 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 evaluate relative immunogenicity and effectiveness.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 11A 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 polysaccharide: A sugar molecule found on the surface of pneumococcus bacteria that helps trigger an immune response. Different serotypes have different polysaccharides.
  • CRM197: A non-toxic variant of diphtheria toxin used as a protein carrier in conjugate vaccines to enhance the immune response, especially in young children.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcus with unique surface polysaccharides.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a stronger antigen (like a protein carrier) to improve the immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function that assesses 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 that reduces the impact of very high or low individual values.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by bacteria like pneumococcus.

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-id/2022-502791-22-01
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/
  5. http://clinicaltrials.eu/trial-id/2022-503144-40-00
  6. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/