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Pneumococcal Polysaccharide Serotype 8 Conjugated To Crm197

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 8 conjugated to CRM197, a component of pneumococcal conjugate vaccines. These trials aim to evaluate the safety, immune response, and effectiveness of new pneumococcal vaccines containing this serotype, particularly in adults and at-risk populations. The studies examine various aspects including optimal vaccination timing, co-administration with other vaccines, and protection against pneumococcal disease.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 8 Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 8 Conjugated to CRM197 is a component of certain pneumococcal vaccines. It is designed to protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the serotype 8 strain[1]. This component is part of a larger group of similar substances that target different serotypes of the pneumococcal bacteria.

How Does it Work?

This vaccine component works by stimulating the body’s immune system to produce antibodies against the serotype 8 pneumococcal bacteria. The polysaccharide (a type of sugar molecule) from the bacterial coating is attached (conjugated) to a carrier protein called CRM197. This combination helps the immune system recognize and respond more effectively to the bacteria, providing protection against future infections[1].

Part of Which Vaccine?

Pneumococcal Polysaccharide Serotype 8 Conjugated to CRM197 is one of the components in the 20-valent pneumococcal conjugate vaccine, also known as Apexxnar or PCV20. This vaccine includes 20 different serotypes of pneumococcal bacteria, providing broad protection against various strains[2].

Who is it For?

The vaccine containing this component is typically recommended for:

  • Adults aged 65 years and older
  • Adults aged 18-64 with certain risk factors or medical conditions that increase their risk of pneumococcal disease
  • Children and adolescents with increased risk of pneumococcal disease
Specific recommendations may vary depending on individual health status and previous vaccination history[3].

How is it Administered?

The vaccine is typically given as an intramuscular injection, usually in the upper arm or thigh. For most adults, a single 0.5 ml dose is recommended. The exact dosing schedule may vary depending on age, risk factors, and previous vaccination history[2].

Effectiveness

Clinical trials have shown that vaccines containing this component are effective in stimulating an immune response against serotype 8 pneumococcal bacteria. The effectiveness is typically measured by looking at the levels of antibodies produced and their ability to kill the bacteria (opsonophagocytic activity). Studies have shown significant increases in these measures after vaccination[4].

Safety and Side Effects

Vaccines containing this component have generally been found to be safe and well-tolerated. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain
Serious side effects are rare. As with any vaccine, there is a small risk of allergic reaction[3].

Ongoing Research

Research is ongoing to further evaluate the effectiveness and safety of vaccines containing this component. Current studies are looking at:

  • Long-term protection provided by the vaccine
  • Effectiveness in different age groups and populations
  • Potential for preventing pneumococcal disease in high-risk individuals
  • Comparison with other pneumococcal vaccines
These studies will help to refine vaccination strategies and improve protection against pneumococcal disease[5].

Trial Focus Key Objectives Target Population Main Outcomes
Lymph node immune response Study vaccine-induced immunity in lymph nodes Healthy adults 20-40 years old Germinal center B cell frequency, T follicular helper cell frequency
Co-administration with RSV vaccine Evaluate safety and immune response when co-administered Adults ≥60 years old Opsonophagocytic antibody titers, adverse events
Safety and immunogenicity in at-risk adults Assess safety and immune response in high-risk groups Adults 18-64 years with risk conditions Adverse events, opsonophagocytic activity, IgG concentrations
Comparison to PPSV23 in older adults Compare immune response to existing vaccine Adults ≥50 years old Opsonophagocytic activity, IgG levels, adverse events
Safety and immunogenicity in at-risk youth Evaluate in children/adolescents with risk factors Children/adolescents with increased risk Adverse events, opsonophagocytic activity, IgG concentrations
Effectiveness against pneumonia Assess protection against community-acquired pneumonia Adults ≥65 years old Vaccine effectiveness against radiologically-confirmed pneumonia

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 8 conjugated to CRM197, particularly in adults and at-risk populations.
  • Who are the target populations for these vaccine trials? The trials target various adult populations, including healthy adults aged 50 and older, adults aged 60 and older, adults with increased risk factors for pneumococcal disease, and in some cases, children and adolescents at higher risk.
  • What are some of the key outcomes being measured? Key outcomes include the percentage of participants with adverse events, antibody responses measured by opsonophagocytic activity (OPA) and immunoglobulin G (IgG) levels, and in some trials, the vaccine's effectiveness against pneumococcal pneumonia.
  • Are these vaccines being compared to existing pneumococcal vaccines? Yes, some trials compare the new vaccines to existing pneumococcal vaccines like PPSV23 (23-valent pneumococcal polysaccharide vaccine) or evaluate them as follow-up to previous pneumococcal vaccinations.
  • What is unique about the pneumococcal serotype 8 in these vaccines? Serotype 8 is one of the additional serotypes included in newer pneumococcal conjugate vaccines to provide broader protection against pneumococcal disease. Its inclusion aims to address serotypes not covered by earlier conjugate vaccines.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 8 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

  • Pneumococcal polysaccharide: A sugar molecule found on the surface of pneumococcal bacteria that helps trigger an immune response when used in a vaccine.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein 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 pneumococcal bacteria identified by their surface polysaccharides.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a stronger antigen (like a protein) to improve the immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation that plays a crucial role in antibody-mediated immunity against invading pathogens.
  • 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.
  • PPSV23: 23-valent pneumococcal polysaccharide vaccine, an older type of pneumococcal vaccine that contains purified polysaccharides from 23 types of pneumococcal bacteria.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by pneumococcal bacteria among other pathogens.

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-id/2022-503144-40-00
  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/