#1 Clinical Trials Search in Europe

Pneumococcal Polysaccharide Serotype 3 Conjugated To Crm197

This article summarizes clinical trials investigating the use of pneumococcal polysaccharide serotype 3 conjugated to CRM197 vaccine. These trials aim to evaluate the safety, tolerability, and immune response of this vaccine component in various populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies examine different formulations and combinations of pneumococcal vaccines to determine their effectiveness in preventing pneumococcal infections.

Table of Contents

What is this vaccine?

The pneumococcal polysaccharide serotype 3 conjugate vaccine is a type of vaccine that helps protect against infections caused by a specific strain of bacteria called Streptococcus pneumoniae (pneumococcus) serotype 3. This vaccine is part of broader pneumococcal conjugate vaccines that target multiple serotypes of pneumococcus bacteria.[1]

The vaccine contains parts of the outer coating (polysaccharide) of the pneumococcus bacteria, which is chemically linked (conjugated) to a non-toxic variant of diphtheria toxin called CRM197. This conjugation helps make the vaccine more effective, especially in young children.[2]

How does it work?

When you receive this vaccine, your immune system recognizes the bacterial components as foreign and produces antibodies against them. These antibodies help your body fight off future infections from pneumococcus serotype 3 bacteria more effectively. The CRM197 protein helps boost the immune response, making the vaccine more potent and long-lasting.[1]

What diseases does it help prevent?

This vaccine specifically targets pneumococcal serotype 3, which can cause various infections, including:

  • Pneumonia – an infection of the lungs
  • Bacteremia – a blood infection
  • Meningitis – an infection of the lining of the brain and spinal cord
  • Otitis media – middle ear infections

By preventing infections from this particular strain, the vaccine helps reduce the overall burden of pneumococcal disease.[3]

Who should get this vaccine?

This vaccine is typically included as part of broader pneumococcal conjugate vaccines given to:

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

The exact recommendations may vary by country and specific vaccine formulation. Always consult with your healthcare provider to determine if this vaccine is appropriate for you or your child.[4]

How is it administered?

The vaccine is usually given as an intramuscular injection, typically in the thigh for infants or the upper arm for older children and adults. It’s often administered as part of a series of shots, with the number of doses depending on the age at which vaccination begins and individual risk factors.[1]

Safety and side effects

Pneumococcal conjugate vaccines, including those containing serotype 3, have been shown to be safe and well-tolerated. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability in young children
  • Decreased appetite
  • Fatigue

Serious side effects are rare. As with any vaccine, there is a very small risk of severe allergic reaction. If you notice any unusual symptoms after vaccination, contact your healthcare provider immediately.[5]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to improve their effectiveness and broaden protection against more serotypes. Some areas of ongoing research include:

  • Developing vaccines that cover additional pneumococcal serotypes
  • Studying the long-term effectiveness of these vaccines
  • Investigating the impact of widespread vaccination on pneumococcal disease rates
  • Exploring new methods of vaccine delivery

These studies aim to enhance our ability to prevent pneumococcal infections and reduce the global burden of these diseases.[3][4]

Aspect Details
Vaccine Types Pneumococcal conjugate vaccines (PCV) including serotype 3, V116, MenABCWY, PCV20
Study Populations Healthy adults (50+ years), children and adolescents at risk, infants, adults with specific health conditions
Primary Objectives Safety, tolerability, immunogenicity assessment
Key Measurements Adverse events, OPA titers, IgG concentrations
Comparison Vaccines PPSV23, PCV15, existing pneumococcal vaccines
Trial Phases Phase 2 and Phase 3 studies
Administration Routes Intramuscular injection
Follow-up Periods Vary by study, typically 1-6 months post-vaccination

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, tolerability, and immunogenicity (immune response) of pneumococcal vaccines containing serotype 3 polysaccharide conjugated to CRM197. The studies aim to determine how well these vaccines protect against pneumococcal infections in different populations.
  • Who are the target populations for these vaccine trials? The target populations vary across the trials but include healthy adults (aged 50 years and older), children and adolescents at increased risk of pneumococcal disease, healthy infants, and adults with specific risk conditions such as diabetes, chronic liver disease, or chronic kidney disease.
  • What are some of the key measurements used in these trials? Key measurements include the percentage of participants experiencing adverse events, opsonophagocytic activity (OPA) titers, which measure the functional antibody response, and immunoglobulin G (IgG) concentrations. These help assess both the safety and the immune response to the vaccines.
  • How do these trials compare different pneumococcal vaccines? Some trials compare new vaccine formulations (like V116 or MenABCWY) to existing vaccines such as PPSV23 or PCV20. They evaluate factors like immune response, safety profiles, and the ability to protect against various pneumococcal serotypes.
  • What is the significance of studying pneumococcal serotype 3? Pneumococcal serotype 3 is an important target for vaccination because it is associated with severe pneumococcal disease. By including this serotype in conjugate vaccines, researchers aim to improve protection against a broader range of pneumococcal infections.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 3 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 a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia Estonia Finland Germany Greece +3

  • 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 component of the bacterial cell wall of Streptococcus pneumoniae, used in vaccines to stimulate an immune response against the bacteria.
  • 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, different strains of Streptococcus pneumoniae with unique surface polysaccharides.
  • Opsonophagocytic activity (OPA): A measure of the functional antibody response that indicates how well antibodies can help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody in blood and other body fluids, playing a crucial role in the immune response against pathogens.
  • Geometric mean titer (GMT): A way of averaging antibody levels in a group of people, useful for comparing immune responses between different vaccines or populations.
  • Adverse event (AE): 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.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen with a strong antigen to increase the immune response, especially effective in young children.
  • Invasive pneumococcal disease (IPD): A severe infection caused by Streptococcus pneumoniae bacteria in normally sterile sites like blood or cerebrospinal fluid.

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-id/2023-505154-18-00