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Pneumococcal Polysaccharide Serotype 23F

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 23F conjugate vaccine, which is a component of various pneumococcal vaccines being studied. These trials aim to evaluate the safety, tolerability, and immune responses elicited by pneumococcal vaccines containing this serotype in different populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies examine factors like vaccine dosing, co-administration with other vaccines, and comparisons to existing pneumococcal vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 23F vaccine?

The pneumococcal polysaccharide serotype 23F vaccine is a component of pneumococcal vaccines that helps protect against infections caused by the 23F strain of Streptococcus pneumoniae bacteria. This bacteria, also known as pneumococcus, can cause serious illnesses like pneumonia, meningitis, and bloodstream infections.[1]

Serotype 23F is one of many pneumococcal strains included in vaccines like Pneumovax 23, Prevenar 13, and newer vaccines under development. These vaccines contain multiple serotypes to provide broad protection against pneumococcal disease.[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the outer coating (polysaccharide) of the 23F pneumococcal bacteria. Specifically:

  • It contains purified pieces of the bacterial polysaccharide coating
  • When injected, these polysaccharides trigger the production of antibodies
  • The antibodies can then recognize and attack 23F pneumococci if exposed in the future
  • This provides immunity and protection against infections by this strain

In conjugate vaccines, the 23F polysaccharide is chemically linked to a protein carrier. This enhances the immune response, especially in young children.[1]

Who needs this vaccine?

The pneumococcal vaccines containing serotype 23F are recommended for:

  • All adults 65 years or older
  • Children and adults with certain medical conditions that increase risk of pneumococcal disease
  • Infants and young children as part of routine childhood immunizations

Specific high-risk groups that may need pneumococcal vaccination include those with:[2]

  • Chronic heart, lung, or liver disease
  • Diabetes
  • Conditions that weaken the immune system
  • Cochlear implants
  • Cerebrospinal fluid leaks

How effective is it?

Studies have shown that pneumococcal vaccines containing the 23F serotype are effective at preventing invasive pneumococcal disease caused by this strain. In clinical trials:

  • The vaccines produced a strong antibody response against serotype 23F in both children and adults
  • Vaccination significantly reduced rates of invasive pneumococcal disease caused by serotype 23F
  • Protection lasted for at least several years in most people

However, effectiveness can vary based on age, health status, and time since vaccination. Booster doses may be needed in some high-risk groups to maintain protection.[3]

Is it safe?

Pneumococcal vaccines containing serotype 23F have been extensively studied and are considered very safe. They have been used for many years with a good safety record. However, like any medical product, side effects can occur.

The vaccines do not contain live bacteria, so they cannot cause pneumococcal disease. They are also safe for people with weakened immune systems.[2]

What are the potential side effects?

Most side effects of pneumococcal vaccines are mild and resolve on their own within a few days. Common side effects may include:

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

Serious allergic reactions are very rare but can occur. Signs of a severe allergic reaction include difficulty breathing, rapid heartbeat, dizziness, or swelling of the face and throat. Seek immediate medical attention if these occur after vaccination.[2]

How is it administered?

The pneumococcal vaccine containing serotype 23F is given as an injection, usually into the muscle of the upper arm or thigh. The specific schedule depends on the type of vaccine and the person’s age and health status:

  • For adults 65 and older, usually a single dose is recommended
  • Younger adults with certain health conditions may need one or two doses
  • For infants, multiple doses are given as part of the routine vaccination schedule
  • Some people may need booster doses

The vaccine can be given at the same time as other vaccines. Your healthcare provider can determine the appropriate vaccination schedule for you based on official recommendations.[3]

Trial Aspect Details
Vaccine Types Various pneumococcal conjugate vaccines (PCV) including 10-valent, 13-valent, 15-valent, 20-valent, and investigational monovalent formulations
Study Populations Healthy adults, children, adolescents, toddlers, and individuals at increased risk for pneumococcal disease
Primary Objectives Evaluate safety, tolerability, and immunogenicity of pneumococcal vaccines
Key Outcome Measures Adverse events, opsonophagocytic activity (OPA) titers, immunoglobulin G (IgG) levels
Study Designs Randomized, controlled, open-label or double-blind trials
Comparators Existing pneumococcal vaccines (e.g., PPSV23), co-administration with other vaccines (e.g., RSV vaccine)
Follow-up Duration Varies by study, typically 30 days to 6 months post-vaccination

FAQ

  • What is pneumococcal polysaccharide serotype 23F? Pneumococcal polysaccharide serotype 23F is one of the bacterial capsule types found on Streptococcus pneumoniae. It is included as a component in pneumococcal conjugate vaccines to help protect against infections caused by this particular strain of pneumococcus.
  • Who are the target populations for these pneumococcal vaccine trials? The trials target various populations including healthy adults, children and adolescents, toddlers, and individuals at increased risk of pneumococcal disease due to conditions like diabetes, chronic liver/lung/heart/kidney disease.
  • What are the main objectives of these clinical trials? The main objectives are to evaluate the safety, tolerability, and immunogenicity of the pneumococcal vaccines. This includes assessing adverse events, measuring antibody responses, and comparing immune responses to existing vaccines.
  • How is the immune response to the vaccines measured? The immune response is typically measured by looking at opsonophagocytic activity (OPA) titers and immunoglobulin G (IgG) levels specific to each pneumococcal serotype included in the vaccine. Researchers examine the geometric mean titers/concentrations and fold-rises in these antibodies after vaccination.
  • Are there any notable side effects or safety concerns mentioned? The trials monitor for both local injection site reactions (like pain, redness, swelling) and systemic events (like fever, fatigue). Serious adverse events are also tracked. However, no major safety concerns are highlighted in the trial summaries provided.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 23F

  • Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Pneumococcal Vaccines PCV13 and PPV23 in Adults with Acute Leukemia or Lymphoma Undergoing Chemotherapy

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on Long-Term Kidney Transplant Outcomes in Low-Risk Patients Using Tacrolimus Alone or with Mycophenolate Mofetil

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of a 21-Valent Pneumococcal Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

    Not recruiting

    3 1 1
    Investigated drugs:
    Estonia Poland

  • 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 Best Time for Influenza Vaccine Administration in Adults Aged 60-85 Using Influenza Vaccine and Drug Combination

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

    Not recruiting

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

  • Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +15

  • 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 Venetoclax and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma with Translocation (11;14)

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Serotype: A distinct variation within a species of bacteria or virus, characterized by specific surface structures. For pneumococcus, serotypes are distinguished by differences in their polysaccharide capsule.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a bacterial polysaccharide) to a stronger antigen to elicit a more robust immune response, especially in young children.
  • 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 found in blood circulation, playing a crucial role in antibody-mediated immunity against invading pathogens.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of subjects that reduces the impact of very high or low individual values.
  • 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.
  • Pneumococcal disease: Infections caused by Streptococcus pneumoniae bacteria, which can lead to conditions like pneumonia, meningitis, and bloodstream infections.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a protein carrier in conjugate vaccines to enhance the immune response.
  • Polysaccharide: A complex carbohydrate made up of multiple sugar molecules. In pneumococcal vaccines, these refer to the sugar coatings of the bacteria that are targeted by the immune system.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2022-502791-22-01
  3. http://clinicaltrials.eu/trial-id/2022-501988-40-00