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Pneumococcal Polysaccharide Serotype 10A

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 10A conjugate vaccine, often as part of multi-valent pneumococcal vaccines, for preventing pneumococcal infections. The trials evaluate the safety, immune responses, and effectiveness of these vaccines in different populations, including healthy adults, children, and those at increased risk of pneumococcal disease. Key aspects examined include vaccine-induced antibody levels, opsonophagocytic activity, and protection against pneumococcal pneumonia.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 10A?

Pneumococcal Polysaccharide Serotype 10A is a specific type of bacterial capsule component found in certain strains of Streptococcus pneumoniae, also known as pneumococcus. This bacterium is responsible for various infections, including pneumonia, meningitis, and bloodstream infections. Serotype 10A refers to one of the many variants of the pneumococcal bacteria, each with a unique polysaccharide coating that helps it evade the immune system.[1]

Role in Pneumococcal Vaccines

Pneumococcal Polysaccharide Serotype 10A plays a crucial role in modern pneumococcal vaccines. It is included as one of the serotypes targeted by advanced pneumococcal conjugate vaccines. In these vaccines, the polysaccharide is chemically linked (conjugated) to a carrier protein, typically CRM197, which enhances the immune response, especially in young children and older adults.[1]

Vaccine Formulations

Several pneumococcal vaccines containing Serotype 10A are currently in use or under development:

  • Apexxnar (20-valent pneumococcal conjugate vaccine): This vaccine includes Pneumococcal Polysaccharide Serotype 10A among its 20 serotypes, all conjugated to CRM197 and adsorbed on aluminum phosphate.[2]
  • V116 (21-valent pneumococcal conjugate vaccine): An investigational vaccine that also includes Serotype 10A among its targeted serotypes.[3]

Target Population

Pneumococcal vaccines containing Serotype 10A are primarily designed for:

  • Adults aged 65 years and older
  • Adults aged 18-64 with certain risk factors or chronic conditions
  • Children and adolescents at increased risk of pneumococcal disease

These vaccines aim to protect against invasive pneumococcal disease (IPD) and community-acquired pneumonia (CAP) caused by the vaccine serotypes, including Serotype 10A.[4]

Effectiveness and Immune Response

The effectiveness of vaccines containing Pneumococcal Polysaccharide Serotype 10A is typically measured through:

  • Opsonophagocytic activity (OPA): This measures the ability of antibodies to facilitate the killing of bacteria by immune cells.
  • Immunoglobulin G (IgG) levels: These indicate the concentration of specific antibodies produced against the serotype.

Clinical trials have shown that vaccines containing Serotype 10A can elicit a significant immune response, with many participants achieving a four-fold or greater rise in OPA titers and IgG concentrations after vaccination.[5]

Safety Profile

The safety of pneumococcal vaccines containing Serotype 10A is closely monitored in clinical trials. Common side effects may include:

  • Injection site reactions (pain, redness, swelling)
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain

Serious adverse events are rare, and the vaccines are generally considered safe for the recommended populations.[5]

Ongoing Research

Several clinical trials are currently underway to further evaluate the effectiveness and safety of pneumococcal vaccines containing Serotype 10A:

  • Studies comparing the immune response of newer vaccines to existing ones
  • Investigations into the vaccine’s effectiveness against community-acquired pneumonia
  • Research on the vaccine’s performance in specific populations, such as those with chronic medical conditions

These ongoing studies aim to provide more comprehensive data on the role of Pneumococcal Polysaccharide Serotype 10A in preventing pneumococcal diseases across various age groups and risk categories.[4]

Aspect Details
Vaccine Types Multi-valent pneumococcal conjugate vaccines including serotype 10A (e.g. 20-valent, 21-valent)
Study Populations Healthy adults, children/adolescents at risk, adults ≥65 years
Primary Outcomes Safety, immunogenicity, opsonophagocytic activity, prevention of pneumococcal pneumonia
Key Measurements Antibody levels, OPA titers, adverse events, vaccine effectiveness
Study Designs Randomized controlled trials, open-label studies, test-negative designs
Comparators Other pneumococcal vaccines (e.g. PPSV23), placebo, or no vaccination
Follow-up Periods Ranging from 30 days post-vaccination to several months or years
Special Considerations Co-administration with other vaccines, effects in high-risk groups, long-term protection

FAQ

  • What is the main purpose of these pneumococcal vaccine clinical trials? The main purpose is to evaluate the safety, immune responses, and effectiveness of pneumococcal vaccines containing serotype 10A, often as part of multi-valent formulations, in preventing pneumococcal infections in various populations.
  • Who are the target populations for these vaccine trials? The trials target different groups, including healthy adults, children and adolescents at increased risk of pneumococcal disease, and adults aged 65 and older.
  • What are some key outcomes measured in these trials? Key outcomes include antibody levels, opsonophagocytic activity (which measures the ability of antibodies to kill bacteria), vaccine safety/adverse events, and effectiveness in preventing pneumococcal pneumonia.
  • How is the effectiveness of the vaccine measured in some trials? In some trials, effectiveness is measured by comparing rates of pneumococcal pneumonia between vaccinated and unvaccinated groups, or by examining antibody responses and opsonophagocytic activity against different pneumococcal serotypes.
  • What is unique about the pneumococcal vaccines being studied? The vaccines being studied are often multi-valent, meaning they protect against multiple pneumococcal serotypes, including serotype 10A. Some trials examine newer formulations with up to 20 or 21 serotypes, aiming to provide broader protection against pneumococcal disease.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 10A

  • 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 diseases:
    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 diseases:
    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 diseases:
    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 diseases:
    Investigated drugs:
    Denmark

Glossary

  • Pneumococcal polysaccharide serotype 10A: A specific type of pneumococcal bacteria identified by its unique surface sugar (polysaccharide) structure. It is one of the strains included in some pneumococcal vaccines to provide protection against infections caused by this particular serotype.
  • Opsonophagocytic activity (OPA): A measure of the functional ability of antibodies to facilitate the uptake and killing of bacteria by immune cells. In these trials, it's used to assess the effectiveness of the vaccine-induced immune response.
  • Conjugate vaccine: A type of vaccine where the bacterial polysaccharide is chemically linked to a protein carrier. This enhances the immune response, especially in young children, and provides longer-lasting protection.
  • Serotype: A distinct variation within a species of bacteria, identified by the specific antigens on its surface. Different pneumococcal serotypes can cause different types of infections and may require specific vaccine formulations for protection.
  • Multi-valent vaccine: A vaccine that provides protection against multiple strains or serotypes of a pathogen. In the context of these trials, it refers to pneumococcal vaccines that target multiple pneumococcal serotypes, including 10A.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting. It's a common target for prevention in pneumococcal vaccine studies, especially in older adults.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body. In these trials, it's often measured by antibody levels or opsonophagocytic activity.
  • Geometric mean titer (GMT): A measure of the average antibody level in a group of subjects, calculated using the geometric mean. It's commonly used to assess vaccine-induced immune responses.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure. In vaccine trials, monitoring adverse events is crucial for assessing safety.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a protein carrier in conjugate vaccines to enhance the immune response to polysaccharide antigens.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2023-507293-40-00
  3. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  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/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/