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Pneumococcal Polysaccharide Serotype 15B

This article summarizes several clinical trials investigating the use of Pneumococcal Polysaccharide Serotype 15B as a component in pneumococcal vaccines. These trials aim to evaluate the safety, efficacy, and immune responses to vaccines containing this serotype, which is important for preventing pneumococcal disease in various populations.

Table of Contents

What is the pneumococcal polysaccharide serotype 15B vaccine?

The pneumococcal polysaccharide serotype 15B vaccine is a component of broader pneumococcal vaccines designed to protect against infections caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. This particular serotype (15B) is one of many strains of pneumococcus that can cause serious illnesses.[1]

Pneumococcal vaccines containing the 15B serotype are typically part of multi-valent vaccines, meaning they protect against multiple serotypes of pneumococcus. For example, it may be included in 20-valent pneumococcal conjugate vaccines (PCVs) that provide protection against 20 different pneumococcal serotypes.[2]

How does it work?

The vaccine works by introducing a small amount of the outer coating (polysaccharide) of the pneumococcus bacteria into your body. This coating is specific to the 15B serotype. Your immune system recognizes this as foreign and produces antibodies against it. If you’re later exposed to the actual 15B pneumococcus bacteria, your body can quickly recognize it and fight it off before it causes illness.[1]

In conjugate vaccines, the polysaccharide is chemically linked (conjugated) to a carrier protein. This helps make the vaccine more effective, especially in young children whose immune systems are still developing.[2]

Who should get this vaccine?

Pneumococcal vaccines containing the 15B serotype are typically recommended for:

  • Adults aged 65 years and older
  • Children and adults with certain medical conditions that increase their risk of pneumococcal disease
  • People with weakened immune systems

The exact recommendations may vary depending on the specific vaccine formulation and local health guidelines.[3]

How is it administered?

The vaccine is typically given as an injection into the muscle (intramuscular injection). For adults, it’s usually injected into the upper arm. The standard dose is 0.5 ml. Depending on the specific vaccine and a person’s risk factors, one or more doses may be recommended.[2]

How effective is it?

The effectiveness of pneumococcal vaccines containing the 15B serotype is typically evaluated as part of the overall effectiveness of the multi-valent vaccine. Studies have shown that these vaccines can significantly reduce the risk of invasive pneumococcal disease caused by the included serotypes.[3]

For example, one study found that a 20-valent pneumococcal conjugate vaccine (which includes serotype 15B) produced robust immune responses against all 20 serotypes in adults aged 60 and older.[3]

Is it safe?

Pneumococcal vaccines, including those containing the 15B serotype, are generally considered safe. Like all vaccines, they can cause side effects, but serious reactions are rare. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Fatigue
  • Muscle aches

These side effects are usually mild and resolve on their own within a few days.[3]

Ongoing research

Researchers continue to study pneumococcal vaccines to improve their effectiveness and expand their coverage. For example, one ongoing study is evaluating the safety and immune response of a new 20-valent pneumococcal conjugate vaccine (which includes serotype 15B) in adults aged 60 years and older.[3]

Another study is looking at the effectiveness of this vaccine against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older.[4]

These ongoing studies help ensure that pneumococcal vaccines, including those protecting against serotype 15B, continue to provide optimal protection against pneumococcal diseases.

Aspect Details
Vaccine Compositions Multiple pneumococcal vaccines containing serotype 15B, often combined with other serotypes (e.g., 20-valent vaccines)
Study Populations Varied, including healthy adults, older adults (60+ years), and at-risk children and adolescents
Primary Objectives Evaluate safety, tolerability, immunogenicity, and in some cases, effectiveness against pneumococcal disease
Key Outcome Measures Adverse events, opsonophagocytic activity (OPA), antibody titers, seroconversion rates
Administration Typically intramuscular injection, with some studies exploring co-administration with other vaccines
Trial Designs Randomized, controlled, often multi-center studies; some open-label and some double-blind
Follow-up Periods Varied, ranging from 30 days post-vaccination to several months or years for long-term studies

FAQ

  • What is Pneumococcal Polysaccharide Serotype 15B? Pneumococcal Polysaccharide Serotype 15B is a specific type of bacterial capsule component found in some strains of Streptococcus pneumoniae. It is used as one of the ingredients in certain pneumococcal vaccines to help protect against infections caused by this particular strain.
  • Why is this serotype being studied in clinical trials? This serotype is being studied to evaluate its effectiveness as part of pneumococcal vaccines in preventing pneumococcal diseases, assess immune responses it generates, and ensure its safety when included in vaccine formulations for different age groups and populations.
  • What types of participants are involved in these trials? The trials involve various groups, including healthy adults, older adults (aged 60 and above), and children and adolescents with increased risk of pneumococcal disease. Some studies focus on specific age ranges or risk factors.
  • What are the main outcomes being measured in these trials? The main outcomes include safety assessments (adverse events), immune responses (such as antibody levels and opsonophagocytic activity), and in some cases, the vaccine's effectiveness in preventing pneumococcal diseases.
  • How is the vaccine administered in these trials? The vaccines are typically administered as intramuscular injections. Some trials compare different dosing schedules or co-administration with other vaccines like those for respiratory syncytial virus (RSV).

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 15B

  • 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 that can be identified by laboratory tests.
  • Pneumococcal disease: Infections caused by the bacterium Streptococcus pneumoniae, which can lead to conditions such as pneumonia, meningitis, and bloodstream infections.
  • Opsonophagocytic activity (OPA): A laboratory measure of antibody function that indicates how well antibodies help immune cells engulf and destroy bacteria.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Geometric mean titer (GMT): A way of averaging antibody levels in a group of people, useful for comparing immune responses between different groups or over time.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) with a strong antigen to create a more powerful immune response, especially in young children.
  • Polysaccharide: A complex carbohydrate made up of many sugar molecules bonded together, often found on the surface of bacteria and used in some vaccines.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response.
  • Adjuvant: A substance added to a vaccine to enhance the body's immune response to the vaccine.

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/2022-503144-40-00
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/