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Pneumococcal Polysaccharide Serotype 4

This article summarizes several clinical trials investigating the safety and immunogenicity of pneumococcal vaccines containing serotype 4 polysaccharide. The studies evaluate different formulations in various populations, including healthy adults, children, and those at increased risk of pneumococcal disease. Key outcomes assessed include adverse events, antibody responses, and comparison to existing pneumococcal vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 4 vaccine?

The pneumococcal polysaccharide serotype 4 vaccine is a component of several pneumococcal vaccines used to prevent infections caused by the Streptococcus pneumoniae bacteria, specifically the serotype 4 strain. This vaccine helps protect against diseases like pneumonia, meningitis, and bloodstream infections caused by this particular strain of pneumococcus.[1]

The serotype 4 component is included in conjugate vaccines like Prevnar 13 and Apexxnar, as well as the 23-valent polysaccharide vaccine Pneumovax 23. These vaccines contain multiple pneumococcal serotypes to provide broad protection against the most common disease-causing strains.[1]

How does the vaccine work?

The vaccine works by stimulating the immune system to produce antibodies against the polysaccharide coating of the pneumococcal serotype 4 bacteria. When conjugated to a carrier protein like CRM197, it produces an even stronger immune response.

Specifically, the vaccine triggers the production of opsonophagocytic antibodies. These antibodies coat the bacteria, making them easier for immune cells to recognize and destroy if you’re exposed to the serotype 4 pneumococcus in the future.[1]

Who should get vaccinated?

Pneumococcal vaccines containing the serotype 4 component are recommended for:

  • All children under 2 years old
  • Adults 65 years and older
  • People with certain medical conditions that increase risk of pneumococcal disease, including:
    • Chronic heart, lung, liver or kidney disease
    • Diabetes
    • Weakened immune systems

The specific vaccine and schedule may vary based on age and risk factors. Your doctor can advise on the appropriate pneumococcal vaccine for your situation.[2]

How is the vaccine administered?

The pneumococcal vaccines containing serotype 4 are given as an injection, typically in the muscle of the upper arm or thigh. For most people, a single dose is sufficient. However, some high-risk groups may need additional doses or boosters.

The vaccine is often given as a series for infants, with doses at 2, 4, 6 and 12-15 months of age. Adults generally receive a single dose, with some getting a booster later in life if recommended by their doctor.[3]

Safety and side effects

Pneumococcal vaccines containing the serotype 4 component are generally very safe. The most common side effects are mild and include:

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

Serious allergic reactions are rare but possible. Seek medical attention if you experience difficulty breathing, rapid heartbeat, dizziness or severe swelling after vaccination.[2]

Effectiveness of the vaccine

Studies have shown that pneumococcal conjugate vaccines containing serotype 4 are highly effective at preventing invasive pneumococcal disease caused by this strain. The effectiveness can range from 80% to over 90% in preventing serotype 4-specific disease in vaccinated individuals.

The vaccine also helps reduce nasopharyngeal carriage of the bacteria, which can help decrease transmission in the community. This contributes to “herd immunity,” indirectly protecting unvaccinated individuals as well.[4]

Ongoing research

Researchers continue to study pneumococcal vaccines to improve their effectiveness and expand protection. Some areas of ongoing research include:

  • Developing vaccines that cover more serotypes
  • Improving immune responses in high-risk groups
  • Studying long-term effectiveness and the potential need for boosters
  • Evaluating the impact on antibiotic resistance

For example, one recent study examined the safety and immune response of a new 20-valent pneumococcal conjugate vaccine (which includes serotype 4) in adults aged 60 and older. The researchers found that the vaccine produced a strong immune response and had an acceptable safety profile.[5]

As research continues, recommendations for pneumococcal vaccination may be updated to provide the best protection against pneumococcal disease, including infections caused by serotype 4.

Study Focus Population Key Outcomes Vaccine Comparisons
Lymph node immune response Healthy adults 20-40 years Germinal center B cell frequency, T follicular helper cell frequency N/A (single arm study)
Co-administration with RSV vaccine Adults ≥60 years Safety, OPA titers, IgG concentrations PCV20 alone vs. PCV20 + RSV vaccine
Safety and immunogenicity in at-risk adults Adults 18-64 years with risk conditions Adverse events, OPA titers, IgG concentrations V116 vs. PCV15 + PPSV23
Safety and immunogenicity in older adults Adults ≥50 years Adverse events, OPA titers, IgG concentrations V116 vs. PPSV23
Monovalent vaccine in toddlers Children 11-15 months Safety, IgG concentrations, OPA titers Monovalent candidate after PCV10 primary series
Safety and immunogenicity in at-risk children/adolescents Children/adolescents with risk conditions Adverse events, OPA titers, IgG concentrations V116 vs. PPSV23

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety and immune responses generated by pneumococcal vaccines containing serotype 4, often comparing new formulations to existing vaccines in different populations.
  • Who are the typical participants in these studies? Participants vary across studies but include healthy adults, children/adolescents, older adults, and those with increased risk of pneumococcal disease due to conditions like diabetes, lung disease, or heart disease.
  • What are the key outcomes measured? Key outcomes include safety measures like injection site reactions and systemic side effects, as well as immunogenicity measures such as antibody levels and opsonophagocytic activity against pneumococcal serotypes.
  • How do these trials compare different pneumococcal vaccines? Many trials compare new vaccine candidates to existing pneumococcal vaccines like PPSV23 or PCV13, looking at safety profiles and immune responses to determine if the new vaccines are non-inferior or potentially superior.
  • What is the significance of studying pneumococcal serotype 4? Serotype 4 is one of the common pneumococcal strains that can cause invasive disease. Including it in vaccines aims to provide protection against this specific serotype as part of broader coverage against multiple strains.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 4

  • 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: The sugar coating on the outside of pneumococcal bacteria that is used in vaccines to stimulate an immune response
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcus
  • Opsonophagocytic activity (OPA): A measure of antibody function, indicating 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 across a group of people that accounts for wide ranges in individual responses
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment or procedure
  • Non-inferior: In vaccine studies, demonstrating that a new vaccine is not worse than an existing vaccine by a pre-specified margin
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to elicit a stronger immune response
  • PPSV23: 23-valent pneumococcal polysaccharide vaccine, covering 23 different pneumococcal serotypes
  • PCV13: 13-valent pneumococcal conjugate vaccine, covering 13 different pneumococcal serotypes
  • Immunoglobulin G (IgG): The most common type of antibody found in blood and other body fluids, playing a crucial role in antibody-mediated immunity

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/2023-505154-18-00
  4. http://clinicaltrials.eu/trial-id/2022-503144-40-00
  5. http://clinicaltrials.eu/trial-id/2022-501988-40-00