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Pneumococcal Polysaccharide Serotype 18C

This article summarizes clinical trials investigating the use of pneumococcal polysaccharide serotype 18C conjugate vaccine. These trials aim to evaluate the safety, tolerability, and immunogenicity of various pneumococcal conjugate vaccine formulations containing serotype 18C in different populations. The studies examine immune responses, adverse events, and compare different dosing schedules and co-administration with other vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 18C vaccine?

The pneumococcal polysaccharide serotype 18C vaccine is a component of vaccines that help protect against infections caused by the bacteria Streptococcus pneumoniae, also known as pneumococcus. This specific serotype (18C) is one of many pneumococcal strains that can cause serious illnesses.[1]

This vaccine contains purified portions of the outer coating (polysaccharide) of the pneumococcal bacteria. It is usually combined with other serotypes in multi-valent pneumococcal vaccines to provide broader protection against pneumococcal diseases.

How does it work?

The vaccine works by stimulating your immune system to produce antibodies against the pneumococcal bacteria. Specifically, it triggers an immune response to the outer coating of the serotype 18C pneumococcus. When you’re later exposed to this bacteria, your body recognizes it and can fight off the infection more effectively.[2]

In many pneumococcal vaccines, the polysaccharide is conjugated (chemically linked) to a protein carrier. This process enhances the immune response, especially in young children. Common protein carriers include CRM197, which is a non-toxic variant of diphtheria toxin.

Who needs this vaccine?

Pneumococcal vaccines containing the 18C serotype are recommended for:

  • Infants and young children as part of their routine vaccination schedule
  • Adults 65 years and older
  • People with certain medical conditions that increase their risk of pneumococcal disease, such as:
    • Chronic heart, lung, or liver disease
    • Diabetes
    • Weakened immune systems

The specific recommendations may vary by country and the type of pneumococcal vaccine used.[3]

How is it administered?

The pneumococcal vaccine containing serotype 18C is typically given as an injection into the muscle (intramuscular injection). For infants, it’s often administered in the thigh, while for older children and adults, it’s usually given in the upper arm.

The number of doses and schedule can vary depending on the specific vaccine and the age at which vaccination begins. For example, infants might receive multiple doses as part of their primary vaccination series, while adults might only need a single dose.[4]

Safety and side effects

Pneumococcal vaccines, including those containing the 18C serotype, are generally considered safe and well-tolerated. However, like all vaccines, they can cause some side effects. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability (in young children)
  • Fatigue
  • Headache

Serious side effects are rare but can include severe allergic reactions. It’s important to discuss any concerns or medical conditions with your healthcare provider before receiving the vaccine.[5]

Effectiveness

Vaccines containing the pneumococcal polysaccharide serotype 18C have been shown to be effective in reducing the incidence of invasive pneumococcal disease caused by this specific strain. The effectiveness can vary depending on factors such as age, overall health, and the specific vaccine formulation used.

Studies have demonstrated that conjugate vaccines, which include serotype 18C, are particularly effective in young children, dramatically reducing rates of invasive pneumococcal disease.[2]

Ongoing research

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

  • Developing vaccines that cover more serotypes
  • Studying the long-term effectiveness of current vaccines
  • Investigating the impact of vaccination programs on pneumococcal disease rates in different populations
  • Exploring new vaccine technologies and delivery methods

For example, one study is evaluating the safety and immune response of a new pneumococcal conjugate vaccine candidate in toddlers who previously received a different pneumococcal vaccine.[6]

As research progresses, recommendations for pneumococcal vaccination may be updated to provide the best protection against pneumococcal diseases, including those caused by serotype 18C.

Trial Characteristic Details
Populations studied Healthy infants and toddlers, children and adolescents at increased risk for pneumococcal disease, healthy adults aged 60+
Vaccine formulations Various pneumococcal conjugate vaccines containing serotype 18C (e.g. V116, PCV20, investigational monovalent pneumococcal conjugate candidate)
Primary outcomes Safety (adverse events), tolerability, immunogenicity (antibody responses)
Secondary outcomes Comparison of immune responses between vaccines/schedules, functional antibody activity (OPA)
Safety assessments Local injection site reactions, systemic adverse events, serious adverse events
Immunogenicity measures IgG antibody concentrations, opsonophagocytic activity titers, geometric mean titers, proportions with ≥4-fold rise in antibody levels
Comparator vaccines PPSV23, PCV15, licensed pneumococcal conjugate vaccines

FAQ

  • What is the purpose of these clinical trials? The main purposes are to evaluate the safety, tolerability, and immunogenicity of pneumococcal conjugate vaccines containing serotype 18C in different populations such as infants, children, and adults.
  • What populations are being studied? The trials involve various populations including healthy infants and toddlers, children and adolescents at increased risk for pneumococcal disease, and healthy adults aged 60 years and older.
  • What are the main outcomes being measured? Key outcomes include immune responses (antibody levels), rates of adverse events, tolerability, and comparisons of immune responses between different vaccine formulations or dosing schedules.
  • Are there any comparisons to existing vaccines? Yes, some trials compare the investigational vaccines to licensed pneumococcal vaccines like PPSV23 or examine co-administration with other routine vaccines.
  • How is the safety of the vaccines being evaluated? Safety is assessed by monitoring for local injection site reactions, systemic adverse events, and serious adverse events following vaccination.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 18C

  • 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 antigens on the cell surface. For pneumococcus, different 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.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of antibody function that assesses the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells.
  • Geometric mean titer (GMT): A measure of average antibody levels in a group, calculated using the geometric mean to reduce the impact of extremely high or low values.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability, or is otherwise medically significant.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation that plays a crucial role in antibody-mediated immunity against invading pathogens.
  • Pneumococcal polysaccharide vaccine (PPSV23): A vaccine containing purified polysaccharides from 23 different serotypes of Streptococcus pneumoniae, used primarily in older adults and high-risk groups.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response, especially in young children.

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/2023-504625-39-00
  6. http://clinicaltrials.eu/trial-id/2023-505154-18-00