#1 Clinical Trials Search in Europe

Pneumococcal Polysaccharide Serotype 1

This article summarizes several clinical trials investigating the safety and immunogenicity of pneumococcal vaccines containing polysaccharide serotype 1, including studies in adults, children, and those at increased risk for pneumococcal disease. The trials evaluate different formulations and combinations of pneumococcal vaccines to determine their effectiveness in producing an immune response and their safety profiles in various populations.

Table of Contents

What is the pneumococcal polysaccharide serotype 1 vaccine?

The pneumococcal polysaccharide serotype 1 vaccine is a component of several pneumococcal vaccines that help protect against infections caused by the Streptococcus pneumoniae bacteria, also known as pneumococcus.[1] This particular serotype (type 1) is one of many pneumococcal strains that can cause serious illnesses like pneumonia, meningitis, and bloodstream infections.

The vaccine contains purified polysaccharides (complex sugar molecules) from the outer coating of the pneumococcal bacteria. These polysaccharides are conjugated (chemically linked) to a carrier protein, which helps improve the immune response, especially in young children.[1]

How does it work?

When you receive the vaccine, your immune system recognizes the pneumococcal polysaccharides as foreign substances and produces antibodies against them. This prepares your body to fight off pneumococcal infections more effectively if you’re exposed to the bacteria in the future.

The conjugation to a carrier protein (such as CRM197, a non-toxic variant of diphtheria toxin) enhances the immune response by engaging T-cells, which leads to a more robust and longer-lasting protection, particularly in infants and young children.[2]

Who should get this vaccine?

The pneumococcal polysaccharide serotype 1 vaccine is typically included in broader pneumococcal conjugate vaccines (PCVs) recommended for:

  • Infants and young children as part of their routine immunization 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
    • Cochlear implants or cerebrospinal fluid leaks

Specific recommendations may vary depending on your country and individual health status. Always consult with your healthcare provider to determine if and when you should receive pneumococcal vaccination.[3]

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing serotype 1 are highly effective in preventing 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.

For example, clinical trials of newer pneumococcal conjugate vaccines that include serotype 1 have demonstrated:

  • High antibody responses against serotype 1 in both children and adults
  • Significant reduction in invasive pneumococcal disease caused by serotype 1
  • Improved effectiveness compared to older polysaccharide vaccines, especially in young children

It’s important to note that while the vaccine is effective against serotype 1, it does not protect against all pneumococcal strains. However, the serotypes included in modern pneumococcal conjugate vaccines cover the most common and severe disease-causing strains.[4]

Is it safe?

Pneumococcal conjugate vaccines containing serotype 1 have been extensively studied and have demonstrated a good safety profile. They have been approved by regulatory agencies worldwide and are included in many national immunization programs.

Clinical trials and post-marketing surveillance have shown that these vaccines are generally well-tolerated in both children and adults. As with any vaccine, there is a small risk of side effects, but serious adverse reactions are rare.[5]

What are the potential side effects?

Most side effects of pneumococcal vaccines are mild and short-lived. Common side effects may include:

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

Serious allergic reactions are very rare but can occur. If you experience symptoms such as difficulty breathing, rapid heartbeat, or severe dizziness after vaccination, seek immediate medical attention.[6]

How is it administered?

The pneumococcal polysaccharide serotype 1 vaccine is typically administered as part of a pneumococcal conjugate vaccine. It is given as an intramuscular injection, usually in the upper arm for adults and older children, or in the thigh for infants.

The number of doses and schedule can vary depending on factors such as age and health status:

  • Infants usually receive a series of doses starting at 2 months of age
  • Adults 65 and older typically receive a single dose
  • People with certain health conditions may require additional doses

Your healthcare provider will determine the appropriate vaccination schedule based on your individual circumstances and the specific vaccine being used.[7]

Aspect Details
Vaccine Types Various pneumococcal vaccines including serotype 1 polysaccharide (e.g., V116, PCV20, PPSV23)
Study Populations Adults, children, toddlers, individuals at increased risk for pneumococcal disease
Primary Outcomes Safety (adverse events), Immunogenicity (OPA titers, IgG levels)
Secondary Outcomes Comparison of immune responses, cross-reactive responses, geometric mean fold rises
Study Designs Randomized, controlled, open-label or double-blind trials
Key Measurements Antibody levels, percentage of participants with ≥4-fold rise in antibodies, local and systemic reactions
Follow-up Periods Typically 30 days to several months post-vaccination
Special Considerations Evaluation in high-risk groups, comparison with existing vaccines, assessment of different dosing schedules

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety and immune response (immunogenicity) of various pneumococcal vaccines containing serotype 1 polysaccharide in different populations, including adults, children, and those at higher risk for pneumococcal disease.
  • What are some of the key outcomes being measured in these trials? Key outcomes include the levels of antibodies produced against pneumococcal serotypes (measured by OPA and IgG), the percentage of participants experiencing adverse events, and the comparison of immune responses between different vaccine formulations or schedules.
  • Who are the typical participants in these trials? Participants vary by study but include healthy adults, children, toddlers, and individuals with increased risk factors for pneumococcal disease such as diabetes, chronic liver disease, chronic lung disease, or chronic kidney disease.
  • What are some common exclusion criteria for these trials? Common exclusion criteria include history of severe allergic reactions to vaccine components, certain immunodeficiency conditions, recent receipt of other vaccines, and history of invasive pneumococcal disease.
  • How long do these clinical trials typically last? The duration varies, but many trials involve follow-up periods of several weeks to months after vaccination to assess immune responses and monitor for any delayed adverse events.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 1

  • 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

  • Pneumococcal polysaccharide: A component of the pneumococcal bacteria's outer coating that is used in vaccines to stimulate an immune response against specific serotypes of the bacteria.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcal bacteria.
  • 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 indicates how well antibodies can help immune cells engulf and destroy bacteria.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of participants in a study.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to elicit a stronger immune response, especially in young children.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response.
  • 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.
  • Geometric mean fold rise (GMFR): A measure of the average increase in antibody levels after vaccination compared to before vaccination.

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
  7. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/