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Pneumococcal Polysaccharide Serotype 19F

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 19F conjugate vaccine, which is a component of various pneumococcal vaccines being studied. The trials examine the safety, efficacy, and immune responses to these vaccines in different populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies aim to evaluate new vaccine formulations and compare them to existing pneumococcal vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 19F vaccine?

The pneumococcal polysaccharide serotype 19F vaccine is a component of pneumococcal vaccines that helps protect against infections caused by the 19F strain of Streptococcus pneumoniae bacteria. This bacteria, also known as pneumococcus, can cause serious illnesses like pneumonia, meningitis, and bloodstream infections.[1]

The 19F serotype is one of many pneumococcal strains included in conjugate vaccines like Prevnar 13, Synflorix, and Apexxnar. These vaccines contain purified capsular polysaccharides from different pneumococcal serotypes that are chemically linked (conjugated) to a carrier protein.[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the capsular polysaccharide of the 19F pneumococcal serotype. When conjugated to a carrier protein like CRM197 (a non-toxic variant of diphtheria toxin), it elicits a stronger, longer-lasting immune response, especially in young children.[1]

Specifically, the vaccine triggers the production of opsonophagocytic antibodies. These antibodies coat the bacteria, making them easier for immune cells to recognize and destroy. This helps prevent invasive pneumococcal disease caused by the 19F serotype.[2]

Who needs this vaccine?

The pneumococcal vaccines containing the 19F 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 individual risk factors.[3]

How is it administered?

The pneumococcal conjugate vaccines containing the 19F serotype are typically given as an intramuscular injection. The dosing schedule depends on the specific vaccine and the age at which vaccination begins:

  • For infants, it’s usually given as a series of doses at 2, 4, 6, and 12-15 months of age
  • For adults, it’s often given as a single dose

Your healthcare provider can advise on the appropriate schedule based on your age and risk factors.[3]

Safety and side effects

Pneumococcal conjugate vaccines, including those with the 19F serotype, are generally considered safe and well-tolerated. Common side effects may include:

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

Serious allergic reactions are rare but possible. If you experience symptoms like difficulty breathing, rapid heartbeat, or dizziness after receiving the vaccine, seek medical attention immediately.[4]

Effectiveness

Studies have shown that pneumococcal conjugate vaccines containing the 19F serotype are effective in reducing the incidence of invasive pneumococcal disease caused by this strain. The effectiveness can vary depending on factors like age, immune status, and the specific vaccine formulation.

For example, research has demonstrated that these vaccines can reduce the risk of invasive pneumococcal disease caused by the included serotypes by more than 90% in young children when given as part of the routine vaccination schedule.[4]

Ongoing research

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

  • Developing vaccines that cover additional pneumococcal serotypes
  • Studying the long-term effectiveness and need for booster doses
  • Investigating the impact of widespread vaccination on pneumococcal strain prevalence
  • Evaluating the use of these vaccines in different populations and age groups

For instance, a recent study is looking at the safety and immune response of a new pneumococcal conjugate vaccine candidate in toddlers who previously received a primary series of a 10-valent pneumococcal conjugate vaccine.[5]

As research progresses, our understanding of how to best protect against pneumococcal infections, including those caused by the 19F serotype, continues to improve.

Study Aspect Details
Vaccine Types PCV20, V116, monovalent pneumococcal conjugate candidate, Synflorix, Apexxnar, Prevenar 13, Pneumovax 23
Study Populations Healthy adults, children, adolescents, toddlers, individuals at increased risk of pneumococcal disease
Primary Objectives Safety, tolerability, immunogenicity assessment
Key Measurements OPA titers, IgG levels, adverse events, geometric mean titers/concentrations
Comparison Groups New vaccine formulations vs existing vaccines (e.g. PPSV23, PCV13)
Study Designs Randomized, controlled, open-label, multi-center trials
Follow-up Periods Typically 30 days post-vaccination for immunogenicity, longer for safety monitoring

FAQ

  • What is pneumococcal polysaccharide serotype 19F? Pneumococcal polysaccharide serotype 19F is one of the bacterial capsule types found on Streptococcus pneumoniae. It is included as one of the serotypes in pneumococcal conjugate vaccines to help protect against infections caused by this specific strain of pneumococcus.
  • What populations are being studied in these clinical trials? The trials are studying various populations including healthy adults, children and adolescents, toddlers, and individuals at increased risk of pneumococcal disease due to conditions like diabetes, chronic liver/lung/heart/kidney disease.
  • What are the main goals of these clinical trials? The main goals are to evaluate the safety, tolerability, and immunogenicity of new pneumococcal vaccine formulations. This includes assessing adverse events, measuring antibody responses, and comparing immune responses to existing vaccines.
  • How is the immune response measured in these studies? The immune response is typically measured by looking at opsonophagocytic activity (OPA) titers and immunoglobulin G (IgG) levels specific to the vaccine serotypes. Researchers examine the geometric mean titers/concentrations as well as fold-rises in antibody levels after vaccination.
  • What are some of the new vaccine formulations being tested? Some of the vaccines being evaluated include V116 (a new 21-valent pneumococcal conjugate vaccine), PCV20 (20-valent pneumococcal conjugate vaccine), and investigational monovalent pneumococcal conjugate vaccines. These are being compared to existing vaccines like PPSV23 and PCV13.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 19F

  • 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. For pneumococcus, serotypes are distinguished by differences in their polysaccharide capsule.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a stronger antigen to elicit a more robust immune response, especially in young children.
  • 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.
  • 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 titer (GMT): A way of averaging antibody levels across a group of subjects that reduces the impact of very high or low individual values.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Polysaccharide: A type of carbohydrate consisting of a large number of sugar molecules bonded together. In pneumococcal bacteria, it forms the capsule around the cell.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response.
  • Pneumococcal disease: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, meningitis, and bloodstream infections.

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/2023-505154-18-00