#1 Clinical Trials Search in Europe

Pneumococcal Polysaccharide Serotype 11A

This article summarizes several clinical trials investigating the use of pneumococcal vaccines containing the serotype 11A polysaccharide conjugated to CRM197 protein. These trials aim to evaluate the safety, immunogenicity, and effectiveness of new pneumococcal conjugate vaccines in preventing pneumococcal disease in various populations, including healthy adults, children, and those at increased risk. The studies examine immune responses, vaccine efficacy against pneumonia, and co-administration with other vaccines.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 11A?

Pneumococcal Polysaccharide Serotype 11A is a specific type of sugar coating (polysaccharide) found on the surface of certain pneumococcal bacteria. These bacteria, known as Streptococcus pneumoniae, can cause various infections, including pneumonia, meningitis, and bloodstream infections[1]. The “11A” designation refers to a particular variant of this sugar coating, which is one of many serotypes targeted by modern pneumococcal vaccines.

Role in Pneumococcal Vaccines

Pneumococcal Polysaccharide Serotype 11A is an important component in several pneumococcal vaccines, including the 20-valent pneumococcal conjugate vaccine (20vPnC) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23)[2]. In these vaccines, the serotype 11A polysaccharide is typically conjugated (attached) to a carrier protein called CRM197 and adsorbed onto aluminum phosphate. This formulation helps to enhance the immune response and provide better protection against pneumococcal infections caused by this specific serotype.

Target Population

Pneumococcal vaccines containing serotype 11A are primarily targeted at:

  • Adults aged 65 years and older[3]
  • Adults aged 18-64 years with certain risk factors or chronic conditions[4]
  • Children and adolescents with increased risk of pneumococcal disease[5]

These populations are considered to be at higher risk for pneumococcal infections and can benefit most from the protection offered by the vaccine.

Effectiveness and Immune Response

The effectiveness of pneumococcal vaccines containing serotype 11A is typically measured by the immune response they generate. This is often assessed through:

  • Opsonophagocytic activity (OPA): This measures the ability of antibodies produced by the vaccine to help immune cells engulf and destroy the bacteria[3].
  • Immunoglobulin G (IgG) levels: These are antibodies produced by the immune system in response to the vaccine[3].

Studies have shown that vaccines containing serotype 11A can induce a significant immune response, with many individuals showing a four-fold or greater rise in antibody levels after vaccination[3].

Safety and Side Effects

Pneumococcal vaccines containing serotype 11A have generally been found to be 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
  • Fatigue
  • Headache
  • Muscle or joint pain
  • Fever[4]

These side effects are usually mild and resolve within a few days. Serious allergic reactions are rare but can occur.

Ongoing Research

Research on pneumococcal vaccines, including those containing serotype 11A, is ongoing. Current studies are focusing on:

  • Long-term effectiveness and safety of newer pneumococcal vaccines[6]
  • Optimal vaccination schedules and potential need for booster doses
  • Effectiveness against different types of pneumococcal disease (e.g., pneumonia, invasive pneumococcal disease)
  • Impact on pneumococcal disease rates in different populations

These ongoing studies will help to further refine vaccination strategies and improve protection against pneumococcal infections, including those caused by serotype 11A.

Trial Aspect Details
Vaccine Types 20-valent pneumococcal conjugate vaccine (20vPnC), 21-valent pneumococcal conjugate vaccine (V116), 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Target Populations Adults 65+, adults 18-64 at increased risk, children/adolescents at increased risk
Key Outcomes Immunogenicity (antibody levels), opsonophagocytic activity, safety/adverse events, vaccine effectiveness against pneumonia
Study Designs Randomized controlled trials, test-negative design effectiveness study
Comparators PPSV23, 13-valent pneumococcal conjugate vaccine (PCV13), no vaccination
Co-primary Endpoints Serotype-specific antibody responses, functional antibody activity, rates of vaccine-type pneumonia

FAQ

  • What is the main purpose of these pneumococcal vaccine clinical trials? The main purposes are to evaluate the safety, immune responses (immunogenicity), and effectiveness of new pneumococcal conjugate vaccines containing serotype 11A and other serotypes in preventing pneumococcal disease in different populations.
  • Who are the target populations for these vaccine trials? The trials target various populations including healthy adults aged 65 and older, children and adolescents at increased risk for pneumococcal disease, and adults aged 18-64 with certain medical conditions that increase their risk.
  • What are some of the key outcomes being measured? Key outcomes include immune responses measured by antibody levels and functional antibody activity, rates of pneumonia and other pneumococcal diseases, safety data on adverse events, and vaccine effectiveness when co-administered with other vaccines like influenza vaccine.
  • How do these new vaccines differ from older pneumococcal vaccines? These new vaccines contain more pneumococcal serotypes than older vaccines, including serotype 11A. They use updated conjugate technology to potentially provide broader protection against pneumococcal disease.
  • What are the potential benefits of these new pneumococcal vaccines if proven effective? If proven effective, these vaccines could provide broader protection against pneumococcal disease, potentially reducing rates of pneumonia, invasive disease, and other infections caused by Streptococcus pneumoniae bacteria included in the vaccines.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 11A

  • 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: The sugar coating on the outside of pneumococcal bacteria that helps the immune system recognize and fight the bacteria. Different strains have different polysaccharides.
  • Serotype: A distinct variation within a species of bacteria or virus. For pneumococcus, serotypes are distinguished by differences in their polysaccharide capsule.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like bacterial polysaccharides) to a stronger antigen to create a more powerful immune response.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a protein carrier in conjugate vaccines to enhance the immune response.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of functional antibody activity 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 people that accounts for wide variations in individual responses.
  • Community-acquired pneumonia (CAP): Pneumonia acquired outside of a healthcare setting, often caused by pneumococcal bacteria.
  • Invasive pneumococcal disease (IPD): Severe infections caused by pneumococcal bacteria entering normally sterile sites like the bloodstream or spinal fluid.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions outside of clinical trials.

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-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  5. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/
  6. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/