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Pneumococcal Polysaccharide Serotype 20

This article summarizes several clinical trials investigating the safety and efficacy of vaccines containing pneumococcal polysaccharide serotype 20, particularly the V116 vaccine. These studies aim to evaluate the immune response, tolerability, and protective effects in various populations, including adults at increased risk of pneumococcal disease and children/adolescents. The trials compare V116 to existing pneumococcal vaccines and assess its potential as a new preventive option against pneumococcal infections.

Table of Contents

What is PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20?

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 is a component of pneumococcal vaccines, specifically designed to protect against a particular strain (serotype 20) of the bacterium Streptococcus pneumoniae[1]. This bacterium, also known as pneumococcus, can cause various infections, including pneumonia, meningitis, and bloodstream infections.

What is it used for?

This vaccine component is used to prevent pneumococcal infections caused by the serotype 20 strain of Streptococcus pneumoniae. It is typically included in broader pneumococcal vaccines that protect against multiple serotypes[1]. These vaccines are particularly important for:

  • Adults aged 60-85 years
  • People with increased risk for pneumococcal disease
  • Individuals with certain medical conditions that may make them more susceptible to pneumococcal infections

How does it work?

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 works by stimulating the body’s immune system to produce antibodies against the specific polysaccharide coating of the serotype 20 pneumococcal bacteria. When exposed to the actual bacteria in the future, these antibodies help the body recognize and fight off the infection more effectively[1].

How is it administered?

The vaccine containing PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 is typically administered as an intramuscular injection. It is usually given as a single 0.5 ml dose[1]. The specific administration details may vary depending on the particular vaccine formulation and the patient’s age and health status.

How effective is it?

The effectiveness of vaccines containing PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20 is being studied in ongoing clinical trials. These studies aim to evaluate the immune response generated by the vaccine, measured by increases in antibody levels and T cell responses[2]. The effectiveness can be assessed by looking at:

  • Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs)
  • Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
  • The proportion of participants achieving a significant rise in antibody levels

Safety and Side Effects

As with any vaccine, there may be potential side effects associated with vaccines containing PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20. Common side effects may include:

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

Serious side effects are rare but can occur. It’s important to discuss potential risks and benefits with your healthcare provider[1].

Ongoing Research

Several clinical trials are currently underway to further study vaccines containing PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20. These studies aim to:

  • Evaluate the safety and immunogenicity in various populations, including adults aged 60-85 years and those at increased risk for pneumococcal disease[2]
  • Compare the effectiveness of new vaccine formulations to existing ones
  • Assess long-term protection and the potential need for booster doses
  • Investigate the optimal timing of vaccine administration for maximum effectiveness[3]

These ongoing studies will provide valuable information to further improve the prevention of pneumococcal infections and optimize vaccination strategies.

Study Aspect Details
Vaccine V116 (21-valent pneumococcal conjugate vaccine)
Main Populations Adults 18-64 years at increased risk, Adults 50+ years, Children/adolescents at increased risk
Comparators PCV15, PPSV23
Primary Outcomes Safety (adverse events), Immunogenicity (OPA GMTs, antibody responses)
Secondary Outcomes Serotype-specific responses, Geometric mean fold rises, Proportion with ≥4-fold titer increases
Study Designs Randomized, double-blind, active comparator-controlled
Follow-up Duration Typically 6-12 months
Key Exclusions Prior pneumococcal vaccination, immunodeficiency, recent use of immunosuppressive drugs

FAQ

  • What is the main purpose of the V116 vaccine clinical trials? The main purpose is to evaluate the safety, tolerability, and immunogenicity of V116, a new pneumococcal conjugate vaccine, in different populations including adults at increased risk of pneumococcal disease and children/adolescents.
  • How is V116 being compared to other pneumococcal vaccines in these trials? V116 is being compared to vaccines like PCV15 (15-valent pneumococcal conjugate vaccine) and PPSV23 (23-valent pneumococcal polysaccharide vaccine) in terms of immune responses, safety profiles, and efficacy in preventing pneumococcal infections.
  • What are some of the key outcomes being measured in these studies? Key outcomes include serotype-specific antibody responses, opsonophagocytic activity (OPA) levels, adverse events, and in some cases, the incidence of invasive pneumococcal disease or pneumonia.
  • Who are the main participant groups in these V116 clinical trials? The main participant groups include adults aged 18-64 years at increased risk of pneumococcal disease, adults 50 years and older, and children/adolescents with increased risk for pneumococcal disease.
  • How long do these clinical trials typically last? The duration varies, but many of the trials have follow-up periods ranging from 6 months to 1 year after vaccination to assess both short-term and longer-term outcomes.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 20

  • 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 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 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

  • Study on Long-term Safety and Efficacy of Pegcetacoplan for Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +2

Glossary

  • Pneumococcal polysaccharide serotype 20: A specific type of pneumococcal bacteria capsule component used in vaccines to stimulate immunity against that particular strain of Streptococcus pneumoniae.
  • V116: An investigational 21-valent pneumococcal conjugate vaccine being studied for its potential to prevent pneumococcal disease in various populations.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies can help immune cells engulf and destroy bacteria.
  • Serotype-specific: Referring to immune responses or vaccine components that are targeted to particular strains or types of pneumococcal bacteria.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • PCV15: A 15-valent pneumococcal conjugate vaccine used as a comparator in some of the clinical trials.
  • PPSV23: A 23-valent pneumococcal polysaccharide vaccine used as a comparator in some of the clinical trials.
  • Geometric mean titers (GMTs): A way of measuring average antibody levels in a group of people, often used to assess vaccine responses.
  • Adverse events: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Invasive pneumococcal disease: A severe infection caused by Streptococcus pneumoniae bacteria in normally sterile sites like blood or cerebrospinal fluid.

References

  1. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  2. http://clinicaltrials.eu/trial-id/2022-503144-40-00
  3. http://clinicaltrials.eu/trial-id/2024-513558-30-00