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Pneumococcal Polysaccharide Serotype 9N

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 9N as part of pneumococcal vaccines. These trials aim to evaluate the safety, efficacy, and immune responses to vaccines containing this serotype in various populations, including adults at increased risk of pneumococcal disease. The studies examine different formulations and combinations of pneumococcal vaccines to optimize protection against pneumococcal infections.

Table of Contents

What is the pneumococcal polysaccharide serotype 9N vaccine?

The pneumococcal polysaccharide serotype 9N vaccine is a component of broader pneumococcal vaccines that help protect against infections caused by the Streptococcus pneumoniae bacteria, also known as pneumococcus.[1] This particular serotype, 9N, is one of many pneumococcal strains that can cause serious illnesses.

Pneumococcal vaccines containing the 9N serotype are typically part of multi-valent vaccines, meaning they protect against multiple pneumococcal strains. For example, it may be included in vaccines like Pneumovax 23, which protects against 23 different pneumococcal serotypes.[2]

How does it work?

The vaccine works by introducing a small amount of polysaccharide (a type of sugar molecule) from the outer coating of the pneumococcus bacteria into your body. This polysaccharide is specific to the 9N serotype. When your immune system encounters this polysaccharide, it produces antibodies against it. These antibodies then provide protection if you’re later exposed to the actual 9N pneumococcal bacteria.[1]

This process, known as active immunization, helps your body build immunity against pneumococcal infections caused by the 9N serotype.

Who needs this vaccine?

Pneumococcal vaccines containing the 9N serotype are typically recommended for:

  • Adults aged 65 years and older
  • People with certain chronic health conditions that increase their risk of pneumococcal disease
  • Individuals with weakened immune systems
  • Smokers

Some specific groups that may benefit from this vaccine include:[3]

  • People with diabetes mellitus
  • Those with chronic liver disease
  • Individuals with chronic obstructive pulmonary disease (COPD)
  • People with chronic heart disease
  • Those with chronic kidney disease

How is it administered?

The pneumococcal polysaccharide serotype 9N vaccine is typically administered as part of a broader pneumococcal vaccine. It is given as an injection, usually into the muscle of the upper arm or thigh. For most adults, a single dose is sufficient.[2]

The vaccine is often given as a 0.5 ml dose in a pre-filled syringe or vial. It’s important to note that the vaccine should be given by a healthcare professional who can monitor for any immediate allergic reactions.

How effective is it?

The effectiveness of pneumococcal vaccines containing the 9N serotype can vary depending on factors like age and overall health. However, studies have shown that these vaccines are generally effective in reducing the risk of invasive pneumococcal disease.

Research indicates that pneumococcal polysaccharide vaccines can stimulate the production of antibodies against the included serotypes, including 9N. This immune response helps protect against serious pneumococcal infections.[1]

Is it safe?

Pneumococcal vaccines containing the 9N serotype have been extensively studied and are considered safe for most people. They have been approved by regulatory agencies like the FDA and EMA after rigorous testing.[2]

However, as with any medical treatment, there are some considerations:

  • People with severe allergies to any vaccine components should not receive the vaccine
  • Those who have had a severe reaction to a previous dose should consult their doctor before getting another dose
  • Pregnant women should consult their healthcare provider before receiving the vaccine

What are the potential side effects?

Most side effects of pneumococcal vaccines are mild and short-lived. Common side effects may include:[3]

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

Serious side effects are rare but can include severe allergic reactions. If you experience symptoms like difficulty breathing, rapid heartbeat, or dizziness after receiving the vaccine, seek medical attention immediately.

Remember, the benefits of protection against pneumococcal disease typically outweigh the risks of vaccine side effects for most people. Always consult with your healthcare provider to determine if this vaccine is right for you based on your individual health status and risk factors.

Trial Aspect Details
Study Populations Adults aged 18-64 at increased risk for pneumococcal disease, adults 50+ years, adults 60-85 years, children and adolescents at higher risk
Vaccine Formulations V116 (21-valent conjugate vaccine), PPSV23 (23-valent polysaccharide vaccine), PCV15 (15-valent conjugate vaccine)
Primary Objectives Safety, tolerability, immunogenicity of vaccines containing serotype 9N
Immune Response Measurements Serotype-specific OPA GMTs, IgG GMCs, proportion of participants with ≥4-fold rise in antibody levels
Safety Assessments Monitoring of adverse events, including injection-site reactions and systemic events
Study Designs Randomized, double-blind, active comparator-controlled trials; some with extension studies
Follow-up Periods Ranging from 30 days post-vaccination to 6 months or longer for certain outcomes

FAQ

  • What is pneumococcal polysaccharide serotype 9N? Pneumococcal polysaccharide serotype 9N is one of the bacterial capsule types found in Streptococcus pneumoniae. It is included as an antigen in some pneumococcal vaccines to stimulate immunity against this particular strain of pneumococcus.
  • What populations are being studied in these clinical trials? The trials are studying various adult populations, including those aged 18-64 years at increased risk for pneumococcal disease, adults 50 years and older, and adults aged 60-85 years. Some trials also include children and adolescents at higher risk for pneumococcal infections.
  • What are the main objectives of these clinical trials? The main objectives include evaluating the safety, tolerability, and immunogenicity of pneumococcal vaccines containing serotype 9N. Trials aim to measure antibody responses, compare different vaccine formulations, and assess the vaccines' ability to protect against pneumococcal infections in various populations.
  • How is the immune response to the vaccines measured? Immune responses are typically measured by assessing serotype-specific antibody levels in the blood using assays like opsonophagocytic activity (OPA) and immunoglobulin G (IgG) concentrations. Some trials also examine T cell responses and other immunological markers.
  • Are there any safety concerns being evaluated in these trials? Yes, all trials include safety assessments as a primary objective. This involves monitoring for adverse events, including injection site reactions, systemic reactions, and any serious adverse events that may occur following vaccination.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 9N

  • 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 serotype 9N: A specific type of bacterial capsule found on some strains of Streptococcus pneumoniae. It is used as an antigen in certain pneumococcal vaccines to induce immunity against this particular strain.
  • Opsonophagocytic activity (OPA): A laboratory test that measures the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells. It is used to assess the functional antibody response to pneumococcal vaccines.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation. Measuring IgG levels specific to vaccine antigens helps determine the strength of the immune response to vaccination.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface. In the context of pneumococcal vaccines, different serotypes refer to distinct strains of Streptococcus pneumoniae.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body. In these trials, immunogenicity refers to how well the vaccines stimulate the production of antibodies against pneumococcal serotypes.
  • Geometric mean titers (GMTs): A statistical measure used to quantify antibody levels in a population. It provides an average antibody concentration that accounts for the typically skewed distribution of titer values.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure. In vaccine trials, AEs are carefully monitored to assess safety.
  • T cell response: The activation and proliferation of T lymphocytes in response to a specific antigen. Some trials measure T cell responses to assess the cellular immune response to pneumococcal vaccines.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen with a strong antigen to enhance the immune response. In pneumococcal vaccines, polysaccharides may be conjugated to carrier proteins to improve efficacy, especially in young children.
  • Invasive pneumococcal disease (IPD): A severe infection caused by Streptococcus pneumoniae bacteria in normally sterile sites of the body, such as the bloodstream or cerebrospinal fluid. Prevention of IPD is a key goal of pneumococcal vaccination.

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/study-on-long-term-safety-and-efficacy-of-pegcetacoplan-for-patients-with-c3-glomerulopathy-or-immune-complex-membranoproliferative-glomerulonephritis/
  3. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/