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Pneumococcal Polysaccharide Serotype 22F

This article summarizes clinical trials investigating pneumococcal vaccines containing the serotype 22F, which is one of the pneumococcal polysaccharides included in newer pneumococcal conjugate vaccines. These trials aim to evaluate the safety, immune responses, and effectiveness of vaccines with serotype 22F in preventing pneumococcal disease in different populations, including healthy adults and those at increased risk. The studies examine various aspects such as antibody responses, vaccine efficacy against pneumonia, and comparisons to existing pneumococcal vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 22F vaccine?

The pneumococcal polysaccharide serotype 22F vaccine is a component of newer pneumococcal vaccines designed to protect against pneumococcal disease. It is specifically targeted against the 22F serotype of Streptococcus pneumoniae bacteria.[1] This serotype is one of the additional strains included in newer 20-valent pneumococcal conjugate vaccines like Apexxnar, which provides broader protection compared to older 13-valent vaccines.[1]

Pneumococcal disease refers to any infection caused by Streptococcus pneumoniae bacteria. These infections can range from mild to severe and include pneumonia, meningitis, and bloodstream infections. Pneumococcal vaccines aim to prevent these potentially serious diseases.

How does it work?

The pneumococcal polysaccharide serotype 22F vaccine works by stimulating the body’s immune system to produce antibodies against the outer coating (polysaccharide) of the 22F strain of pneumococcus bacteria. In the Apexxnar vaccine, this polysaccharide is chemically attached (conjugated) to a carrier protein called CRM197 and adsorbed onto aluminum phosphate.[1]

This conjugation process enhances the immune response, especially in young children. When vaccinated individuals are later exposed to the 22F pneumococcal strain, their immune system recognizes it and can respond quickly to prevent infection.

Who should get this vaccine?

The pneumococcal polysaccharide serotype 22F vaccine, as part of broader pneumococcal vaccines, is generally recommended for:

  • Adults aged 65 years and older[2]
  • Adults aged 18-64 with certain chronic medical conditions or risk factors[3]
  • Children and adolescents with increased risk of pneumococcal disease[4]

Specific risk factors that may warrant vaccination include:

  • Chronic heart, lung, or liver disease
  • Diabetes
  • Chronic kidney disease
  • Weakened immune system
  • Cochlear implants
  • Cerebrospinal fluid leaks

How effective is it?

Studies are ongoing to evaluate the effectiveness of newer pneumococcal vaccines containing the 22F serotype. Early research suggests that including this serotype provides additional protection against pneumococcal disease caused by the 22F strain.

One study found that a 20-valent pneumococcal conjugate vaccine (which includes serotype 22F) was effective in preventing vaccine-type community-acquired pneumonia in adults aged 65 and older.[5] However, more research is needed to determine the specific contribution of the 22F component to overall vaccine effectiveness.

Is it safe?

The pneumococcal polysaccharide serotype 22F vaccine, as part of broader pneumococcal vaccines, has been shown to be generally safe and well-tolerated. Common side effects may include:

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

Serious allergic reactions are rare but possible. As with any vaccine, healthcare providers monitor for any adverse reactions after administration.[3]

How is it given?

The pneumococcal polysaccharide serotype 22F vaccine is typically administered as part of a broader pneumococcal vaccine. It is given as an intramuscular injection, usually in the upper arm (deltoid muscle) for adults or the thigh for young children. The standard dose is 0.5 mL.[1]

For adults, a single dose is usually sufficient. However, some individuals with certain health conditions may require additional doses or boosters. Your healthcare provider can advise on the appropriate vaccination schedule based on your individual circumstances.

Ongoing research

Research is ongoing to further evaluate the safety, effectiveness, and optimal use of pneumococcal vaccines containing the 22F serotype. Current studies are investigating:

  • Long-term effectiveness in preventing pneumococcal disease[5]
  • Immune responses in different age groups and populations[2]
  • Potential for co-administration with other vaccines, such as influenza vaccines[1]
  • Use in children and adolescents at increased risk of pneumococcal disease[4]

These ongoing studies will help refine recommendations for the use of pneumococcal vaccines containing the 22F serotype and potentially expand their use to protect more individuals from pneumococcal disease.

Trial Aspect Details
Populations Studied Healthy adults 65+, adults 18-64 at increased risk, children and adolescents with risk factors
Vaccine Types 20-valent pneumococcal conjugate vaccine (20vPnC), 21-valent pneumococcal conjugate vaccine (V116)
Main Objectives Safety, immunogenicity, effectiveness against pneumococcal disease
Key Endpoints Antibody levels, opsonophagocytic activity, incidence of pneumonia, adverse events
Comparison Vaccines 13-valent pneumococcal conjugate vaccine (13vPnC), 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Study Designs Randomized controlled trials, test-negative design for effectiveness studies
Follow-up Periods Ranging from 30 days post-vaccination to 6 months or longer

FAQ

  • What is pneumococcal polysaccharide serotype 22F? Pneumococcal polysaccharide serotype 22F is one of the bacterial capsule types found in Streptococcus pneumoniae. It is included as one of the serotypes in newer pneumococcal conjugate vaccines to provide broader protection against pneumococcal infections.
  • What populations are being studied in these clinical trials? The clinical trials are studying various populations, including healthy adults aged 65 and older, adults aged 18-64 at increased risk of pneumococcal disease, and children and adolescents with increased risk factors. Some trials also focus on specific groups like those with certain chronic medical conditions.
  • What are the main objectives of these clinical trials? The main objectives include evaluating the safety and tolerability of the vaccines, measuring immune responses through antibody levels, comparing effectiveness to existing pneumococcal vaccines, and assessing the vaccines' ability to prevent pneumococcal pneumonia and other infections.
  • How is the effectiveness of the vaccines being measured? Effectiveness is being measured through various methods, including blood tests to check for antibody levels, monitoring for pneumococcal infections in vaccinated individuals, and comparing infection rates between vaccinated and unvaccinated groups. Some studies are also using specialized tests to detect pneumococcal bacteria in patients with suspected pneumonia.
  • Are there any side effects being monitored in these trials? Yes, the trials are closely monitoring for side effects. They are tracking both local reactions at the injection site (like pain or swelling) and systemic reactions (like fever or fatigue). The studies are also watching for any serious adverse events that might be related to the vaccines.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 22F

  • 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 sugar molecule found on the surface of pneumococcal bacteria. Different serotypes have distinct polysaccharides, which are used in vaccines to stimulate immunity.
  • Serotype: A distinct variation within a species of bacteria, characterized by specific surface structures. In pneumococcal bacteria, serotypes are defined by their unique capsular polysaccharides.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a strong antigen to enhance the immune response. In pneumococcal vaccines, the polysaccharides are often conjugated to a protein carrier.
  • Opsonophagocytic activity (OPA): A measure of antibody function that assesses how well antibodies help immune cells engulf and destroy bacteria.
  • Geometric mean titer (GMT): A way of averaging antibody levels in a group of people, useful for comparing immune responses between different vaccines or groups.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by bacteria like Streptococcus pneumoniae.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions, often expressed as a percentage reduction in disease incidence among vaccinated individuals.
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through chest X-rays or other imaging techniques, providing visual evidence of lung infection.
  • Immunocompromised: Having a weakened immune system, which can be due to various factors including certain medical conditions or treatments.

References

  1. http://clinicaltrials.eu/trial-id/2022-501988-40-00
  2. http://clinicaltrials.eu/trial-id/2023-503144-40-00
  3. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  4. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/
  5. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/