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Pneumococcal Polysaccharide Serotype 19F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of pneumococcal polysaccharide serotype 19F conjugated to CRM197 adsorbed on aluminium phosphate as part of pneumococcal conjugate vaccines. These trials examine the safety, efficacy, and immune responses to pneumococcal vaccines containing this component in various populations, including healthy adults, infants, and those at increased risk of pneumococcal disease. The studies evaluate different formulations and dosing regimens to optimize protection against pneumococcal infections.

Table of Contents

What is pneumococcal polysaccharide serotype 19F vaccine?

Pneumococcal polysaccharide serotype 19F vaccine is a component of vaccines that help protect against infections caused by the bacteria Streptococcus pneumoniae, also known as pneumococcus.[1] This specific component targets the 19F serotype of pneumococcus.

The full name of this vaccine component is “PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE”. Let’s break down what this means:

  • Pneumococcal polysaccharide: This refers to sugar molecules from the outer coating of the pneumococcus bacteria.
  • Serotype 19F: This is one specific strain of pneumococcus that the vaccine protects against.
  • Conjugated to CRM197: The polysaccharide is attached to a carrier protein called CRM197 to enhance the immune response.
  • Adsorbed on aluminium phosphate: The vaccine components are attached to aluminum phosphate, which acts as an adjuvant to further boost the immune response.

How does it work?

This vaccine works by stimulating your immune system to produce antibodies against the 19F serotype of pneumococcus. Here’s how:

  1. The vaccine contains harmless parts of the pneumococcus bacteria (the polysaccharides).
  2. When injected, your immune system recognizes these as foreign.
  3. Your body produces antibodies specifically designed to fight this type of bacteria.
  4. If you’re later exposed to the real 19F pneumococcus, your immune system is primed to quickly recognize and fight it off before it can cause serious infection.

The conjugation to CRM197 and use of aluminum phosphate help make the vaccine more effective, especially in young children and older adults whose immune systems might not respond as strongly to the polysaccharide alone.[1]

What is it used for?

This vaccine component is used to prevent infections caused by the 19F serotype of pneumococcus. These infections can include:

  • Pneumonia: An infection of the lungs
  • Bacteremia: A blood infection
  • Meningitis: An infection of the lining of the brain and spinal cord
  • Otitis media: Middle ear infections (especially in children)

The 19F serotype is included in several pneumococcal vaccines, including the 13-valent (Prevenar 13) and 20-valent (Apexxnar) pneumococcal conjugate vaccines.[1][2]

How is it administered?

This vaccine component is given as part of a larger pneumococcal vaccine. It is typically administered as an intramuscular injection, usually in the upper arm for adults or the thigh for infants. The specific dosing schedule depends on factors like age and risk factors for pneumococcal disease.[2]

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing the 19F serotype are effective at preventing invasive pneumococcal disease caused by this strain. For example:

  • A study on the effectiveness of the 20-valent pneumococcal conjugate vaccine (which includes serotype 19F) in adults aged 65 and older is currently ongoing. This study aims to evaluate the vaccine’s effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia.[3]
  • Another study is investigating the immune response to pneumococcal vaccines, including the response to serotype 19F, in adults with increased risk for pneumococcal disease.[4]

These ongoing studies will provide more specific data on the effectiveness of the 19F component in different populations.

Safety and side effects

Pneumococcal vaccines containing the 19F serotype are generally considered safe. However, like all vaccines, they can cause side effects. Common side effects may include:

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

Serious side effects are rare but can occur. Always discuss potential risks and benefits with your healthcare provider.[2]

Who should get vaccinated?

Pneumococcal vaccines containing the 19F serotype are recommended for:

  • All children under 2 years old
  • Adults 65 years or older
  • People with certain medical conditions that increase their risk of pneumococcal disease

However, the specific recommendations can vary by country and individual circumstances. Your healthcare provider can advise if this vaccine is appropriate for you or your child.[2]

Trial Aspect Details
Vaccine Formulations 13-valent and 20-valent pneumococcal conjugate vaccines containing serotype 19F
Study Populations Healthy adults, infants, older adults (65+), individuals at increased risk of pneumococcal disease
Primary Objectives Safety, immunogenicity, efficacy against pneumococcal disease
Key Outcome Measures Adverse events, antibody levels, opsonophagocytic activity, prevention of pneumococcal infections
Administration Intramuscular injection, various dosing schedules
Comparators Other pneumococcal vaccines, placebo in some trials
Special Considerations Co-administration with other vaccines, effects in immunocompromised individuals

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, efficacy, and immune responses to pneumococcal conjugate vaccines containing serotype 19F and other pneumococcal serotypes in different populations. The trials aim to determine optimal formulations and dosing to prevent pneumococcal infections.
  • Who are the typical participants in these trials? Participants vary by study but include healthy adults, infants, older adults (65+), and those at increased risk of pneumococcal disease. Some trials focus on specific age groups or risk factors.
  • What are some of the key outcomes measured? Key outcomes include safety (adverse events), immune responses (antibody levels), efficacy in preventing pneumococcal disease, and comparisons to existing vaccines. Some trials also look at long-term protection and effects of different dosing schedules.
  • How is the vaccine typically administered in these trials? The vaccine is usually administered as an intramuscular injection. The number of doses and schedule varies by trial, but often involves 1-3 doses given weeks or months apart.
  • Are there any notable side effects observed? While specific side effects aren't detailed in the trial summaries, pneumococcal vaccines are generally well-tolerated. Common side effects can include injection site reactions, fever, and fatigue. Serious side effects are rare but monitored closely in the trials.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 19F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

  • A study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease

    Recruiting

    2 1 1 1
    Investigated drugs:
    Italy Spain

  • A study of IM-101 in adults with generalized myasthenia gravis or ocular myasthenia gravis

    Recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Italy Poland Spain

  • Study of Pneumococcal Vaccine Response in Patients Without a Spleen: Comparing Vaccination Before and After Spleen Removal Using PCV20 and PCV21

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • 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 Pneumococcal Vaccine Response in Healthy Volunteers Using Pneumococcal Polysaccharide Conjugate Vaccine and Drug Combination

    Recruiting

    2 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of the 20-Valent Pneumococcal Vaccine in Adults with Fever and High Risk for Pneumococcal Infection

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effectiveness of 20-Valent Pneumococcal Conjugate Vaccine for Preventing Pneumonia in Adults Aged 65 and Older

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • 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 of RSV vaccine and pneumococcal vaccine combination for patients aged 60 and older with chronic obstructive pulmonary disease

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study of 20-valent pneumococcal conjugate vaccine (PCV20) booster response in healthy adults aged 78-84 years

    Not recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Pneumococcal polysaccharide: A sugar molecule found on the surface of pneumococcus bacteria that helps stimulate an immune response when used in a vaccine.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a protein carrier in conjugate vaccines to enhance the immune response, especially in young children.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcus bacteria.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a stronger antigen (like a protein carrier) to improve the immune response.
  • Aluminium phosphate: An adjuvant added to vaccines to enhance the body's immune response to the vaccine components.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies can help immune cells engulf and destroy bacteria.
  • Geometric mean titer (GMT): A measure of the average antibody levels in a group of people, calculated using the geometric mean.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by pneumococcus bacteria.

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/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/
  4. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/