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Pneumococcal Polysaccharide Serotype 14 Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing polysaccharide serotype 14 conjugated to CRM197 and adsorbed on aluminium phosphate. The vaccine is being studied in various populations including healthy adults, infants, and those at increased risk of pneumococcal disease. The trials aim to evaluate the safety, immunogenicity, and effectiveness of this vaccine formulation against pneumococcal infections.

Table of Contents

What is this vaccine component?

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE is a key ingredient in certain pneumococcal vaccines. It’s a complex name, so let’s break it down:

  • Pneumococcal polysaccharide: This refers to sugar molecules from the outer coating of pneumococcus bacteria.
  • Serotype 14: This indicates it’s from a specific strain of pneumococcus bacteria known as serotype 14.
  • Conjugated to CRM197: The bacterial sugars are chemically attached (conjugated) to a harmless protein called CRM197. This helps make the vaccine more effective, especially in young children.
  • Adsorbed on aluminium phosphate: The vaccine components are attached to a tiny amount of aluminum compound, which acts as an adjuvant to boost the immune response.

This component is just one of several similar ingredients in pneumococcal conjugate vaccines, each targeting a different strain of the bacteria.[1]

How does it work?

When this vaccine component is injected into the body, it stimulates the immune system to produce antibodies against pneumococcal serotype 14. These antibodies can then recognize and help fight off real pneumococcus bacteria if you’re exposed in the future. The conjugation to CRM197 and the aluminum adjuvant help make this immune response stronger and longer-lasting.[1]

What diseases does it help prevent?

This vaccine component, along with others in pneumococcal vaccines, helps prevent diseases caused by Streptococcus pneumoniae bacteria, including:

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

Pneumococcal diseases can be very serious, especially in young children, older adults, and people with weakened immune systems.[1]

What vaccines contain this component?

This specific component is found in several pneumococcal conjugate vaccines, including:

  • Prevenar 13 (also known as Prevnar 13): A 13-valent pneumococcal conjugate vaccine
  • Apexxnar: A newer 20-valent pneumococcal conjugate vaccine

These vaccines contain multiple pneumococcal serotypes, each conjugated to CRM197, to provide broad protection against the most common disease-causing strains.[1][2]

How is it administered?

Vaccines containing this component are typically given as an intramuscular injection, usually in the upper arm for adults or the thigh for infants. The number of doses and schedule can vary depending on age and risk factors:

  • Infants usually receive a series of doses starting at 2 months of age
  • Adults 65 and older typically receive a single dose
  • Some high-risk adults under 65 may also be recommended to receive the vaccine

Always follow your healthcare provider’s recommendations for vaccination.[2]

Safety and side effects

Pneumococcal conjugate vaccines containing this component have been extensively studied and are generally considered very safe. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability (in children)
  • Fatigue
  • Headache
  • Muscle pain

Serious allergic reactions are very rare. As with any medical treatment, discuss any concerns or your medical history with your healthcare provider before vaccination.[2]

Ongoing research

Researchers continue to study pneumococcal vaccines to improve their effectiveness and broaden protection. Some areas of ongoing research include:

  • Developing vaccines that cover even more pneumococcal serotypes
  • Studying the long-term effectiveness of these vaccines in different populations
  • Investigating the impact of widespread vaccination on pneumococcal disease rates
  • Exploring potential uses in specific high-risk groups

For example, one study is looking at the effectiveness of a 20-valent pneumococcal conjugate vaccine (which includes this serotype 14 component) in preventing community-acquired pneumonia in adults 65 and older.[3]

Pneumococcal vaccines have already had a significant impact on reducing the burden of these diseases, and ongoing research aims to build on this success to provide even better protection in the future.

Trial ID Population Intervention Primary Endpoints Key Findings
2022-501519-15-00 Healthy adults 20-40 years old Pneumococcal vaccination and lymph node fine needle aspiration Timing of peak germinal center B cell frequency in lymph node aspirates Study ongoing, results not yet available
2022-501988-40-00 Adults aged 60 years and older Co-administration of 20-valent pneumococcal conjugate vaccine (PCV20) with RSV vaccine Non-inferiority of immune responses when vaccines co-administered vs. given alone Study ongoing, results not yet available
2022-502791-22-01 Adults 18-64 years at increased risk for pneumococcal disease V116 pneumococcal conjugate vaccine Safety and opsonophagocytic antibody responses Study ongoing, results not yet available
2023-506449-40-00 Healthy infants 55-89 days old Meningococcal ABCWY vaccine formulations Safety and immune responses against meningococcal serogroups Study ongoing, results not yet available
2023-507293-40-00 Adults aged 65 and older 20-valent pneumococcal conjugate vaccine (PCV20) Vaccine effectiveness against vaccine-type community-acquired pneumonia Study ongoing, results not yet available

FAQ

  • What populations are being studied in these clinical trials? The clinical trials are studying various populations including healthy adults, infants, adults aged 60 and older, and adults aged 18-64 at increased risk of pneumococcal infection.
  • What are the main objectives of these trials? The main objectives include evaluating the safety, tolerability, immunogenicity, and effectiveness of the pneumococcal vaccine. Some trials also aim to determine optimal timing of vaccination or compare it to other pneumococcal vaccines.
  • How is the vaccine administered in these trials? The vaccine is generally administered as an intramuscular injection. Some trials involve a single dose while others look at multiple doses or co-administration with other vaccines.
  • What are some of the key endpoints being measured? Key endpoints include measures of immune response like antibody levels, rates of adverse events, incidence of pneumococcal disease, and in some cases, quality of life measures or healthcare utilization.
  • Are there any notable exclusion criteria for participants? Common exclusion criteria include history of severe allergic reactions to vaccine components, certain immunocompromising conditions, recent receipt of other vaccines or blood products, and pregnancy/breastfeeding in some trials.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 14 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 component of the bacterial cell wall of Streptococcus pneumoniae that is used in vaccines to stimulate immunity against pneumococcal infections.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response, especially in young children.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on the cell surface.
  • Aluminium phosphate: An adjuvant added to vaccines to enhance the body's immune response to the vaccine.
  • 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 assesses the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells.
  • Geometric mean titer (GMT): A measure of average antibody levels in a group, calculated using the geometric mean to reduce the impact of extreme values.
  • Adverse event (AE): 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, typically in the community.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions, outside of controlled 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/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/