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Pneumococcal Polysaccharide Serotype 7F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing pneumococcal polysaccharide serotype 7F conjugated to CRM197 and adsorbed on aluminium phosphate. The vaccine is being studied for prevention of pneumococcal disease in various populations, including healthy adults, infants, and those at increased risk. The trials examine the vaccine’s safety, immunogenicity, and effectiveness when given alone or in combination with other vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 7F conjugate vaccine?

The pneumococcal polysaccharide serotype 7F conjugate vaccine is a component of several pneumococcal conjugate vaccines, including the 13-valent (PCV13) and 20-valent (PCV20) vaccines. It contains the capsular polysaccharide from the 7F serotype of Streptococcus pneumoniae bacteria, which is chemically linked (conjugated) to a carrier protein called CRM197 and adsorbed onto an aluminum phosphate adjuvant.[1]

This vaccine is also known by the following names:

  • Pneumococcal polysaccharide serotype 7F conjugated to CRM197 adsorbed on aluminium phosphate
  • Pneumococcal polysaccharide serotype 7F conjugated to CRM197 carrier protein adsorbed on aluminium phosphate

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the capsular polysaccharide of the 7F serotype of S. pneumoniae. The conjugation to the CRM197 protein helps to enhance the immune response, particularly in young children. The aluminum phosphate adjuvant further boosts the immune response.[1]

When vaccinated individuals are later exposed to the 7F serotype of S. pneumoniae, their immune system recognizes the bacteria and can mount a rapid and effective response to prevent infection.

What is it used for?

This vaccine component helps protect against invasive pneumococcal disease and pneumonia caused by the 7F serotype of S. pneumoniae. It is included in broader pneumococcal conjugate vaccines that protect against multiple serotypes.[1]

Pneumococcal disease can cause serious infections including:

  • Pneumonia (lung infection)
  • Bacteremia (blood infection)
  • Meningitis (infection of the coverings of the brain and spinal cord)
  • Otitis media (middle ear infection)

How is it administered?

The pneumococcal conjugate vaccines containing this component are given as an intramuscular injection, typically in the thigh for infants or the upper arm for older children and adults. The dosing schedule depends on the specific vaccine and the age at which vaccination is started.[1]

How effective is it?

Clinical trials have shown that pneumococcal conjugate vaccines containing the 7F serotype are highly effective at preventing invasive pneumococcal disease caused by this strain. The effectiveness can vary depending on factors like age and immune status of the recipient.[2]

What are the potential side effects?

Common side effects of pneumococcal conjugate vaccines may include:

  • Pain, redness, or swelling at the injection site
  • Fever
  • Irritability
  • Decreased appetite
  • Increased or decreased sleep

Serious allergic reactions are rare but possible. Patients should seek immediate medical attention if they experience symptoms of a severe allergic reaction after vaccination.[2]

Who should get this vaccine?

Pneumococcal conjugate vaccines containing the 7F serotype are recommended for:

  • Infants and young children as part of their routine vaccination schedule
  • Adults 65 years and older
  • Individuals with certain medical conditions that increase their risk of pneumococcal disease

The specific recommendations may vary by country and individual risk factors. Patients should consult with their healthcare provider to determine if and when they should receive a pneumococcal vaccine.[3]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to assess their long-term effectiveness, impact on pneumococcal disease rates, and potential for preventing conditions like community-acquired pneumonia in adults. Some current clinical trials are evaluating:

  • The effectiveness of 20-valent pneumococcal conjugate vaccine (which includes the 7F serotype) against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older[4]
  • Co-administration of pneumococcal conjugate vaccines with other vaccines like those for respiratory syncytial virus (RSV)[2]
  • Use of pneumococcal conjugate vaccines in specific populations like adults with increased risk for pneumococcal disease[5]

These ongoing studies will help to further refine vaccination strategies and potentially expand the use of pneumococcal conjugate vaccines to protect more people from pneumococcal infections.

Trial Number Population Intervention Primary Endpoints Key Findings
2022-501519-15-00 Healthy adults 20-40 years old Pneumococcal vaccination and lymph node fine needle aspiration Percentage of germinal center B cells in lymph node aspirates Study ongoing, results not yet available
2022-501988-40-00 Adults aged 60 years and older Co-administration of pneumococcal (PCV20) and RSV vaccines 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
2023-507293-40-00 Adults aged 65 years and older 20-valent pneumococcal conjugate vaccine (PCV20) Vaccine effectiveness against vaccine-type pneumonia 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

FAQ

  • What populations are being studied in these clinical trials? The clinical trials are studying various populations, including healthy adults, infants, elderly adults aged 65 and older, and adults aged 18-64 at increased risk of pneumococcal disease.
  • 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 compare it to other pneumococcal vaccines or examine its use in combination with other vaccines.
  • How is the vaccine administered in these trials? The vaccine is typically administered as an intramuscular injection. Some trials involve a single dose, while others examine multiple doses or booster shots.
  • What are some of the key endpoints being measured? Key endpoints include immune responses (measured by antibody levels), rates of pneumococcal disease, safety outcomes like adverse events, and in some cases, effectiveness against pneumonia or other clinical outcomes.
  • Are there any notable exclusion criteria for these trials? Common exclusion criteria include previous pneumococcal vaccination, certain medical conditions, immunosuppression, and recent use of certain medications. Specific criteria vary by trial but often aim to exclude those who may be at higher risk of adverse events or who may not mount an adequate immune response.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 7F 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 an immune response against the bacteria.
  • 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.
  • Aluminium phosphate: An adjuvant added to vaccines to boost the immune response to the vaccine components.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of Streptococcus pneumoniae.
  • 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 type of average used to represent antibody levels in a group of subjects, calculated using the geometric mean.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions, often expressed as a percentage.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by Streptococcus pneumoniae among other pathogens.

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-id/2022-502791-22-01
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/
  5. http://clinicaltrials.eu/trial/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/