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Pneumococcal Polysaccharide Serotype 22F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article explores clinical trials investigating the use of pneumococcal polysaccharide serotype 22F conjugate vaccine, a component of the 20-valent pneumococcal conjugate vaccine (20vPnC). These trials aim to evaluate the vaccine’s immune response, safety, and effectiveness in preventing pneumococcal disease in various populations. The studies focus on aspects such as vaccine-induced immunity, co-administration with other vaccines, and real-world effectiveness against community-acquired pneumonia in older adults.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 22F Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 22F Conjugated to CRM197 Adsorbed on Aluminium Phosphate is a component of a vaccine designed to protect against pneumococcal diseases. It is part of a larger vaccine called Apexxnar, which is a 20-valent pneumococcal conjugate vaccine[1]. This means it protects against 20 different types (serotypes) of pneumococcal bacteria, with serotype 22F being one of them.

How Does It Work?

This vaccine works by stimulating your immune system to produce antibodies against specific parts of the pneumococcal bacteria. The “22F” in the name refers to a specific serotype of pneumococcus. The vaccine contains a small piece of the outer coating (polysaccharide) of this bacteria, which is attached (conjugated) to a harmless protein called CRM197. This combination helps your immune system recognize and remember the bacteria better[2].

The aluminium phosphate in the vaccine acts as an adjuvant. An adjuvant is a substance that helps boost the immune response to the vaccine, making it more effective[2].

What Diseases Does It Treat?

This vaccine component, as part of the Apexxnar vaccine, helps prevent diseases caused by Streptococcus pneumoniae bacteria, including:

  • Pneumonia: An infection of the lungs
  • Bacteremia: An infection of the blood
  • Meningitis: An infection of the lining of the brain and spinal cord

These diseases can be particularly serious in older adults, young children, and people with weakened immune systems[3].

Vaccine Composition

The Apexxnar vaccine, which includes the Pneumococcal Polysaccharide Serotype 22F component, is a suspension for injection that comes in a pre-filled syringe. It contains 20 different pneumococcal serotypes, each conjugated to CRM197 and adsorbed on aluminium phosphate[1].

How is the Vaccine Administered?

The vaccine is typically administered as an intramuscular injection. For adults, it’s usually given as a single 0.5 ml dose[1]. The specific vaccination schedule may vary depending on factors such as age, previous pneumococcal vaccination history, and individual risk factors. Always follow your healthcare provider’s recommendations.

Effectiveness of the Vaccine

Ongoing research is being conducted to evaluate the effectiveness of the 20-valent pneumococcal conjugate vaccine (which includes the serotype 22F component) against pneumonia in adults aged 65 and older. One study aims to determine the vaccine’s effectiveness against radiologically-confirmed community-acquired pneumonia (CAP) caused by vaccine serotypes[3].

The effectiveness is being measured by calculating the vaccine effectiveness (VE) as 1 minus the odds ratio of vaccination among cases versus controls, adjusted for potentially confounding variables[3].

Safety Profile

As with all vaccines, safety is a crucial aspect. The safety profile of the vaccine is being closely monitored in clinical trials. Researchers are tracking various safety indicators, including:

  • The percentage of participants reporting solicited events (expected side effects) within 7 days after vaccination
  • The percentage of participants reporting unsolicited adverse events within 30 days after vaccination
  • The percentage of participants reporting serious adverse events up to 6 months after vaccination[3]

It’s important to note that while side effects can occur, they are generally mild and short-lived. The benefits of vaccination typically outweigh the risks for recommended individuals.

Ongoing Research

Several clinical trials are currently underway to further study this vaccine and its components:

  • A study is examining the immune response to the vaccine in lymph nodes, which could provide insights into how the vaccine stimulates immunity[1].
  • Another study is investigating the co-administration of this pneumococcal vaccine with an RSV (Respiratory Syncytial Virus) vaccine in older adults[2].
  • A large-scale effectiveness study is being conducted to evaluate how well the vaccine prevents pneumonia in adults aged 65 and older in real-world settings[3].

These ongoing studies will provide more information about the vaccine’s effectiveness, safety, and optimal use in different populations.

Aspect Details
Vaccine Composition 20-valent pneumococcal conjugate vaccine (20vPnC) including serotype 22F conjugated to CRM197 and adsorbed on aluminum phosphate
Target Populations Adults aged 60 years and older, adults aged 65 years and older with suspected community-acquired pneumonia
Main Objectives Evaluate immune response, safety, reactogenicity, and effectiveness against pneumococcal disease
Key Endpoints Opsonophagocytic antibody titers, RSV neutralizing antibody titers, adverse events, vaccine effectiveness against community-acquired pneumonia
Study Designs Randomized controlled trials, test-negative design for effectiveness study
Co-administration Evaluation of co-administration with RSV vaccine in some trials
Safety Assessments Monitoring of solicited and unsolicited adverse events, serious adverse events
Effectiveness Measures Vaccine effectiveness against radiologically-confirmed community-acquired pneumonia in real-world settings

FAQ

  • What is the main purpose of the pneumococcal polysaccharide serotype 22F conjugate vaccine? The pneumococcal polysaccharide serotype 22F conjugate vaccine is a component of the 20-valent pneumococcal conjugate vaccine (20vPnC). Its main purpose is to prevent pneumococcal diseases caused by the 22F serotype of Streptococcus pneumoniae bacteria in various populations, particularly in older adults.
  • How is the vaccine's effectiveness being studied in clinical trials? The vaccine's effectiveness is being studied through various methods, including measuring antibody responses, evaluating its ability to prevent community-acquired pneumonia, and assessing its performance when co-administered with other vaccines. One study is using a test-negative design to evaluate the effectiveness of 20vPnC against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older.
  • What are some of the key endpoints being measured in these clinical trials? Key endpoints include opsonophagocytic antibody titers for pneumococcal vaccine serotypes, RSV-A and RSV-B neutralizing antibody titers, percentage of participants reporting adverse events, and vaccine effectiveness against community-acquired pneumonia caused by vaccine serotypes.
  • Are there any specific populations being targeted in these clinical trials? Yes, the clinical trials are targeting various populations. One study focuses on healthy volunteers aged 60 years and older, while another specifically targets adults aged 65 years and older who are hospitalized with suspected community-acquired pneumonia.
  • What is the significance of studying the co-administration of the pneumococcal vaccine with other vaccines? Studying co-administration is important to understand if the pneumococcal vaccine can be safely and effectively given at the same time as other vaccines, such as the RSV vaccine. This information can help optimize vaccination schedules and improve overall vaccine coverage in target populations.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 22F 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

  • 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

  • Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland Spain

Glossary

  • Pneumococcal polysaccharide serotype 22F: A specific type of pneumococcal bacteria (Streptococcus pneumoniae) that is targeted by the 20-valent pneumococcal conjugate vaccine. The '22F' refers to the specific serotype of the bacteria.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response to polysaccharide antigens.
  • Opsonophagocytic antibody titers: A measure of the functional antibodies that can facilitate the uptake and killing of bacteria by immune cells, used to assess the effectiveness of pneumococcal vaccines.
  • Community-acquired pneumonia (CAP): A type of pneumonia that is acquired outside of healthcare settings, often caused by various pathogens including Streptococcus pneumoniae.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome (e.g., infection or disease) in real-world conditions, often expressed as a percentage.
  • Test-negative design: A study design used to evaluate vaccine effectiveness by comparing vaccination status among individuals who test positive for a disease to those who test negative.
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through radiological imaging techniques, such as chest X-rays or CT scans.
  • Serotype: A distinct variation within a species of bacteria, characterized by specific surface structures that can be identified by antibodies.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a stronger antigen to improve the immune response, especially in young children and older adults.
  • RSV (Respiratory Syncytial Virus): A common respiratory virus that can cause severe infections, particularly in infants and older adults, often studied alongside pneumococcal vaccines due to similar target populations.

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/