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Pneumococcal Polysaccharide Serotype 23F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of pneumococcal polysaccharide serotype 23F conjugate vaccine, which is part of broader pneumococcal conjugate vaccines. These trials aim to evaluate the safety, efficacy, and immune responses of various pneumococcal vaccine formulations in different populations, including healthy adults, infants, and those at increased risk of pneumococcal disease. The studies explore aspects such as vaccine effectiveness, immune responses, and potential side effects across diverse age groups and medical conditions.

Table of Contents

What is pneumococcal polysaccharide serotype 23F conjugate vaccine?

Pneumococcal polysaccharide serotype 23F conjugate vaccine is a component of pneumococcal conjugate vaccines like Prevenar 13 and Apexxnar. It contains parts of the outer coating (polysaccharide) of the pneumococcus bacteria serotype 23F that have been linked (conjugated) to a non-toxic protein called CRM197. This conjugation helps make the vaccine more effective, especially in young children.[1]

The vaccine also contains aluminum phosphate as an adjuvant, which helps boost the immune response. It is given as an injection to help prevent diseases caused by pneumococcus bacteria.

How does it work?

When injected, the vaccine stimulates the body’s immune system to produce antibodies against the pneumococcal serotype 23F polysaccharide. This prepares the immune system to recognize and fight off pneumococcus bacteria if exposed in the future. The conjugation to the CRM197 protein helps create a stronger, longer-lasting immune response.[2]

What diseases does it help prevent?

This vaccine component helps protect against diseases caused by pneumococcus bacteria serotype 23F, including:

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

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

Who should get this vaccine?

This vaccine component is included in pneumococcal conjugate vaccines recommended for:

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

The specific recommendations may vary by country and individual risk factors. Your healthcare provider can advise if this vaccine is recommended for you or your child.[4]

How is it administered?

The pneumococcal conjugate vaccines containing this component are given as an injection, usually into the muscle of the upper arm or thigh. The number of doses needed depends on the age when vaccination is started and individual risk factors:

  • Infants typically receive 4 doses between 2 months and 15 months of age
  • Adults 65 and older usually receive a single dose
  • The dosing schedule may differ for people with certain medical conditions

Your healthcare provider will determine the appropriate vaccination schedule.[5]

How effective is it?

Clinical trials have shown pneumococcal conjugate vaccines containing the serotype 23F component to be highly effective at preventing invasive pneumococcal disease caused by this serotype. The effectiveness can vary depending on factors like age and immune status.

For example, one study found the vaccine to be over 90% effective against invasive pneumococcal disease caused by vaccine serotypes in young children. The effectiveness in preventing pneumonia and ear infections is somewhat lower but still significant.[1]

Is it safe?

Pneumococcal conjugate vaccines containing this component have been extensively studied and shown to have a good safety profile. They have been used worldwide for many years. Serious side effects are rare.

However, like any medical intervention, there are potential risks. Your healthcare provider can help you weigh the benefits and risks based on your individual situation.[2]

What are the potential side effects?

Most side effects of pneumococcal conjugate vaccines are mild and resolve on their own within a few days. Common side effects may include:

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

Serious allergic reactions are very rare but can occur. Seek immediate medical attention if you experience signs of a severe allergic reaction like difficulty breathing, rapid heartbeat, or dizziness after vaccination.[3]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to assess their long-term effectiveness, optimal dosing schedules, and potential for preventing additional types of infections. Some current areas of investigation include:

  • Evaluating the effectiveness of different dosing schedules in various populations
  • Studying the impact of widespread vaccination on pneumococcal disease patterns
  • Developing next-generation vaccines that may provide broader protection

For example, one ongoing clinical trial is assessing the safety and effectiveness of a 20-valent pneumococcal conjugate vaccine (which includes serotype 23F) in adults aged 65 and older.[5]

As research progresses, recommendations for pneumococcal vaccination may be updated to ensure optimal protection against pneumococcal diseases.

Aspect Details
Vaccine Types Various pneumococcal conjugate vaccines including 13-valent, 20-valent, and experimental formulations
Study Populations Healthy adults, infants, older adults (65+), individuals at increased risk of pneumococcal disease
Primary Outcomes Safety, tolerability, immunogenicity, efficacy against pneumococcal disease
Secondary Outcomes Specific immune responses, effectiveness against various pneumococcal serotypes, duration of protection
Safety Monitoring Adverse events, injection site reactions, systemic reactions, serious adverse events
Immune Response Measures Opsonophagocytic activity (OPA), antibody levels, geometric mean titers (GMTs)
Special Considerations Co-administration with other vaccines, effectiveness in specific risk groups, long-term follow-up

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, efficacy, and immune responses of pneumococcal conjugate vaccines containing serotype 23F, along with other serotypes. The trials aim to assess how well these vaccines protect against pneumococcal diseases in various populations.
  • Who are the target populations for these vaccine trials? The target populations vary across trials but include healthy adults, infants, older adults (65 years and above), and individuals at increased risk of pneumococcal disease due to certain medical conditions.
  • What are some of the key outcomes being measured in these trials? Key outcomes include vaccine efficacy against pneumococcal disease, immune responses measured by antibody levels, safety and tolerability of the vaccines, and in some cases, effectiveness against specific outcomes like community-acquired pneumonia.
  • Are there any specific safety concerns being monitored? Yes, the trials monitor for adverse events, including local injection site reactions, systemic reactions, and any serious adverse events. Some studies also specifically track events like infections or hospitalizations.
  • How do these trials compare different pneumococcal vaccine formulations? Some trials compare newer vaccine formulations (like 20-valent vaccines) to existing vaccines (like 13-valent vaccines) or to placebo. They assess factors such as immune responses, safety profiles, and efficacy against pneumococcal disease to determine potential advantages of new formulations.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 23F 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 conjugate vaccine: A vaccine that helps protect against diseases caused by pneumococcal bacteria. It contains bacterial sugars (polysaccharides) linked to a protein to improve the immune response.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface. In the context of pneumococcal vaccines, different serotypes refer to distinct variations of the pneumococcus 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.
  • Opsonophagocytic activity (OPA): A laboratory measure of the functional antibody response to vaccination, indicating how well antibodies can help immune cells engulf and kill bacteria.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Geometric mean titer (GMT): A measure of the average antibody level in a group of subjects, calculated using the geometric mean to reduce the impact of extremely high or low values.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, typically in the general community.
  • Vaccine efficacy: A measure of how well a vaccine prevents disease in vaccinated people compared to unvaccinated people, usually expressed as a percentage.
  • Immunocompromised: Having a weakened immune system, which can be due to certain diseases, medications, or medical treatments.

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-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  4. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  5. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/