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Pneumococcal Polysaccharide Serotype 3 Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article examines clinical trials investigating the use of pneumococcal polysaccharide serotype 3 conjugate vaccine adsorbed on aluminum phosphate. These trials aim to evaluate the safety, efficacy, and immune responses of this vaccine in various populations, including healthy adults, infants, and those at increased risk of pneumococcal disease. The studies explore different formulations, dosing schedules, and combinations with other vaccines to optimize protection against pneumococcal infections.

Table of Contents

What is this vaccine?

This vaccine is a component of larger pneumococcal vaccines, specifically designed to protect against pneumococcal serotype 3. It is part of vaccines like Apexxnar and Prevenar 13, which are pneumococcal conjugate vaccines. These vaccines contain multiple pneumococcal serotypes to provide broad protection against pneumococcal diseases.[1]

The full name – “Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197 Adsorbed on Aluminium Phosphate” – describes its key components:

  • Pneumococcal Polysaccharide Serotype 3: This is the specific part of the pneumococcus bacteria that the vaccine targets.
  • Conjugated to CRM197: CRM197 is a carrier protein that helps boost the immune response.
  • Adsorbed on Aluminium Phosphate: This is an adjuvant that further enhances the immune response.

How does it work?

This vaccine works by stimulating the body’s immune system to produce antibodies against pneumococcal serotype 3. When the vaccine is injected, the immune system recognizes the pneumococcal polysaccharide as foreign and produces antibodies against it. The CRM197 protein and aluminium phosphate help to enhance this immune response.[1]

If a person later encounters the real pneumococcal serotype 3 bacteria, their immune system is primed to recognize and fight off the infection more effectively.

What diseases does it prevent?

As part of broader pneumococcal vaccines, this component helps prevent diseases caused by Streptococcus pneumoniae serotype 3, including:

  • 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 (particularly in children)

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

How is it administered?

This vaccine is administered as an intramuscular injection, typically in the upper arm for adults or the thigh for infants. It is given as part of a larger pneumococcal vaccine (like Apexxnar or Prevenar 13) that includes multiple serotypes.[1]

The dosing schedule can vary depending on age and risk factors. For example:

  • Infants may receive a series of doses at 2, 4, 6, and 12-15 months of age
  • Adults 65 years and older may receive a single dose
  • People with certain medical conditions may have different schedules

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing this serotype 3 component are effective in preventing invasive pneumococcal disease. However, the effectiveness can vary depending on the specific vaccine, age group, and type of pneumococcal disease.[2]

For example, one study found that the 20-valent pneumococcal conjugate vaccine (which includes serotype 3) was effective against vaccine-type community-acquired pneumonia in adults aged 65 and older.[3]

Is it safe?

Pneumococcal conjugate vaccines containing this component have been shown to have a good safety profile. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fever
  • Fatigue
  • Decreased appetite
  • Irritability (in children)

Serious side effects are rare. As with any vaccine, there is a very small risk of severe allergic reaction.[2]

Who should get this vaccine?

This vaccine, as part of larger pneumococcal vaccines, is generally recommended for:

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

However, specific recommendations can vary by country and individual circumstances. It’s important to consult with a healthcare provider to determine if and when you should receive a pneumococcal vaccine.[2]

Ongoing research

Research on pneumococcal vaccines is ongoing to improve their effectiveness and expand their coverage. Some current areas of study include:

  • Evaluating the long-term effectiveness of newer pneumococcal vaccines in different populations[3]
  • Studying the immune response to pneumococcal vaccines in various age groups[4]
  • Investigating the potential of combining pneumococcal vaccines with other vaccines, such as those for respiratory syncytial virus (RSV)[5]

These ongoing studies aim to further improve our ability to prevent pneumococcal diseases and protect vulnerable populations.

Trial Aspect Details
Populations Studied Healthy adults, infants, toddlers, adults ≥65 years, individuals at increased risk of pneumococcal disease
Key Objectives Evaluate safety, immunogenicity, efficacy, and effectiveness of pneumococcal vaccines
Primary Endpoints Immune responses (antibody levels), adverse events, vaccine effectiveness against pneumococcal disease
Secondary Endpoints Comparison to other pneumococcal vaccines, long-term protection, specific serotype responses
Administration Intramuscular injection, various dosing schedules
Combination Studies Co-administration with RSV vaccines, comparison of different pneumococcal serotype combinations
Special Considerations Evaluation in high-risk groups, assessment of long-term safety and efficacy

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, efficacy, and immune responses of pneumococcal polysaccharide serotype 3 conjugate vaccine in different populations and formulations.
  • Who are the typical participants in these trials? Participants include healthy adults, infants, toddlers, and individuals at increased risk of pneumococcal disease, depending on the specific trial.
  • What are some of the key outcomes being measured? Key outcomes include immune responses (antibody levels), safety profiles (adverse events), vaccine effectiveness against pneumococcal disease, and comparisons to other pneumococcal vaccines.
  • How is the vaccine typically administered in these trials? The vaccine is usually administered as an intramuscular injection, with dosing schedules varying by trial and population.
  • Are there any combination vaccines being studied? Yes, some trials are examining combinations of pneumococcal serotypes or co-administration with other vaccines like those for respiratory syncytial virus (RSV).

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 3 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 used in vaccines to stimulate immunity against pneumococcal infections.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response.
  • Adsorbed: The process of attaching vaccine components to an adjuvant like aluminum phosphate to improve the immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates the ability to promote ingestion and killing of bacteria by immune cells.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Geometric mean titer (GMT): A measure of the average antibody level in a group of subjects, calculated using the geometric mean.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Vaccine effectiveness: A measure of how well a vaccine prevents disease in real-world conditions outside of clinical trials.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by common bacteria like Streptococcus pneumoniae.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2022-502791-22-01
  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-id/2023-505154-18-00
  5. http://clinicaltrials.eu/trial-id/2022-501988-40-00