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Pneumococcal Polysaccharide Serotype 1 Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes several clinical trials investigating the use of pneumococcal conjugate vaccines containing pneumococcal polysaccharide serotype 1 conjugated to CRM197 and adsorbed on aluminium phosphate. These vaccines, including 13-valent and 20-valent formulations, are being studied for their safety, immunogenicity, and effectiveness in preventing pneumococcal disease in various populations, from infants to older adults. The trials cover a range of objectives, from evaluating immune responses to assessing vaccine effectiveness against pneumonia in real-world settings.

Table of Contents

What is the pneumococcal conjugate vaccine?

The pneumococcal conjugate vaccine is designed to protect against infections caused by the bacteria Streptococcus pneumoniae, also known as pneumococcus. This vaccine contains components from multiple serotypes (strains) of pneumococcus bacteria.[1]

The specific vaccine discussed here contains pneumococcal polysaccharide serotype 1 conjugated to CRM197 and adsorbed on aluminium phosphate. This is just one of many serotypes included in pneumococcal conjugate vaccines. Current versions protect against 13 or 20 different serotypes.[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against pneumococcal bacteria. Here’s a breakdown of how it functions:

  • Polysaccharide: This is a sugar molecule from the outer coating of the pneumococcus bacteria. The immune system can recognize this as foreign.
  • CRM197: This is a non-toxic form of diphtheria toxin that acts as a carrier protein. It helps make the vaccine more effective, especially in young children.
  • Conjugation: The polysaccharide is chemically linked (conjugated) to the CRM197 protein. This conjugation process improves the immune response.
  • Aluminium phosphate: This compound acts as an adjuvant, which helps boost the overall immune response to the vaccine.

When you receive the vaccine, your immune system recognizes these components and develops protective antibodies. If you’re later exposed to pneumococcus bacteria, your body can quickly mount a defense.[1]

Who should get vaccinated?

Pneumococcal conjugate vaccines are recommended for:

  • All infants and young children (typically given in a series starting at 2 months of age)
  • Adults 65 years and older
  • People with certain medical conditions that increase their risk of pneumococcal disease

The exact recommendations may vary by country and specific vaccine formulation. Always consult with your healthcare provider to determine if vaccination is appropriate for you or your child.[1]

How effective is it?

Pneumococcal conjugate vaccines have been shown to be highly effective in preventing serious pneumococcal infections. Studies have demonstrated:

  • A significant reduction in invasive pneumococcal disease in vaccinated populations
  • Decreased rates of pneumonia and ear infections in children
  • Protection against antibiotic-resistant strains of pneumococcus

The effectiveness can vary depending on factors like age, overall health, and specific serotypes included in the vaccine. However, these vaccines have had a substantial positive impact on public health since their introduction.[1]

Is it safe?

Pneumococcal conjugate vaccines have a strong safety record. They have been extensively studied and are continually monitored for safety. The benefits of vaccination in preventing serious pneumococcal infections far outweigh the risks for most people.[1]

Possible side effects

As with any vaccine, some people may experience side effects. Most are mild and resolve quickly. Common side effects can include:

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

Serious allergic reactions are rare but possible. If you experience severe symptoms after vaccination, seek medical attention immediately.[1]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to improve their effectiveness and expand their coverage. Some areas of ongoing research include:

  • Developing vaccines that protect against more serotypes
  • Studying the long-term effectiveness of vaccination
  • Investigating the impact on antibiotic resistance
  • Evaluating the use of these vaccines in different populations

For example, one current study is examining the safety and immune response when co-administering a pneumococcal conjugate vaccine with an RSV (respiratory syncytial virus) vaccine in older adults.[2]

Another study is looking at the effectiveness of a 20-valent pneumococcal conjugate vaccine in preventing pneumonia in adults aged 65 and older.[3]

These ongoing studies help ensure that pneumococcal vaccines continue to provide optimal protection against this potentially serious infection.

Study Type Population Vaccine(s) Primary Objectives
Phase II, Randomized Healthy infants (55-89 days old) MenABCWY-2nd Gen, MenABCWY-1st Gen, MenB, MenACWY-TT Safety, reactogenicity, and immunogenicity of meningococcal vaccines
Phase III, Open-label, Randomized Adults aged 60+ years 20-valent pneumococcal conjugate vaccine (PCV20), RSV vaccine Non-inferiority of immune responses when co-administered
Phase III, Test-negative design Adults aged 65+ years 20-valent pneumococcal conjugate vaccine (PCV20) Vaccine effectiveness against community-acquired pneumonia
Phase III, Randomized Adults aged 18-64 at increased risk 20-valent pneumococcal conjugate vaccine (PCV20) Safety, tolerability, and immunogenicity
Open-label, Extension study Adults with relapsing multiple sclerosis 13-valent pneumococcal conjugate vaccine (PCV13) Long-term safety, tolerability, and effectiveness of ofatumumab

FAQ

  • What populations are being studied in these pneumococcal vaccine trials? The trials are studying diverse populations, including healthy infants as young as 2 months old, adults aged 18-64 with increased risk of pneumococcal disease, and older adults aged 65 and above. Some trials also focus on specific groups like those with relapsing multiple sclerosis or multiple myeloma.
  • What are the main objectives of these clinical trials? The main objectives vary but generally include evaluating the safety and tolerability of the vaccines, assessing immune responses through measures like antibody levels, determining vaccine effectiveness against pneumococcal disease, and studying long-term outcomes in different patient groups.
  • How many serotypes are included in the pneumococcal vaccines being studied? The trials involve both 13-valent (PCV13) and 20-valent (PCV20) pneumococcal conjugate vaccines. These vaccines contain 13 and 20 different pneumococcal serotypes respectively, including serotype 1 conjugated to CRM197 and adsorbed on aluminium phosphate.
  • What types of study designs are being used in these trials? The trials use various designs, including randomized controlled studies, open-label extension studies, and real-world effectiveness studies. Some are single-arm studies, while others compare different vaccine formulations or vaccination schedules.
  • Are there any studies looking at co-administration with other vaccines? Yes, one study is examining the co-administration of a 20-valent pneumococcal conjugate vaccine with an RSV (respiratory syncytial virus) vaccine in adults aged 60 years and older to evaluate immune responses and safety when given together.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 1 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 capsular polysaccharides chemically linked to a carrier protein to enhance the immune response.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to improve the immune response, especially in infants and young children.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface. Different pneumococcal serotypes can cause different types of infections.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A laboratory measure of functional antibody activity, indicating how well antibodies can help immune cells engulf and kill bacteria.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people, useful for comparing immune responses between different groups or over time.
  • Adverse event (AE): 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.
  • 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 a specific outcome (e.g., infection, hospitalization) in real-world conditions.
  • Multiple myeloma: A cancer of plasma cells, a type of white blood cell that normally produces antibodies to help fight infections.

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/