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Pneumococcal Polysaccharide Serotype 9V Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing serotype 9V polysaccharide conjugated to CRM197 and adsorbed on aluminum phosphate. The vaccine is being studied in various populations including healthy adults, infants, and those at increased risk of pneumococcal disease. The trials aim to evaluate the safety, immunogenicity, and effectiveness of this vaccine formulation against pneumococcal infections.

Table of Contents

What is the pneumococcal polysaccharide serotype 9V conjugate vaccine?

The pneumococcal polysaccharide serotype 9V conjugate vaccine is a component of broader pneumococcal conjugate vaccines like Prevenar 13 and Apexxnar. It contains parts of the outer coating (polysaccharide) of the pneumococcus bacteria serotype 9V, which is chemically linked (conjugated) to a non-toxic variant of diphtheria toxin called CRM197. This conjugate is then adsorbed onto aluminum phosphate to enhance the immune response.[1]

This vaccine is designed to protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 9V serotype. Streptococcus pneumoniae can cause serious illnesses like pneumonia, meningitis, and bloodstream infections (sepsis).[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the 9V serotype of pneumococcus. Here’s a breakdown of its components:

  • Polysaccharide: This is a part of the outer coating of the pneumococcus bacteria. By itself, it doesn’t produce a strong, long-lasting immune response, especially in young children.
  • CRM197: This is a carrier protein that helps the immune system recognize the polysaccharide better. It enhances the immune response, particularly in infants and young children.
  • Aluminum phosphate: This acts as an adjuvant, further boosting the immune response to the vaccine.

When vaccinated, your body recognizes these components as foreign and produces antibodies against them. If you’re later exposed to the actual 9V serotype pneumococcus bacteria, your immune system can quickly recognize and fight off the infection.[1]

Who is this vaccine for?

The pneumococcal polysaccharide serotype 9V conjugate vaccine, as part of broader pneumococcal conjugate vaccines, is recommended for:

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

Specific recommendations may vary by country and individual health status. Always consult with your healthcare provider to determine if this vaccine is appropriate for you or your child.[2]

How is it administered?

The vaccine is typically administered as an intramuscular injection, usually in the thigh for infants or the upper arm for older children and adults. It’s given as part of a series of shots, with the number of doses depending on the age at which vaccination begins and individual risk factors.

For example, in the United States, the CDC recommends the following schedule for pneumococcal conjugate vaccines in children:[3]

  • 2 months of age
  • 4 months of age
  • 6 months of age
  • 12-15 months of age (booster dose)

For adults, a single dose may be sufficient, but some high-risk individuals may need additional doses. Your healthcare provider will determine the appropriate schedule for you.

Effectiveness

Studies have shown that pneumococcal conjugate vaccines, including the serotype 9V component, are highly effective in preventing invasive pneumococcal disease caused by the included serotypes. For instance, research indicates that these vaccines have reduced invasive pneumococcal disease in children by more than 90% for the included serotypes.[2]

The effectiveness can vary depending on factors such as age, overall health, and specific pneumococcal serotypes. It’s important to note that while the vaccine is very effective against the included serotypes, it doesn’t protect against all types of pneumococcal bacteria.

Safety and side effects

Pneumococcal conjugate vaccines, including the serotype 9V component, are generally considered safe. Like all vaccines, they can cause side effects, but serious reactions are rare. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability in infants
  • Fatigue
  • Headache
  • Muscle or joint pain

These side effects are usually mild and resolve on their own within a few days. Severe allergic reactions are very rare but can occur. If you experience symptoms of a severe allergic reaction (such as difficulty breathing, rapid heartbeat, or dizziness) after receiving the vaccine, seek medical attention immediately.[2]

Ongoing research

Research on pneumococcal vaccines is ongoing, with scientists working to improve their effectiveness and broaden protection against more serotypes. For example, clinical trials are being conducted on new formulations that include additional serotypes.[2]

One such study is evaluating the immune response to a 20-valent pneumococcal conjugate vaccine (which includes serotype 9V) in adults aged 65 and older. This research aims to determine the vaccine’s effectiveness against vaccine-type radiologically-confirmed community-acquired pneumonia.[4]

These ongoing studies help ensure that pneumococcal vaccines continue to provide optimal protection against pneumococcal diseases as the bacteria evolve and new serotypes emerge.

Study Characteristic Details
Populations studied Healthy adults, infants, adults ≥60 years, adults 18-64 at increased risk
Main objectives Safety, tolerability, immunogenicity, effectiveness against pneumococcal disease
Vaccine administration Intramuscular injection, single or multiple dose regimens
Key endpoints Antibody responses, disease rates, adverse events, vaccine effectiveness
Special considerations Co-administration with other vaccines, effectiveness in high-risk groups
Study designs Randomized controlled trials, observational studies
Geographic locations Multiple countries involved

FAQ

  • What populations are being studied in these clinical trials? The clinical trials are studying various populations including healthy adults, infants, adults aged 60 and older, and adults aged 18-64 at increased risk of pneumococcal infection.
  • 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 are specifically looking at vaccine efficacy against community-acquired pneumonia in older adults.
  • How is the vaccine administered in these studies? The vaccine is generally administered as an intramuscular injection. Some studies involve a single dose while others are evaluating multiple dose regimens.
  • 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 studies, vaccine effectiveness against pneumonia.
  • Are there any studies looking at co-administration with other vaccines? Yes, one study is evaluating co-administration of the pneumococcal vaccine with an RSV vaccine in older adults to assess safety and immune responses when given together.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 9V 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 vaccine: A vaccine that helps protect against infections caused by Streptococcus pneumoniae bacteria, also known as pneumococcus.
  • 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 protein carrier in conjugate vaccines to enhance the immune response.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, in the general community.
  • 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, calculated by multiplying all values and taking the nth root.
  • 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, outside of clinical trials.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen with a strong antigen to elicit a stronger immune response, especially in young children.

References

  1. http://clinicaltrials.eu/trial-id/2022-501988-40-00
  2. http://clinicaltrials.eu/trial-id/2022-502791-22-01
  3. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/