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Pneumococcal Polysaccharide Serotype 6B Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing pneumococcal polysaccharide serotype 6B conjugated to CRM197 and adsorbed on aluminium phosphate. The trials examine the vaccine’s safety, immunogenicity, and effectiveness in various populations, including healthy adults, infants, and those at increased risk of pneumococcal disease. The studies aim to evaluate immune responses, compare different vaccine formulations, and assess the vaccine’s ability to prevent pneumococcal infections.

Table of Contents

What is this vaccine?

This vaccine contains pneumococcal polysaccharide serotype 6B, which is a component that helps protect against infections caused by the bacteria Streptococcus pneumoniae (pneumococcus). Specifically, it targets serotype 6B of this bacteria.[1]

The vaccine is part of a larger group called pneumococcal conjugate vaccines. These vaccines protect against multiple serotypes of pneumococcus bacteria. Some common brand names include Prevnar 13 and Apexxnar, which protect against 13 and 20 serotypes respectively.[2]

How does it work?

The vaccine works by stimulating your immune system to produce antibodies against pneumococcal bacteria. Here’s how:

  • The vaccine contains parts of the bacterial outer coating (polysaccharides) for serotype 6B
  • These polysaccharides are attached (conjugated) to a non-toxic protein called CRM197
  • The combination helps your immune system recognize and respond better to the bacteria
  • Your body produces antibodies that can fight off future infections from this serotype

The vaccine also contains aluminum phosphate as an adjuvant. This helps boost the immune response to make the vaccine more effective.[1]

Who should get vaccinated?

Pneumococcal vaccines are recommended for:

  • All children under 2 years old
  • Adults 65 years and older
  • People with certain medical conditions that increase risk of pneumococcal disease
  • Smokers

Your doctor can advise if you should receive this vaccine based on your age, health status, and vaccination history.[2]

How effective is it?

Studies have shown pneumococcal conjugate vaccines to be highly effective at preventing invasive pneumococcal disease caused by the serotypes included in the vaccine. For adults 65 and older, effectiveness against these serotypes is estimated to be over 75%.[2]

One clinical trial is currently evaluating the effectiveness of a 20-valent pneumococcal conjugate vaccine (which includes serotype 6B) in preventing community-acquired pneumonia in adults 65 and older.[3]

Is it safe?

Pneumococcal conjugate vaccines have been extensively studied and are considered very safe. They have been in use for over 20 years with millions of doses given worldwide.[4]

However, like any medical treatment, there can be risks. Your healthcare provider can discuss if the benefits outweigh any potential risks for your specific situation.

Possible side effects

Most side effects are mild and go away on their own within a few days. Common side effects may include:

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

Serious allergic reactions are rare but possible with any vaccine. Seek immediate medical attention if you experience severe allergic symptoms after vaccination.[2]

How is it given?

The vaccine is given as an injection, usually into the muscle of the upper arm or thigh. For most adults, a single dose is recommended. Some people may need additional doses based on their health status or previous vaccinations.

The typical dose is 0.5 mL. It’s often given at the same time as other vaccines, like the flu shot.[4]

Always follow your healthcare provider’s recommendations for vaccination schedules and dosing.

Trial Aspect Details
Study Populations Healthy adults, infants, older adults (≥65 years), individuals at increased risk of pneumococcal disease
Key Objectives Evaluate safety, immunogenicity, and effectiveness of pneumococcal vaccines containing serotype 6B
Primary Outcomes Immune responses (antibody levels, OPA titers), adverse events, vaccine effectiveness against pneumococcal infections
Secondary Outcomes Comparisons between vaccine formulations, co-administration effects, long-term protection
Administration Intramuscular injection, single or multiple doses
Safety Monitoring Adverse events, laboratory tests, vital signs
Immunogenicity Measures Serotype-specific antibody levels, opsonophagocytic activity
Effectiveness Endpoints Prevention of invasive pneumococcal disease, pneumonia, other pneumococcal infections

FAQ

  • What is the main purpose of these clinical trials? The main purposes of these trials are to evaluate the safety, immunogenicity, and effectiveness of pneumococcal vaccines containing serotype 6B conjugated to CRM197. They aim to assess immune responses, compare different formulations, and determine the vaccines' ability to prevent pneumococcal infections in various populations.
  • Who are the target populations for these vaccine trials? The trials target various populations, including healthy adults, infants, older adults (65 years and older), and individuals at increased risk of pneumococcal disease. Some studies focus on specific age groups or risk factors.
  • What are some of the key outcomes being measured in these trials? Key outcomes include immune responses (measured by antibody levels and opsonophagocytic activity), safety and tolerability (assessed by adverse events), effectiveness in preventing pneumococcal infections, and comparisons between different vaccine formulations or administration schedules.
  • How is the vaccine typically administered in these trials? The vaccine is typically administered as an intramuscular injection. Some trials investigate single doses, while others look at multiple-dose schedules or co-administration with other vaccines.
  • What are some potential benefits of this pneumococcal vaccine? Potential benefits include protection against pneumococcal infections, which can cause serious illnesses like pneumonia, meningitis, and bloodstream infections. The vaccine may help reduce the burden of disease, especially in vulnerable populations like young children and older adults.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 6B 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 pneumococcal bacteria's outer coating that is used in vaccines to stimulate an immune response against specific serotypes of the 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.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcal bacteria with unique surface polysaccharides.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a stronger antigen (like a protein) to improve the immune response, especially in young children.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • 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.
  • Aluminium phosphate: An adjuvant used in vaccines to enhance the immune response to the vaccine components.
  • 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 extreme values.
  • Vaccine effectiveness: A measure of how well a vaccine prevents a specific outcome (e.g., infection, hospitalization, or death) in real-world conditions.

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/2022-501988-40-00