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Pneumococcal Polysaccharide Serotype 18C Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing serotype 18C polysaccharide conjugated to CRM197 and adsorbed on aluminum phosphate. The vaccine is being studied for prevention of pneumococcal disease in various populations, including healthy adults, infants, and those at increased risk. Key aspects examined include safety, immune responses, and effectiveness against pneumococcal infections when given alone or with other vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 18C conjugate vaccine?

The pneumococcal polysaccharide serotype 18C conjugate vaccine is a component of broader pneumococcal conjugate vaccines that protect against multiple strains of Streptococcus pneumoniae bacteria. Specifically, this vaccine contains the capsular polysaccharide from serotype 18C of S. pneumoniae that is chemically linked (conjugated) to a carrier protein called CRM197.[1]

The vaccine formulation also includes aluminium phosphate as an adjuvant to enhance the immune response. This specific serotype 18C component is included in pneumococcal conjugate vaccines like Prevenar 13 and Apexxnar.[1]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the capsular polysaccharide of the 18C serotype of S. pneumoniae. The key aspects of its mechanism are:

  • The polysaccharide from the bacterial capsule acts as the antigen that triggers an immune response.
  • Conjugation to the CRM197 protein carrier enhances the immune response, especially in infants and young children.
  • The aluminium phosphate adjuvant further boosts the immune system’s reaction.
  • This results in the production of antibodies that can recognize and help neutralize the 18C serotype of pneumococcus if encountered later.[1]

What is it used for?

This vaccine component, as part of broader pneumococcal conjugate vaccines, is used to prevent infections caused by the 18C serotype of S. pneumoniae, including:

  • Invasive pneumococcal disease – like bacteremia and meningitis
  • Pneumonia
  • Otitis media (middle ear infection)

It is particularly important for protecting infants, young children, older adults, and those with certain health conditions that increase their risk of pneumococcal infections.[2]

How is it administered?

The serotype 18C component is given as part of multi-valent pneumococcal conjugate vaccines. Key points about administration include:

  • It is given as an intramuscular injection, typically in the thigh for infants or the upper arm for older children and adults.
  • The dosing schedule varies by age and risk factors, but often includes a primary series in infancy followed by booster doses.
  • For adults, it is usually given as a single dose.
  • The typical dose volume is 0.5 mL.[2]

How effective is it?

As part of pneumococcal conjugate vaccines, the serotype 18C component has shown good effectiveness:

  • It induces a strong antibody response against the 18C serotype in most recipients.
  • Clinical trials have demonstrated high efficacy in preventing invasive disease caused by this serotype.
  • Population studies have shown significant reductions in 18C serotype infections after introduction of conjugate vaccines containing this component.
  • The conjugate form provides better protection than older polysaccharide-only vaccines, especially in young children.[3]

Safety and side effects

The pneumococcal conjugate vaccines containing the 18C serotype component have a good safety profile. Common side effects may include:

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

Serious allergic reactions are rare. The benefits of protection against pneumococcal disease generally outweigh the risks of side effects for recommended individuals.[3]

Who should get vaccinated?

Recommendations for pneumococcal conjugate vaccines containing the 18C serotype component typically include:

  • All infants, starting at 2 months of age
  • Children and adolescents who didn’t receive the vaccine as infants
  • Adults 65 years and older
  • Younger adults with certain medical conditions that increase pneumococcal disease risk
  • Adults who smoke cigarettes

Specific recommendations may vary by country and individual risk factors. Patients should consult their healthcare provider to determine if vaccination is appropriate for them.[4]

Ongoing research

Research continues on pneumococcal vaccines, including those containing the 18C serotype component. Some areas of ongoing study include:

  • Development of next-generation vaccines covering more serotypes
  • Optimizing vaccination schedules for different age groups and populations
  • Long-term effectiveness and the potential need for additional booster doses
  • Impact on pneumococcal disease epidemiology and serotype distribution
  • Combination with other vaccines to reduce the number of required injections[4]

This ongoing research aims to further improve the prevention of pneumococcal infections and optimize vaccination strategies.

Trial Aspect Details
Populations studied Healthy infants, adults 18-64 at increased risk, adults 60+ years
Key objectives Safety, immunogenicity, effectiveness against pneumococcal disease
Vaccine formulations 13-valent, 20-valent pneumococcal conjugate vaccines
Administration Intramuscular injection, 0.5 mL dose
Primary outcomes Antibody responses, adverse events, vaccine effectiveness
Secondary outcomes Co-administration effects, specific population responses
Study designs Randomized controlled, open-label, observational
Notable aspects Real-world effectiveness, co-administration studies, high-risk populations

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immune responses, and effectiveness of pneumococcal vaccines containing serotype 18C for preventing pneumococcal infections in different populations.
  • What age groups are being studied in these trials? The trials are studying various age groups, including infants as young as 2 months old, adults aged 18-64 at increased risk, and older adults aged 60 years and above.
  • How is the vaccine being administered in these studies? The vaccine is being administered as an intramuscular injection, typically in doses of 0.5 mL.
  • What are some of the key outcomes being measured? Key outcomes include immune responses (antibody levels), rates of pneumococcal disease, safety/adverse events, and vaccine effectiveness against pneumonia in real-world settings.
  • Are there any studies looking at giving this vaccine with other vaccines? Yes, some trials are examining co-administration or sequential administration with other vaccines like RSV vaccines or influenza vaccines in older adults.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 18C 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 disease: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, meningitis, and bloodstream infections.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of Streptococcus pneumoniae.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a protein carrier in conjugate vaccines to enhance the immune response.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to increase the immune response.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of antibody function in killing pneumococcal bacteria.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Vaccine effectiveness: A measure of how well a vaccine prevents disease in real-world conditions.
  • Community-acquired pneumonia (CAP): Pneumonia acquired outside of a healthcare setting.

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/study-on-the-effectiveness-of-20-valent-pneumococcal-conjugate-vaccine-for-preventing-pneumonia-in-adults-aged-65-and-older/