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

This article examines clinical trials investigating the use of pneumococcal polysaccharide serotype 6A conjugated vaccine, a key component in efforts to prevent pneumococcal infections. These trials aim to evaluate the safety, efficacy, and immune responses of various pneumococcal vaccine formulations containing this serotype, with potential applications in different age groups and populations at risk for pneumococcal disease.

Table of Contents

What is the pneumococcal polysaccharide serotype 6A conjugate vaccine?

The pneumococcal polysaccharide serotype 6A conjugate vaccine is a component of broader pneumococcal vaccines designed to protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 6A serotype[1]. This vaccine is part of conjugate vaccines like Prevenar 13 (PCV13) and Apexxnar (PCV20) that contain multiple pneumococcal serotypes[1].

The full name – “pneumococcal polysaccharide serotype 6A conjugated to CRM197 adsorbed on aluminium phosphate” – describes its key components:

  • Pneumococcal polysaccharide serotype 6A: The outer sugar coating of the 6A strain of pneumococcus
  • Conjugated to CRM197: Attached to a non-toxic variant of diphtheria toxin to enhance immune response
  • Adsorbed on aluminium phosphate: An adjuvant to further boost immune response

How does it work?

This vaccine works by stimulating the immune system to produce antibodies against the 6A serotype of Streptococcus pneumoniae. The conjugation to CRM197 and adsorption on aluminium phosphate help to create a stronger, longer-lasting immune response, especially in young children[1].

When vaccinated individuals encounter the real 6A serotype pneumococcus bacteria, their immune system is primed to recognize and fight off the infection more effectively.

What diseases does it help prevent?

As part of broader pneumococcal vaccines, this component helps protect against various diseases caused by the 6A serotype of Streptococcus pneumoniae, including:

  • Pneumonia (lung infection)
  • Bacteremia (blood infection)
  • Meningitis (infection of the membranes covering the brain and spinal cord)
  • Otitis media (middle ear infection)

Who should get this vaccine?

This vaccine component is typically included in pneumococcal conjugate vaccines recommended for:

  • Infants and young children as part of their routine vaccination schedule
  • Adults 65 years and older
  • Individuals with certain medical conditions that increase their risk of pneumococcal disease

Specific recommendations may vary by country and individual health status. Always consult with a healthcare provider for personalized advice[2].

How is it administered?

The pneumococcal polysaccharide serotype 6A conjugate vaccine is administered as part of broader pneumococcal vaccines like PCV13 or PCV20. It is given as an intramuscular injection, typically in the thigh for infants or the upper arm for older children and adults[2].

The number of doses and schedule can vary depending on the age at which vaccination begins and individual health factors. A common schedule for infants includes:

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

Safety and efficacy

Clinical trials have shown pneumococcal conjugate vaccines containing the 6A serotype to be safe and effective in preventing invasive pneumococcal disease caused by the included serotypes[3]. The conjugation technology used in these vaccines has significantly improved their efficacy compared to older polysaccharide vaccines, especially in young children.

Studies have demonstrated that these vaccines can reduce the incidence of invasive pneumococcal disease, pneumonia, and otitis media caused by the vaccine serotypes[3].

Potential side effects

Like all vaccines, pneumococcal conjugate vaccines can cause side effects, although not everyone experiences them. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability (in infants and young children)
  • Decreased appetite
  • Fatigue

Serious side effects are rare but can include severe allergic reactions. If you experience any concerning symptoms after vaccination, contact your healthcare provider immediately[4].

Ongoing research

Research continues to evaluate the long-term effectiveness of pneumococcal conjugate vaccines and their impact on pneumococcal disease rates. Studies are also investigating the potential need for additional booster doses in certain populations and the development of next-generation pneumococcal vaccines that may provide broader protection against more serotypes[4].

One ongoing study is examining the effectiveness of a 20-valent pneumococcal conjugate vaccine (which includes the 6A serotype) in preventing vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older[5].

Aspect Details
Vaccine Formulations Various pneumococcal conjugate vaccines containing serotype 6A, including 13-valent and 20-valent formulations
Study Populations Healthy adults, older adults (≥65 years), infants, individuals at increased risk of pneumococcal disease
Primary Objectives Evaluate safety, tolerability, immunogenicity, and effectiveness of vaccines
Key Outcome Measures Antibody levels, opsonophagocytic activity, adverse events, vaccine effectiveness against pneumococcal infections
Study Designs Randomized controlled trials, open-label studies, observational studies
Comparators Existing pneumococcal vaccines, placebo, or no vaccination (in some observational studies)
Duration Varies by study, ranging from short-term immunogenicity assessments to long-term effectiveness evaluations
Special Considerations Co-administration with other vaccines, effectiveness in specific risk groups, impact on pneumonia rates

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these trials is to evaluate the safety, efficacy, and immune responses of pneumococcal vaccines containing serotype 6A conjugated to CRM197 and adsorbed on aluminum phosphate. They aim to assess the vaccines' ability to protect against pneumococcal infections in various populations.
  • Who are the target populations for these vaccine trials? The trials target various populations, including healthy adults, older adults (65 years and older), infants, and individuals at increased risk of pneumococcal disease. Some studies focus on specific age groups or risk factors to determine the vaccine's effectiveness in different populations.
  • What are some of the key outcomes being measured in these trials? Key outcomes include safety and tolerability of the vaccines, immune responses measured by antibody levels and opsonophagocytic activity, effectiveness against pneumococcal infections, and in some cases, the impact on pneumonia rates or other clinical endpoints.
  • How do these trials compare different pneumococcal vaccine formulations? Some trials compare newer vaccine formulations (like 20-valent vaccines) to existing vaccines (like 13-valent vaccines) or evaluate the co-administration of pneumococcal vaccines with other vaccines. They assess factors such as immune responses, safety profiles, and effectiveness against various pneumococcal serotypes.
  • What potential benefits could result from these clinical trials? These trials could lead to improved pneumococcal vaccines with broader coverage against different serotypes, better understanding of vaccine effectiveness in various populations, and potentially new vaccination strategies to prevent pneumococcal diseases more effectively across different age groups and risk categories.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 6A 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 serotype 6A: A specific type of pneumococcal bacteria identified by its unique sugar coating (polysaccharide). It is one of the strains included in some pneumococcal vaccines to provide protection against infections caused by this particular serotype.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines. It helps to enhance the immune response to the vaccine, especially in young children.
  • Adsorbed on aluminum phosphate: A process where the vaccine components are attached to aluminum phosphate, which acts as an adjuvant to boost the immune response to the vaccine.
  • Opsonophagocytic activity (OPA): A measure of the functional antibody response to pneumococcal vaccines. It assesses the ability of antibodies to facilitate the uptake and killing of pneumococcal bacteria by immune cells.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface. In the context of pneumococcal vaccines, different serotypes refer to distinct strains of pneumococcal bacteria targeted by the vaccine.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a strong antigen (like a protein) to improve the immune response, especially in young children and older adults.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body. In these trials, it often refers to the vaccine's ability to stimulate the production of protective antibodies.
  • Geometric mean titer (GMT): A measure of the average antibody level in a group of vaccinated individuals, calculated using the geometric mean to account for the typically skewed distribution of antibody levels.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often a focus of studies evaluating the effectiveness of pneumococcal vaccines in preventing serious infections.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome (like infection or disease) in real-world conditions, often expressed as a percentage reduction in risk among vaccinated compared to unvaccinated individuals.

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