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Pneumococcal Polysaccharide Serotype 5 Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article examines clinical trials investigating the use of pneumococcal polysaccharide serotype 5 conjugate vaccine, which is part of broader pneumococcal vaccines being studied. These trials aim to evaluate the safety, efficacy, and immune responses of various pneumococcal vaccine formulations in different populations, from infants to older adults. The studies explore aspects such as vaccine effectiveness against pneumonia, co-administration with other vaccines, and long-term protection against pneumococcal disease.

Table of Contents

What is this vaccine?

The pneumococcal polysaccharide serotype 5 conjugated to CRM197 adsorbed on aluminium phosphate vaccine is one component of broader pneumococcal conjugate vaccines like Prevenar 13 and Apexxnar. These vaccines help protect against invasive pneumococcal disease caused by Streptococcus pneumoniae bacteria.[1]

This specific component targets serotype 5 of S. pneumoniae. The vaccine contains parts of the bacterial capsule (polysaccharides) chemically linked (conjugated) to a non-toxic variant of diphtheria toxin called CRM197. This conjugation helps make the vaccine more effective, especially in young children.[2]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the capsule of serotype 5 S. pneumoniae. When exposed to the actual bacteria later, these antibodies help the immune system recognize and fight off the infection more quickly.[1]

The CRM197 protein acts as a carrier, helping to enhance the immune response, particularly in infants and young children whose immune systems are still developing. The aluminium phosphate serves as an adjuvant, further boosting the immune response.[2]

Who is it for?

This vaccine component is included in pneumococcal conjugate vaccines approved for:

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

The exact age recommendations and dosing schedules can vary by country and specific vaccine formulation.[1]

How effective is it?

As part of broader pneumococcal conjugate vaccines, this component helps provide protection against invasive pneumococcal disease caused by serotype 5 S. pneumoniae. Clinical trials have shown these vaccines to be highly effective at preventing severe infections like bacteremia and meningitis.[3]

For example, one study found that the 13-valent pneumococcal conjugate vaccine (which includes this serotype 5 component) was 75% effective at preventing invasive pneumococcal disease caused by vaccine serotypes in adults 65 and older.[3]

Safety and side effects

The pneumococcal conjugate vaccines containing this component have been shown to have a good safety profile in clinical trials. Common side effects may include:[4]

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Fever (more common in children)

Serious allergic reactions are rare but possible. Patients should seek immediate medical attention if they experience symptoms of a severe allergic reaction after vaccination.[4]

How is it given?

This vaccine component is administered as part of a pneumococcal conjugate vaccine given by intramuscular injection, typically in the thigh for infants or the upper arm for older children and adults. The dosing schedule varies by age and specific vaccine:[1]

  • Infants usually receive a series of doses at 2, 4, 6, and 12-15 months of age
  • Adults 65 and older typically receive a single dose
  • People with certain high-risk conditions may need additional doses

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to assess long-term effectiveness, optimal dosing schedules, and potential for broader protection. Some current areas of investigation include:[5]

  • Evaluating the effectiveness of newer 20-valent pneumococcal conjugate vaccines
  • Studying co-administration with other vaccines
  • Assessing the impact on pneumococcal carriage and herd immunity
  • Monitoring for potential serotype replacement

Patients interested in participating in pneumococcal vaccine research may be able to join clinical trials. Your healthcare provider can provide more information about any ongoing studies you may be eligible for.[5]

Aspect Details
Vaccine Types 20-valent pneumococcal conjugate vaccine (PCV20), 13-valent pneumococcal conjugate vaccine (PCV13), investigational pneumococcal vaccines
Study Populations Healthy infants, adults aged 18-64 at increased risk, adults aged 65 and older, patients with specific conditions (e.g., multiple sclerosis, multiple myeloma)
Primary Objectives Safety and tolerability, immunogenicity, efficacy against pneumococcal disease
Key Outcome Measures Antibody levels, opsonophagocytic activity (OPA) titers, adverse events, vaccine effectiveness against pneumonia
Study Designs Randomized controlled trials, open-label studies, test-negative design for effectiveness studies
Co-administration Studies Some trials evaluate co-administration with other vaccines (e.g., RSV vaccine)
Long-term Assessments Several studies include long-term follow-up to assess duration of protection and safety

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, efficacy, and immune responses of pneumococcal vaccines containing serotype 5 conjugate, along with other serotypes. The trials aim to assess how well these vaccines protect against pneumococcal diseases in various age groups and populations.
  • Who are the target populations for these vaccine trials? The target populations vary across the trials but include healthy infants, adults aged 18-64 with increased risk of pneumococcal disease, and older adults aged 65 and above. Some trials focus on specific groups like those with relapsing multiple sclerosis or multiple myeloma.
  • What are some of the key outcomes being measured in these trials? Key outcomes include vaccine efficacy against pneumonia, immune responses measured by antibody levels, safety and tolerability of the vaccines, and long-term protection. Some trials also look at co-administration with other vaccines and effectiveness in specific medical conditions.
  • How is the safety of the vaccines being evaluated? Safety is evaluated by monitoring adverse events, both local (at injection site) and systemic, following vaccination. This includes tracking the frequency and severity of reactions, as well as any serious adverse events that may occur during the study period.
  • What makes these pneumococcal vaccines different from previous versions? These trials are investigating newer formulations of pneumococcal vaccines that include a broader range of serotypes, such as 20-valent versions. They aim to provide wider protection against pneumococcal diseases compared to earlier vaccines, and some explore novel combinations or administration schedules.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 5 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. Different serotypes correspond to different variations of this polysaccharide.
  • Serotype: A distinct variation within a species of bacteria or virus, identified by specific antigens on its surface. In pneumococcal vaccines, multiple serotypes are often included to provide broader protection.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a strong antigen to enhance the immune response. In pneumococcal vaccines, the polysaccharide is often conjugated to a protein carrier like CRM197.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a protein carrier in conjugate vaccines to enhance the immune response, especially in young children.
  • Opsonophagocytic activity (OPA): A measure of the functional antibody response to pneumococcal vaccination, indicating the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body. In these trials, it's often measured by antibody levels or OPA titers.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Relapsing multiple sclerosis (RMS): A form of multiple sclerosis characterized by clearly defined attacks of new or increasing neurologic symptoms, followed by periods of partial or complete recovery.
  • Multiple myeloma: A cancer of plasma cells, a type of white blood cell that normally produces antibodies to help fight infections.
  • Translocation (11;14): A genetic abnormality found in some multiple myeloma cases, where parts of chromosomes 11 and 14 switch places, potentially affecting disease characteristics and treatment response.

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-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/