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Pneumococcal Polysaccharide Serotype 33F Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article discusses clinical trials involving the pneumococcal polysaccharide serotype 33F conjugate vaccine, which is part of a 20-valent pneumococcal conjugate vaccine (20vPnC). These trials aim to study the vaccine’s immune responses, effectiveness, and safety in various populations. The studies range from investigating vaccine-induced immunity mechanisms to evaluating its real-world effectiveness against pneumococcal diseases, particularly in older adults. The trials provide valuable insights into the potential benefits and applications of this vaccine component in preventing pneumococcal infections.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197?

Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197 Adsorbed on Aluminium Phosphate is a component of a vaccine called Apexxnar. This vaccine is designed to protect against infections caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus.[1]

To break down this complex name:

  • Pneumococcal Polysaccharide: This refers to a sugar molecule from the outer coating of the pneumococcus bacteria.
  • Serotype 33F: This identifies a specific strain of pneumococcus that the vaccine targets.
  • Conjugated to CRM197: The bacterial sugar is attached (conjugated) to a carrier protein called CRM197, which helps boost the immune response.
  • Adsorbed on Aluminium Phosphate: The vaccine components are attached to aluminum phosphate, which acts as an adjuvant to further enhance the immune response.

How Does It Work?

This vaccine works by stimulating your immune system to produce antibodies against the pneumococcal bacteria. When your body is exposed to the harmless parts of the bacteria in the vaccine, it learns to recognize and fight against them. If you later encounter the actual bacteria, your immune system is prepared to respond quickly and effectively.[2]

Medical Uses

Apexxnar, which contains this component, is used to prevent pneumococcal diseases in adults aged 65 years and older. These diseases can include:

  • Pneumonia (a serious lung infection)
  • Bacteremia (infection in the bloodstream)
  • Meningitis (infection of the lining of the brain and spinal cord)

The vaccine is particularly important for older adults and those with certain chronic medical conditions, as they are at higher risk for severe pneumococcal infections.[3]

How is It Administered?

Apexxnar is given as an intramuscular injection, typically in the upper arm. For most adults, a single dose of 0.5 ml is recommended. The vaccine is usually administered by a healthcare professional in a clinical setting.[1]

Clinical Studies and Effectiveness

Several clinical studies have been conducted to evaluate the effectiveness of Apexxnar, which includes the Pneumococcal Polysaccharide Serotype 33F component:

  • A study is being conducted to determine the effectiveness of the 20-valent pneumococcal conjugate vaccine (which includes serotype 33F) against vaccine-type radiologically-confirmed community-acquired pneumonia in adults aged 65 and older.[3]
  • Another study is evaluating the immune response, safety, and reactogenicity when the pneumococcal vaccine is co-administered with an RSV vaccine in adults aged 60 years and older.[2]

These studies aim to provide more information about how well the vaccine works in real-world settings and how it interacts with other vaccines.

Safety Profile

The safety of Apexxnar is being closely monitored in clinical trials. Common side effects may include:

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

Serious allergic reactions are rare but possible. It’s important to discuss any concerns or medical conditions with your healthcare provider before receiving the vaccine.[2]

Important Considerations for Patients

If you’re considering or scheduled to receive this vaccine, keep in mind:

  • Inform your healthcare provider about any allergies, especially to vaccine components.
  • Discuss your medical history, including any immune system problems or recent vaccinations.
  • The vaccine may be given at the same time as other vaccines, such as the flu shot, but this should be discussed with your doctor.[2]
  • While the vaccine significantly reduces the risk of pneumococcal disease, it doesn’t guarantee complete protection. Maintaining good overall health and hygiene practices remains important.

Remember, vaccines like Apexxnar play a crucial role in preventing serious infections, especially in vulnerable populations. If you have any questions or concerns, don’t hesitate to discuss them with your healthcare provider.

Aspect Details
Vaccine Composition 20-valent pneumococcal conjugate vaccine (20vPnC) including serotype 33F
Main Study Populations Healthy adults, adults aged 60+ years, adults aged 65+ years
Key Objectives Evaluate immune responses, vaccine effectiveness, safety, and co-administration with other vaccines
Primary Outcomes Antibody titers, opsonophagocytic activity, prevention of community-acquired pneumonia
Safety Monitoring Adverse events, reactogenicity, serious adverse events
Study Designs Randomized controlled trials, test-negative design for effectiveness study
Unique Aspects Evaluation of co-administration with RSV vaccine, real-world effectiveness study

FAQ

  • What is the main purpose of the pneumococcal polysaccharide serotype 33F conjugate vaccine? The pneumococcal polysaccharide serotype 33F conjugate vaccine is part of a 20-valent pneumococcal conjugate vaccine (20vPnC) designed to prevent infections caused by Streptococcus pneumoniae bacteria, particularly those of serotype 33F. It aims to stimulate the immune system to produce antibodies against this specific serotype, providing protection against pneumococcal diseases such as pneumonia, meningitis, and bloodstream infections.
  • Who are the main target groups for these clinical trials? The clinical trials target various groups, including healthy volunteers and older adults. One study focuses on adults aged 60 years and older, while another specifically includes participants 65 years of age and older. These age groups are particularly important as they are at higher risk for severe pneumococcal infections.
  • What are some of the key outcomes being measured in these trials? The trials measure several key outcomes, including immune responses (such as antibody levels and opsonophagocytic activity), vaccine effectiveness against pneumococcal diseases (particularly community-acquired pneumonia), safety and reactogenicity of the vaccine, and the impact of co-administration with other vaccines like the RSV vaccine.
  • How is the effectiveness of the vaccine being evaluated? The vaccine's effectiveness is being evaluated through various methods, including measuring antibody responses, assessing opsonophagocytic activity (which indicates the ability of antibodies to facilitate bacterial killing), and conducting real-world studies to determine the vaccine's impact on preventing pneumococcal diseases in vaccinated individuals compared to unvaccinated controls.
  • Are there any specific safety concerns being monitored in these trials? Yes, safety is a crucial aspect of these trials. Researchers are monitoring for adverse events, including local and systemic reactions to the vaccine. This includes tracking solicited events within 7 days of vaccination, unsolicited adverse events within 30 days, and serious adverse events throughout the study period. The trials also assess the safety of co-administering the pneumococcal vaccine with other vaccines.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 33F 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

  • 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

  • Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland Spain

Glossary

  • Pneumococcal polysaccharide serotype 33F: A specific type of sugar molecule (polysaccharide) found on the surface of certain strains of Streptococcus pneumoniae bacteria. It is one of the serotypes included in the 20-valent pneumococcal conjugate vaccine.
  • 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 polysaccharide antigens in the vaccine.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates the ability of vaccine-induced antibodies to facilitate the uptake and killing of bacteria by immune cells.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, typically in the general community. It is a common and potentially serious infection, especially in older adults.
  • 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 Streptococcus pneumoniae.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a strong antigen (like a protein) to elicit a stronger 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.
  • Reactogenicity: The capacity of a vaccine to produce common, expected adverse reactions, particularly excessive immunological responses and associated signs and symptoms, such as fever and soreness at the injection site.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents a specific outcome (e.g., disease or infection) in the real world, typically expressed as a percentage reduction in disease incidence in vaccinated groups compared to unvaccinated groups.
  • RSV (Respiratory Syncytial Virus): A common respiratory virus that usually causes mild, cold-like symptoms but can be serious, especially for infants and older adults. Some trials are studying the co-administration of pneumococcal and RSV vaccines.

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