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Pneumococcal Polysaccharide Serotype 11A Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article discusses clinical trials investigating the use of a 20-valent pneumococcal conjugate vaccine (20vPnC) in adults. The trials aim to evaluate the vaccine’s effectiveness against pneumococcal disease, particularly community-acquired pneumonia, in older adults. The studies examine immune responses, safety profiles, and real-world effectiveness of the vaccine when administered alone or in combination with other vaccines.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 11A Conjugate Vaccine?

Pneumococcal Polysaccharide Serotype 11A Conjugate Vaccine is a component of a larger vaccine called Apexxnar. This vaccine is designed to protect against various strains of Streptococcus pneumoniae, a bacterium that can cause serious infections[1]. The “11A” in the name refers to a specific type (serotype) of pneumococcal bacteria that this part of the vaccine targets.

How Does It Work?

The vaccine works by stimulating your immune system to produce antibodies against the pneumococcal bacteria. Specifically, it contains a part of the bacterial coating (polysaccharide) from serotype 11A, which is attached (conjugated) to a carrier protein called CRM197. This combination helps your immune system recognize and remember the bacteria better[1]. The vaccine is also adsorbed on aluminum phosphate, which acts as an adjuvant to enhance the immune response[2].

What Diseases Does It Prevent?

This vaccine, as part of the Apexxnar formulation, helps prevent diseases caused by Streptococcus pneumoniae, including:

  • Pneumonia: An infection of the lungs
  • Bacteremia: A blood infection
  • Meningitis: An infection of the lining of the brain and spinal cord

These conditions can be particularly serious in older adults and people with weakened immune systems[3].

How Is It Administered?

The vaccine is given as an intramuscular injection, typically in the upper arm. It’s part of a pre-filled syringe containing a suspension for injection[1]. The usual dose is 0.5 ml, and it’s generally given as a single dose[2].

Effectiveness of the Vaccine

Studies are ongoing to determine the effectiveness of this vaccine. One study aims to evaluate the vaccine’s effectiveness against radiologically-confirmed community-acquired pneumonia in adults aged 65 and older[3]. The researchers will calculate the vaccine effectiveness as a percentage, comparing vaccinated individuals to unvaccinated ones.

Safety and Side Effects

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

  • Pain or tenderness at the injection site
  • Redness or swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain

Serious allergic reactions are rare but possible. If you experience any severe symptoms after vaccination, seek medical attention immediately[2].

Who Should Get the Vaccine?

The Apexxnar vaccine, which includes the Pneumococcal Polysaccharide Serotype 11A Conjugate, is generally recommended for adults aged 65 and older[3]. However, the specific recommendations may vary based on individual health conditions and previous vaccination history. Always consult with your healthcare provider to determine if this vaccine is right for you.

Ongoing Research

Several clinical trials are currently underway to further study this vaccine:

  • A study is examining the immune response to the vaccine in lymph nodes[1].
  • Another trial is investigating the co-administration of this vaccine with an RSV (Respiratory Syncytial Virus) vaccine in older adults[2].
  • A large-scale study is evaluating the vaccine’s effectiveness in preventing pneumonia in adults 65 and older[3].

These ongoing studies will provide more information about the vaccine’s effectiveness, safety, and optimal use in different populations.

Aspect Details
Vaccine 20-valent pneumococcal conjugate vaccine (20vPnC)
Target Population Adults aged 65 years and older
Primary Objectives Evaluate effectiveness against community-acquired pneumonia, assess immune responses, determine safety profile
Study Designs Phase 3 and 4 clinical trials, including test-negative design and co-administration studies
Key Outcomes Vaccine effectiveness, antibody titers, adverse events, effectiveness in various subgroups
Administration 0.5 ml dose via intramuscular injection
Additional Investigations Co-administration with RSV vaccine, effectiveness by age groups and medical conditions

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the effectiveness of the 20-valent pneumococcal conjugate vaccine (20vPnC) in preventing pneumococcal disease, particularly community-acquired pneumonia, in adults aged 65 and older.
  • Who are the participants in these studies? The studies primarily involve adults aged 65 years and older. Some trials also include healthy volunteers aged 60 and above.
  • What are the key outcomes being measured? Key outcomes include vaccine effectiveness against radiologically-confirmed community-acquired pneumonia, immune responses measured by antibody levels, and safety profiles including adverse events.
  • How is the vaccine being administered in these trials? The vaccine is typically administered as a single 0.5 ml dose via intramuscular injection. Some trials are investigating co-administration with other vaccines like the RSV vaccine.
  • What potential benefits are being studied? The trials are examining the vaccine's ability to prevent pneumococcal disease, boost immune responses against multiple pneumococcal serotypes, and provide protection in various populations including those with chronic medical conditions.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 11A 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

  • 20vPnC: 20-valent pneumococcal conjugate vaccine, a vaccine designed to protect against 20 different serotypes of Streptococcus pneumoniae bacteria
  • Community-acquired pneumonia (CAP): A type of pneumonia that is acquired outside of healthcare settings, often caused by various pathogens including Streptococcus pneumoniae
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of Streptococcus pneumoniae
  • Opsonophagocytic (OP) antibody titers: A measure of functional antibodies that can facilitate the ingestion and killing of bacteria by immune cells
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance immune response
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions, often expressed as a percentage
  • Radiologically-confirmed pneumonia: Pneumonia that is confirmed through chest imaging techniques such as X-rays or CT scans
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body
  • Conjugate vaccine: A type of vaccine that combines a weak antigen with a strong antigen to enhance the immune response
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure

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/