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Pneumococcal Polysaccharide Serotype 19A Conjugated To Crm197 Adsorbed On Aluminium Phosphate

This article summarizes clinical trials investigating the use of a pneumococcal vaccine containing pneumococcal polysaccharide serotype 19A conjugated to CRM197 and adsorbed on aluminium phosphate. The vaccine is being studied in various populations including healthy adults, infants, and those at increased risk of pneumococcal disease. The trials aim to evaluate the safety, immunogenicity, and effectiveness of this vaccine formulation against pneumococcal infections.

Table of Contents

What is the pneumococcal polysaccharide serotype 19A conjugate vaccine?

The pneumococcal polysaccharide serotype 19A conjugate vaccine is a component of broader pneumococcal conjugate vaccines like Prevnar 13 and Apexxnar. It specifically targets the 19A serotype of Streptococcus pneumoniae, a bacterium that can cause serious infections.[1]

This vaccine contains purified capsular polysaccharide from the 19A serotype that is chemically linked (conjugated) to a non-toxic variant of diphtheria toxin called CRM197. The conjugate is then adsorbed onto an aluminum phosphate adjuvant to enhance the immune response.[2]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the capsular polysaccharide of the 19A serotype of S. pneumoniae. The conjugation to CRM197 helps to induce a stronger, longer-lasting immune response, especially in young children.[1]

When vaccinated individuals are later exposed to the 19A serotype, their immune system can quickly recognize and neutralize the bacteria, preventing infection or reducing its severity.[3]

What is it used for?

This vaccine component helps protect against invasive pneumococcal disease (IPD) caused by the 19A serotype, including:

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

It is particularly important because the 19A serotype has become more prevalent and is often associated with antibiotic resistance.[4]

How is it administered?

The vaccine is typically given as an intramuscular injection, usually in the thigh for infants or the upper arm for older children and adults. It is administered as part of broader pneumococcal conjugate vaccines that protect against multiple serotypes.[2]

The dosing schedule varies depending on the age at which vaccination begins:

  • Infants usually receive a series of doses at 2, 4, 6, and 12-15 months of age
  • Older children and adults may receive fewer doses, depending on their age and health status

How effective is it?

Clinical trials have shown that pneumococcal conjugate vaccines containing the 19A serotype are highly effective at preventing invasive pneumococcal disease caused by this strain. For example, studies have demonstrated:

  • A significant reduction in IPD cases caused by serotype 19A after the introduction of vaccines containing this component[5]
  • Strong immune responses in both children and adults, with high levels of protective antibodies produced[3]

What are the potential side effects?

Most side effects of pneumococcal conjugate vaccines are mild and short-lived. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fever
  • Irritability in infants
  • Fatigue
  • Headache (in older children and adults)

Serious side effects are rare but can include severe allergic reactions. Patients should seek medical attention if they experience signs of a severe allergic reaction after vaccination.[2]

Who should get this vaccine?

Pneumococcal conjugate vaccines containing the 19A serotype are recommended for:

  • All 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, such as:
    • Chronic heart, lung, or liver disease
    • Diabetes
    • Weakened immune systems

Your healthcare provider can advise if this vaccine is appropriate for you based on your age, health status, and vaccination history.[6]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines to improve their effectiveness and broaden protection. Some areas of ongoing research include:

  • Developing vaccines that cover even more serotypes[7]
  • Studying the long-term effectiveness and impact on pneumococcal disease patterns[8]
  • Investigating the potential for co-administration with other vaccines[2]

These studies aim to further enhance protection against pneumococcal infections and optimize vaccination strategies for different populations.

Trial Aspect Details
Populations studied Healthy adults, infants, adults aged 18-64 with increased risk, adults aged 65+
Vaccine formulations 20-valent pneumococcal conjugate vaccine (PCV20), 13-valent pneumococcal conjugate vaccine (PCV13)
Key outcomes measured Immune responses, safety/tolerability, effectiveness against pneumococcal diseases
Study designs Randomized controlled trials, open-label studies, test-negative design
Duration of follow-up Ranging from several months to 2 years
Comparator vaccines PCV13, 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Special populations Individuals with increased risk of pneumococcal disease, older adults

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immunogenicity, and effectiveness of pneumococcal vaccines containing serotype 19A conjugated to CRM197 in various populations, including healthy adults, infants, and those at increased risk of pneumococcal disease.
  • 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 years, and older adults aged 65 years and above.
  • What are some of the key outcomes being measured? Key outcomes include immune responses (measured by antibody levels and opsonophagocytic activity), safety and tolerability (adverse events), and effectiveness against pneumococcal diseases like community-acquired pneumonia.
  • Are these vaccines being compared to other pneumococcal vaccines? Yes, some trials are comparing the new vaccine formulations to existing pneumococcal vaccines, such as 13-valent pneumococcal conjugate vaccine (PCV13) or 23-valent pneumococcal polysaccharide vaccine (PPSV23).
  • How long do these clinical trials typically last? The duration varies, but many of the trials have follow-up periods ranging from several months to up to 2 years to assess long-term safety and efficacy.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 19A 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 sugar molecule found on the surface of pneumococcus bacteria that helps stimulate an immune response when used in vaccines.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response, especially in young children.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcus bacteria.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to increase the immune response, often used for bacterial diseases.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of antibody function that assesses the ability of 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, often caused by bacteria like pneumococcus.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Geometric mean titer (GMT): A measure of average antibody levels in a group of subjects, calculated using the geometric mean.
  • Aluminium phosphate: An adjuvant added to vaccines to enhance the immune response to the vaccine components.

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/
  5. http://clinicaltrials.eu/trial-id/2023-506449-40-00
  6. http://clinicaltrials.eu/trial-id/2023-507293-40-00
  7. http://clinicaltrials.eu/trial/study-on-long-term-safety-and-effectiveness-of-ofatumumab-for-patients-with-relapsing-multiple-sclerosis/
  8. http://clinicaltrials.eu/trial/study-on-venetoclax-and-dexamethasone-for-patients-with-relapsed-and-refractory-multiple-myeloma-with-translocation-1114/