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Pneumococcal Polysaccharide Serotype 6A Conjugated To Crm197

This article examines clinical trials investigating the use of pneumococcal polysaccharide serotype 6A conjugated to CRM197 vaccine. This vaccine is part of broader pneumococcal conjugate vaccines being studied to prevent pneumococcal disease in various populations. The trials evaluate the safety, immune response, and effectiveness of these vaccines in different age groups and risk populations.

Table of Contents

What is the pneumococcal polysaccharide serotype 6A conjugate vaccine?

The pneumococcal polysaccharide serotype 6A conjugate vaccine is a component of newer pneumococcal vaccines that help protect against infections caused by the bacterium Streptococcus pneumoniae (pneumococcus). Specifically, this vaccine targets the 6A serotype of pneumococcus.[1]

This vaccine is made by taking part of the outer coating (polysaccharide) of the 6A pneumococcus bacteria and attaching (conjugating) it to a harmless protein called CRM197. The vaccine also contains aluminum phosphate, which helps boost the immune response.[2]

How does it work?

When given as a vaccine, the 6A pneumococcal polysaccharide conjugated to CRM197 stimulates the immune system to produce antibodies against the 6A serotype of pneumococcus. This prepares the body to fight off future infections from this specific strain of bacteria.

The conjugation to the CRM197 protein is important because it helps create a stronger, longer-lasting immune response, especially in young children whose immune systems are still developing.[3]

What diseases does it help prevent?

This vaccine component helps prevent infections caused by the 6A serotype of Streptococcus pneumoniae. These infections can include:

  • Pneumonia – an infection of the lungs
  • Bacteremia – a blood infection
  • Meningitis – an infection of the lining of the brain and spinal cord
  • Otitis media – middle ear infections

Pneumococcal infections can range from mild to very severe and can be life-threatening, especially in young children, older adults, and people with weakened immune systems.[4]

Who should get this vaccine?

The pneumococcal polysaccharide serotype 6A conjugate vaccine is included in newer pneumococcal conjugate vaccines like the 20-valent pneumococcal conjugate vaccine (PCV20). These vaccines are generally recommended for:

  • Infants and young children as part of their routine vaccinations
  • Adults 65 years or older
  • People aged 19-64 with certain medical conditions that increase their risk of pneumococcal disease

Specific recommendations may vary by country and individual risk factors. It’s best to consult with your healthcare provider about whether this vaccine is appropriate for you or your child.[5]

How is it administered?

The pneumococcal polysaccharide serotype 6A conjugate vaccine is given as an injection, usually into the muscle of the upper arm or thigh. It’s typically administered as part of a pneumococcal conjugate vaccine that includes multiple serotypes.

For infants and young children, it’s often given as a series of shots. Adults usually receive a single dose. The exact schedule depends on the specific vaccine product and the person’s age and health status.[1][5]

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing the 6A serotype are effective at preventing infections caused by this strain of pneumococcus. The effectiveness can vary depending on factors like age, overall health, and how long it’s been since vaccination.

In clinical trials, these vaccines have demonstrated good immune responses, with most recipients developing protective antibody levels against the 6A serotype.[3][5]

Is it safe?

Pneumococcal conjugate vaccines, including those containing the 6A serotype, have been extensively studied and are generally considered safe. They have been used in many countries for years and continue to be monitored for safety.

As with any medical treatment, there can be risks, but serious side effects from these vaccines are rare. The benefits of protection against potentially severe pneumococcal infections typically outweigh the risks for recommended individuals.[1][5]

What are the potential side effects?

Most side effects from pneumococcal conjugate vaccines are mild and temporary. Common side effects can include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Irritability (in children)
  • Decreased appetite (in children)
  • Fatigue
  • Headache
  • Muscle pain

Serious allergic reactions are very rare but can occur. If you experience symptoms of a severe allergic reaction (such as difficulty breathing, rapid heartbeat, or dizziness) after vaccination, seek medical attention immediately.[1][5]

Ongoing research

Researchers continue to study pneumococcal conjugate vaccines, including the 6A serotype component, to better understand their long-term effectiveness and safety. Current studies are looking at:

  • The vaccine’s effectiveness in different populations
  • The duration of protection
  • The impact on pneumococcal disease rates in communities
  • Potential cross-protection against related pneumococcal serotypes

This ongoing research helps ensure that vaccination strategies can be optimized to provide the best protection against pneumococcal infections.[3][4][5]

Trial Aspect Details
Vaccine Types 20-valent pneumococcal conjugate vaccine (PCV20), 21-valent pneumococcal conjugate vaccine (V116), 13-valent pneumococcal conjugate vaccine (PCV13)
Study Populations Infants, children and adolescents at higher risk, adults 18-64 with risk factors, adults 60+ years
Primary Objectives Safety, tolerability, immunogenicity, vaccine effectiveness
Immune Response Measures Opsonophagocytic activity (OPA), Immunoglobulin G (IgG) levels
Safety Assessments Injection site reactions, systemic reactions, serious adverse events
Comparison Studies New vaccines vs. PCV13, PPSV23, or no vaccination
Special Considerations Co-administration with other vaccines, effectiveness in preventing pneumonia in older adults

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, tolerability, and immunogenicity (immune response) of pneumococcal conjugate vaccines containing serotype 6A in different populations, including adults, children, and those at higher risk for pneumococcal disease.
  • What age groups are being studied in these trials? The trials cover a wide range of age groups, including infants as young as 2 months old, children and adolescents at higher risk for pneumococcal disease, adults aged 18-64 with increased risk factors, and older adults aged 60 years and above.
  • How is the immune response measured in these studies? The immune response is typically measured through blood tests that look at antibody levels, including opsonophagocytic activity (OPA) and immunoglobulin G (IgG) levels specific to the pneumococcal serotypes in the vaccine.
  • What are some of the safety measures being evaluated? Safety measures include monitoring for adverse events such as injection site reactions, systemic reactions, and any serious adverse events. Some studies also look at the tolerability of the vaccine when co-administered with other vaccines.
  • Are these vaccines being compared to existing pneumococcal vaccines? Yes, many of the trials compare the new pneumococcal conjugate vaccines (like the 20-valent or 21-valent versions) to existing vaccines such as the 13-valent pneumococcal conjugate vaccine (PCV13) or the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 6A Conjugated To Crm197

  • Study of Pneumococcal Vaccine Response in Patients Without a Spleen: Comparing Vaccination Before and After Spleen Removal Using PCV20 and PCV21

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany Spain

  • Study on the Safety and Immune Response of a 21-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia Estonia Finland Germany Greece +3

  • Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Poland Spain Sweden

  • Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

    Not recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Pneumococcal polysaccharide serotype 6A: A specific type of pneumococcal bacteria covered by some pneumococcal vaccines. The '6A' refers to a particular variant of the bacteria's outer coating.
  • 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.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a strong antigen (like a protein) to elicit a stronger immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies can help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation, playing a crucial role in the body's immune response to infections.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different types of pneumococcal bacteria based on their surface polysaccharides.
  • Geometric mean titer (GMT): A way of averaging antibody levels in a group of people, often used to measure vaccine-induced immune responses.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Vaccine effectiveness: A measure of how well a vaccine prevents disease in real-world conditions, often studied after a vaccine has been approved and is in use in the general population.

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/