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Pneumococcal Polysaccharide Serotype 14

This article summarizes key clinical trials investigating the safety and efficacy of pneumococcal vaccines containing polysaccharide serotype 14, an important component in preventing pneumococcal infections. The trials examine various pneumococcal vaccine formulations in different populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies aim to evaluate immune responses, safety profiles, and potential for disease prevention across age groups.

Table of Contents

What is the pneumococcal polysaccharide serotype 14 vaccine?

The pneumococcal polysaccharide serotype 14 vaccine is a component of broader pneumococcal vaccines that help protect against infections caused by the Streptococcus pneumoniae bacteria, also known as pneumococcus. This particular serotype (type 14) is one of many pneumococcal strains that can cause serious illnesses.[1]

Pneumococcal vaccines containing serotype 14 are often referred to by brand names like Prevnar 13, Prevenar 13, Synflorix, or Apexxnar, depending on the specific formulation. These vaccines may protect against multiple pneumococcal serotypes, including type 14.[2]

How does it work?

The vaccine works by introducing a small amount of the outer coating (polysaccharide) of the pneumococcal bacteria into your body. This coating is specific to serotype 14. Your immune system recognizes this as foreign and produces antibodies against it. If you’re later exposed to the actual pneumococcus bacteria of this serotype, your body can quickly recognize and fight off the infection.[3]

In many pneumococcal vaccines, the polysaccharide is attached (conjugated) to a harmless protein. This process, called conjugation, helps improve the immune response, especially in young children.[4]

Who needs this vaccine?

Pneumococcal vaccines containing serotype 14 are recommended for several groups:

  • All children under 2 years old
  • Adults 65 years and older
  • People with certain medical conditions that increase their risk of pneumococcal disease, such as:
    • Chronic heart, lung, or liver diseases
    • Diabetes
    • Weakened immune systems

Your healthcare provider can advise if you or your child should receive this vaccine based on age, health status, and previous vaccinations.[5]

What are the benefits?

Vaccination against pneumococcal serotype 14 can help prevent serious infections caused by this strain, including:

  • 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 (especially in children)

These infections can be life-threatening, particularly in young children, older adults, and people with weakened immune systems. By getting vaccinated, you reduce your risk of these serious illnesses.[6]

Is it safe?

Pneumococcal vaccines, including those containing serotype 14, have been extensively studied and are considered very safe. They have been used for many years in millions of people worldwide. The benefits of protection against pneumococcal disease far outweigh the small risk of side effects for most people.[7]

What are the potential side effects?

Most side effects of pneumococcal vaccines are mild and go away on their own within a few days. Common side effects may include:

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

Serious allergic reactions are very rare but can occur. Seek immediate medical attention if you experience difficulty breathing, rapid heartbeat, dizziness, or severe swelling after receiving the vaccine.[1]

How is it administered?

The pneumococcal vaccine containing serotype 14 is typically given as an injection into the muscle (intramuscular). For infants, it’s usually injected into the thigh muscle. For older children and adults, it’s often given in the upper arm.

The number of doses and timing can vary depending on the specific vaccine and the person’s age and health status. For example:

  • Infants usually receive a series of doses starting at 2 months of age
  • Adults 65 and older may receive a single dose
  • People with certain health conditions may need additional doses

Always follow your healthcare provider’s recommendations for vaccination schedules.[2]

Trial Identifier Study Population Intervention Primary Outcomes
2022-501519-15-00 Healthy volunteers aged 20-40 Pneumococcal vaccination (Apexxnar or Prevenar 13) Percentage of germinal centre B cells in lymph node aspirates
2022-501988-40-00 Adults aged 60 years and older RSVPreF3 OA vaccine co-administered with PCV20 Non-inferiority of immune responses when vaccines are co-administered
2022-502791-22-01 Adults 18-64 years with increased pneumococcal disease risk V116 pneumococcal vaccine Safety and opsonophagocytic antibody titers
2022-503144-40-00 Adults 50 years and older V116 pneumococcal vaccine Safety and opsonophagocytic antibody titers compared to PPSV23
2023-505154-18-00 Toddlers 11-15 months old Monovalent pneumococcal conjugate candidate Safety profile and immune responses
2023-506236-32-00 Children and adolescents with increased pneumococcal disease risk V116 pneumococcal vaccine Safety and opsonophagocytic antibody titers compared to PPSV23

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 vaccines containing serotype 14 in various populations, including healthy adults, children, and those at increased risk of pneumococcal disease.
  • What age groups are being studied in these trials? The trials cover a wide range of age groups, including toddlers as young as 11-15 months, children and adolescents at increased risk of pneumococcal disease, adults aged 18-64 with risk factors, and older adults aged 50 years and above.
  • What are the primary outcomes being measured? Primary outcomes include safety measures like adverse events, local reactions at injection sites, and systemic events. Immunogenicity is assessed through measures like opsonophagocytic activity (OPA) titers and antibody concentrations for specific pneumococcal serotypes.
  • Are these vaccines being compared to existing pneumococcal vaccines? Yes, some trials compare new vaccine candidates to existing pneumococcal vaccines like PPSV23 (23-valent pneumococcal polysaccharide vaccine) or PCV15 (15-valent pneumococcal conjugate vaccine) to assess relative safety and immunogenicity.
  • How long do these clinical trials typically last? The duration varies, but many trials involve follow-up periods of several months to assess both short-term reactions and longer-term immune responses. Some studies, like the extension study for patients with C3 glomerulopathy, last up to 120 weeks (about 2.5 years).

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 14

  • 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 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 on Long-Term Kidney Transplant Outcomes in Low-Risk Patients Using Tacrolimus Alone or with Mycophenolate Mofetil

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Not recruiting

    3 1 1
    Investigated drugs:
    Estonia Poland

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

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Germany Spain

  • Study on the Best Time for Influenza Vaccine Administration in Adults Aged 60-85 Using Influenza Vaccine and Drug Combination

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Not recruiting

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

  • Study on Long-Term Safety and Effectiveness of Ofatumumab for Patients with Relapsing Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +15

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

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Finland France Poland Spain Sweden

  • Study on Venetoclax and Dexamethasone for Patients with Relapsed and Refractory Multiple Myeloma with Translocation (11;14)

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Pneumococcal polysaccharide serotype 14: A specific type of polysaccharide (complex sugar) found on the surface of certain pneumococcal bacteria. It is included in pneumococcal vaccines to stimulate immunity against this particular strain.
  • Opsonophagocytic activity (OPA): A laboratory measure of antibody function, specifically the ability of antibodies to facilitate the ingestion and killing of bacteria by immune cells. Higher OPA levels generally indicate better protection against pneumococcal disease.
  • 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.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people that accounts for the typically skewed distribution of titer values. It's calculated by multiplying all values and then taking the nth root, where n is the number of values.
  • 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.
  • Serotype: A distinct variation within a species of bacteria or virus, usually characterized by the presence of specific antigens on the cell surface. Different pneumococcal serotypes can cause different types of infections.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a polysaccharide) to a stronger antigen to elicit a more robust immune response, especially in young children.
  • PPSV23: 23-valent pneumococcal polysaccharide vaccine, a vaccine that provides protection against 23 different serotypes of pneumococcal bacteria.
  • PCV15: 15-valent pneumococcal conjugate vaccine, a vaccine that provides protection against 15 different serotypes of pneumococcal bacteria using the conjugate vaccine technology.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation. IgG levels are often measured to assess immune response to 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-id/2022-502791-22-01
  4. http://clinicaltrials.eu/trial-id/2022-503144-40-00
  5. http://clinicaltrials.eu/trial-id/2023-504625-39-00
  6. http://clinicaltrials.eu/trial-id/2023-505154-18-00
  7. http://clinicaltrials.eu/trial-id/2023-506236-32-00