Pneumococcal Polysaccharide Serotype 7F

This article examines clinical trials investigating the use of pneumococcal polysaccharide serotype 7F as a component in pneumococcal vaccines. These trials aim to evaluate the safety, tolerability, and immune responses generated by vaccines containing this serotype in various populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The research seeks to improve protection against pneumococcal infections through new and enhanced vaccine formulations.

Table of Contents

What is pneumococcal polysaccharide serotype 7F?

Pneumococcal polysaccharide serotype 7F is one of the components found in certain pneumococcal vaccines. It helps protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 7F serotype.[1] This bacteria can cause serious illnesses like pneumonia, meningitis, and bloodstream infections, especially in young children, older adults, and people with weakened immune systems.

The 7F serotype is included in several pneumococcal conjugate vaccines, including:

  • Synflorix – A 10-valent vaccine that protects against 10 serotypes including 7F[2]
  • Prevenar 13 – A 13-valent vaccine covering 13 serotypes including 7F[1]
  • Apexxnar – A 20-valent vaccine protecting against 20 serotypes including 7F[1]

How does the vaccine work?

The pneumococcal polysaccharide serotype 7F vaccine works by stimulating the body’s immune system to produce antibodies against the outer coating (polysaccharide) of the 7F serotype of pneumococcal bacteria. This prepares the immune system to recognize and fight off this specific strain if exposed in the future.[1]

In conjugate vaccines, the 7F polysaccharide is chemically linked (conjugated) to a carrier protein. This enhances the immune response, especially in young children. Common carrier proteins used include:

  • CRM197 (a non-toxic variant of diphtheria toxin)
  • Protein D (derived from non-typeable Haemophilus influenzae)

This conjugation process helps create a stronger, longer-lasting immune response compared to unconjugated polysaccharide vaccines.[2]

Who should get vaccinated?

Pneumococcal vaccines containing the 7F serotype are generally recommended for:

  • Infants and young children as part of routine childhood immunizations
  • Adults 65 years and older
  • People with certain medical conditions that increase the risk of pneumococcal disease, such as:
    • Chronic heart, lung, or liver disease
    • Diabetes
    • Weakened immune system
    • Cochlear implants
    • Cerebrospinal fluid leaks

The specific recommendations may vary depending on age, health status, and previous vaccination history. It’s best to consult with a healthcare provider to determine the appropriate vaccination schedule.[3]

Effectiveness

Studies have shown that pneumococcal conjugate vaccines containing serotype 7F are effective at preventing invasive pneumococcal disease caused by this strain. For example:

  • A study on the 13-valent pneumococcal conjugate vaccine (which includes 7F) found it to be 75% effective against invasive pneumococcal disease caused by vaccine serotypes in adults 65 years and older.[4]
  • Research on the 10-valent pneumococcal conjugate vaccine showed high effectiveness against invasive pneumococcal disease caused by vaccine serotypes, including 7F, in children.[2]

The effectiveness can vary depending on factors like age, immune status, and time since vaccination. Booster doses may be recommended to maintain protection over time.

Safety and side effects

Pneumococcal vaccines containing serotype 7F have been shown to have a good safety profile. However, like all vaccines, they can cause some side effects. Common side effects may include:

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

These side effects are usually mild and resolve on their own within a few days. Serious allergic reactions are rare but can occur. It’s important to discuss any concerns or medical conditions with a healthcare provider before receiving the vaccine.[3]

How is it administered?

Pneumococcal vaccines containing serotype 7F are typically administered as an intramuscular injection, usually in the thigh for infants or the upper arm for older children and adults. The number of doses and timing can vary depending on the specific vaccine and the person’s age and health status.

For example:

  • Infants may receive a series of doses starting at 2 months of age, with boosters in early childhood
  • Adults 65 and older may receive a single dose or a series of two different pneumococcal vaccines
  • People with certain health conditions may have different schedules

A healthcare provider can provide specific guidance on the appropriate vaccination schedule based on individual circumstances.[5]

Aspect Details
Vaccine Types Various pneumococcal conjugate vaccines containing serotype 7F, including V116, PCV20, and experimental formulations
Study Populations Healthy adults, children, adolescents, toddlers, and individuals at increased risk of pneumococcal disease
Primary Objectives Evaluate safety, tolerability, and immunogenicity of vaccines containing serotype 7F
Key Measurements Opsonophagocytic activity (OPA), Immunoglobulin G (IgG) levels, adverse events
Comparison Vaccines PPSV23, PCV15, existing pneumococcal vaccines
Trial Phases Primarily Phase 2 and Phase 3 studies
Administration Routes Intramuscular injection
Follow-up Periods Varying durations, typically including assessments at 30 days post-vaccination and longer-term safety monitoring

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 7F

  • Study of pneumococcal vaccines in healthy young adults, older adults and people with HIV infection

    Recruiting

    3 1 1 1
    Investigated diseases:
    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
    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:
    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
    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 diseases:
    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:
    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
    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 diseases:
    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 diseases:
    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 diseases:
    Denmark

Glossary

  • Pneumococcal polysaccharide: A sugar-based coating found on pneumococcal bacteria that helps the immune system recognize and fight the bacteria.
  • Serotype: A distinct variation within a species of bacteria, identified by the specific antigens on its surface.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen with a strong antigen to improve the immune response, especially in young children.
  • Opsonophagocytic activity (OPA): A laboratory test that measures how well antibodies help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood and other body fluids, which protects against bacterial and viral infections.
  • Geometric mean titer (GMT): A way of averaging the amount of antibodies in a group of samples, used to compare immune responses between different vaccines or groups.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.
  • CRM197: A non-toxic form of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance immune response.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Pneumococcal disease: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, meningitis, and bloodstream infections.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2023-505154-18-00
  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/2023-506236-32-00