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Pneumococcal Polysaccharide Serotype 9V

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 9V conjugate vaccine, which is a component of various pneumococcal vaccines being studied. The trials aim to evaluate the safety, tolerability, and immune responses elicited by these vaccines in different populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies compare the new vaccine candidates to existing pneumococcal vaccines and examine factors like dosing schedules and co-administration with other vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 9V vaccine?

The pneumococcal polysaccharide serotype 9V vaccine is a component of several pneumococcal vaccines that help protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 9V serotype. This vaccine is part of broader pneumococcal vaccines that target multiple serotypes of the bacteria.[1]

Pneumococcal vaccines containing the 9V serotype are available under brand names like Synflorix, Prevenar 13, and Apexxnar. These vaccines contain multiple pneumococcal serotypes to provide broad protection against pneumococcal diseases.

How does it work?

The vaccine works by stimulating your immune system to produce antibodies against the outer polysaccharide coating of the pneumococcal 9V serotype. When you’re later exposed to this bacteria, your immune system can quickly recognize it and mount a defense, preventing infection.[1]

Specifically, the 9V serotype polysaccharide is conjugated (attached) to a carrier protein called CRM197. This conjugation helps improve the immune response, especially in young children.

Who should get this vaccine?

Pneumococcal vaccines containing the 9V serotype are recommended for:

  • Infants and young children as part of their routine vaccination schedule
  • Adults 65 years and older
  • People with certain medical conditions that increase their risk of pneumococcal disease, such as:
    • Chronic heart, lung, or liver disease
    • Diabetes
    • Weakened immune systems

Your doctor can advise if you should receive a pneumococcal vaccine based on your age, health status, and vaccination history.[2]

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. The number of doses and schedule can vary depending on the specific vaccine and the age at which vaccination begins.[1]

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing the 9V serotype are highly effective at preventing invasive pneumococcal disease caused by this serotype. The effectiveness can vary depending on factors like age and overall health status.

For example, research has demonstrated that these vaccines can reduce the risk of invasive pneumococcal disease caused by vaccine serotypes by over 90% in healthy children.[3]

What are the potential side effects?

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

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

Serious side effects are rare but can include severe allergic reactions. Contact your healthcare provider if you experience any concerning symptoms after vaccination.[2]

Ongoing research

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

  • Developing vaccines that cover more pneumococcal serotypes
  • Studying the long-term effectiveness of existing vaccines
  • Investigating the impact of vaccination on pneumococcal disease rates in different populations
  • Exploring new vaccine technologies and delivery methods

For example, a recent study is evaluating the safety and immune response of a new 20-valent pneumococcal conjugate vaccine (which includes the 9V serotype) in adults aged 60 years and older.[4]

Study Identifier Population Intervention Key Outcomes
2022-501519-15-00 Healthy adults 20-40 years old Pneumococcal vaccination (PCV20) Timing of peak germinal center B cell and T follicular helper cell responses in lymph nodes
2022-501988-40-00 Adults ≥60 years old RSVPreF3 OA vaccine co-administered with PCV20 Non-inferiority of immune responses when vaccines are co-administered vs. given separately
2022-502791-22-01 Adults 18-64 years old at increased risk of pneumococcal disease V116 pneumococcal conjugate vaccine Safety, tolerability, and immunogenicity compared to PPSV23
2022-503144-40-00 Adults ≥50 years old V116 pneumococcal conjugate vaccine Safety, tolerability, and immunogenicity compared to PPSV23
2023-505154-18-00 Healthy toddlers 12-15 months old Monovalent pneumococcal conjugate candidate Safety and immunogenicity as a 2-dose series following PCV10 primary series
2023-506236-32-00 Children and adolescents at increased risk of pneumococcal disease V116 pneumococcal conjugate vaccine Safety, tolerability, and immunogenicity compared to PPSV23

FAQ

  • What is pneumococcal polysaccharide serotype 9V? Pneumococcal polysaccharide serotype 9V is one of the bacterial capsule types found on Streptococcus pneumoniae. It is included as a component in pneumococcal conjugate vaccines to help protect against infections caused by this specific strain of pneumococcus.
  • Who are the main groups being studied in these clinical trials? The trials are studying various groups including healthy adults, children and adolescents, toddlers, and people at increased risk of pneumococcal disease due to conditions like diabetes, chronic liver/lung/heart/kidney disease.
  • What are the main outcomes being measured in these studies? The main outcomes include safety and tolerability (measuring adverse events), immune responses (antibody levels and functional antibody activity), and comparisons of immune responses between new and existing pneumococcal vaccines.
  • How is the immune response to the vaccines measured? Immune responses are typically measured by blood tests looking at antibody levels (IgG concentrations) and functional antibody activity (opsonophagocytic activity or OPA) against the pneumococcal serotypes in the vaccines.
  • Are these vaccines being tested alone or with other vaccines? Some studies are testing the pneumococcal vaccines alone, while others are looking at co-administration with other vaccines like RSV vaccines. The trials aim to ensure the pneumococcal vaccines can be safely and effectively given alongside other routine vaccinations.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 9V

  • 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

  • Serotype: A distinct variation within a species of bacteria or virus, characterized by specific surface structures. For pneumococcus, serotypes are distinguished by differences in their polysaccharide capsule.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen (like a bacterial polysaccharide) to a strong antigen to elicit a stronger immune response, especially in young children.
  • Opsonophagocytic activity (OPA): A laboratory measure of antibody function, specifically the ability of antibodies to facilitate the uptake and killing of bacteria by immune cells.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation, playing a crucial role in antibody-mediated immunity against invading pathogens.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people that reduces the impact of very high or low individual 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.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a protein carrier in conjugate vaccines to enhance the immune response, especially in young children.
  • Pneumococcal conjugate vaccine (PCV): A vaccine that protects against Streptococcus pneumoniae (pneumococcus), containing purified capsular polysaccharides of pneumococcal serotypes conjugated to a carrier protein.
  • Invasive pneumococcal disease (IPD): A severe infection caused by the Streptococcus pneumoniae bacteria where it invades normally sterile sites in the body, such as the blood or cerebrospinal fluid.
  • Reactogenicity: The property of a vaccine to produce common, expected adverse reactions, particularly excessive immunological responses and associated signs and symptoms, e.g. fever and sore arm at injection site.

References

  1. http://clinicaltrials.eu/trial-id/2022-501519-15-00
  2. http://clinicaltrials.eu/trial-id/2022-502791-22-01
  3. http://clinicaltrials.eu/trial-id/2023-505154-18-00
  4. http://clinicaltrials.eu/trial-id/2022-501988-40-00