Pneumococcal Polysaccharide Serotype 6B

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 6B conjugate vaccine. These trials aim to evaluate the safety, tolerability, and immune responses elicited by various pneumococcal conjugate vaccine formulations containing serotype 6B, either alone or in combination with other serotypes. The studies involve different populations, including healthy adults, children, and those at increased risk of pneumococcal disease.

Table of Contents

What is Pneumococcal Polysaccharide Serotype 6B?

Pneumococcal polysaccharide serotype 6B is a component of several pneumococcal vaccines. It is one of many serotypes (variants) of the bacterium Streptococcus pneumoniae, also known as pneumococcus. This bacterium can cause various infections, including pneumonia, meningitis, and bloodstream infections.[1]

Pneumococcal disease refers to any infection caused by Streptococcus pneumoniae bacteria. These infections can range from mild to severe and can be life-threatening, especially in young children, older adults, and people with weakened immune systems.

How the Vaccine Works

The pneumococcal polysaccharide serotype 6B vaccine works by stimulating your immune system to produce antibodies against this specific type of pneumococcal bacteria. When the vaccine is injected, your body recognizes the inactivated bacterial components as foreign and creates antibodies to fight them. This prepares your immune system to respond quickly if you’re ever exposed to the actual bacteria in the future.

In many pneumococcal vaccines, the serotype 6B component is conjugated to a carrier protein. This means it’s chemically linked to another protein, which helps enhance the immune response, especially in young children. Common carrier proteins include CRM197 (a non-toxic variant of diphtheria toxin) and protein D (derived from non-typeable Haemophilus influenzae).[2]

Who Needs This Vaccine?

Pneumococcal vaccines containing serotype 6B are recommended for several groups:

  • 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
    • Cochlear implants or cerebrospinal fluid leaks

Your healthcare provider can advise you on whether you need this vaccine based on your age, health status, and vaccination history.[3]

How is it Administered?

The pneumococcal polysaccharide serotype 6B vaccine is typically administered as an intramuscular injection, usually in the upper arm for adults or the thigh for infants. It’s often given as part of a combination vaccine that protects against multiple pneumococcal serotypes.

The number of doses and timing can vary depending on the specific vaccine and the person’s age and health status. For example, infants might receive a series of doses as part of their routine vaccinations, while adults might only need a single dose or a booster after several years.[4]

Safety and Side Effects

Pneumococcal vaccines containing serotype 6B have been extensively studied and are generally considered safe. Like all vaccines, they can cause some side effects, but serious reactions are rare. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Fatigue
  • Muscle aches

These side effects usually resolve within a few days. Severe allergic reactions are very rare but can occur with any vaccine. If you experience any severe symptoms after vaccination, seek medical attention immediately.[5]

Effectiveness

Pneumococcal vaccines that include serotype 6B have been shown to be effective in reducing the incidence of invasive pneumococcal disease caused by this serotype. The effectiveness can vary depending on factors such as age, overall health, and the specific vaccine used.

It’s important to note that while the vaccine provides protection against serotype 6B and other included serotypes, it doesn’t protect against all types of pneumococcal bacteria. However, by protecting against common and often more severe serotypes, these vaccines significantly reduce the overall risk of pneumococcal disease.[6]

Ongoing Research

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

  • Developing vaccines that protect against more serotypes
  • Improving vaccine effectiveness in specific populations, such as the elderly or immunocompromised individuals
  • Studying the long-term effectiveness and need for booster doses
  • Monitoring the impact of vaccination on pneumococcal disease rates and potential changes in circulating serotypes

These ongoing studies help ensure that pneumococcal vaccines, including those containing serotype 6B, continue to provide optimal protection against pneumococcal disease.[7]

Study Identifier Population Intervention Primary Endpoints
2022-501519-15-00 Healthy volunteers aged 20-40 Pneumococcal vaccination (Apexxnar or Prevenar 13) Percentage of germinal center B cells in lymph node aspirates
2022-501988-40-00 Adults aged 60 years and older RSVPreF3 OA vaccine co-administered with PCV20 Opsonophagocytic antibody titers, RSV-A and RSV-B neutralizing antibody titers
2022-502791-22-01 Adults aged 18-64 at increased risk of pneumococcal disease V116 pneumococcal conjugate vaccine Adverse events, opsonophagocytic antibody titers
2022-503144-40-00 Adults aged 50 years or older V116 pneumococcal conjugate vaccine Adverse events, opsonophagocytic antibody titers
2023-505154-18-00 Healthy toddlers aged 11-15 months Monovalent pneumococcal conjugate candidate Local reactions, systemic events, adverse events, opsonophagocytic activity titers
2023-506236-32-00 Children and adolescents at increased risk of pneumococcal disease V116 pneumococcal conjugate vaccine Adverse events, opsonophagocytic antibody titers

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 6B

  • 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
    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
    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
    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
    Denmark

Glossary

  • Serotype: A distinct variation within a species of bacteria or virus, characterized by specific surface structures. In pneumococcus, serotypes are distinguished by differences in their polysaccharide capsule.
  • Conjugate vaccine: A type of vaccine that combines a weak antigen (like a polysaccharide) with a strong antigen to improve the immune response, especially in young children.
  • Opsonophagocytic activity (OPA): A laboratory test that measures the functional ability of antibodies to facilitate the uptake and killing of bacteria by immune cells. It's used to assess the effectiveness of pneumococcal vaccines.
  • Immunoglobulin G (IgG): The most common type of antibody found in blood circulation. Measuring IgG levels helps assess the strength of the immune response to vaccination.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of individuals, useful for comparing immune responses between different vaccines or populations.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Polysaccharide: A type of carbohydrate consisting of a large number of sugar molecules bonded together. In pneumococcal bacteria, the capsular polysaccharide is a key target for vaccines.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response to polysaccharide antigens.
  • Invasive pneumococcal disease (IPD): A severe infection caused by Streptococcus pneumoniae bacteria in normally sterile sites of the body, such as the blood or cerebrospinal fluid.

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/2023-503144-40-00
  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