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Pneumococcal Polysaccharide Serotype 8

This article summarizes several clinical trials investigating the use of pneumococcal polysaccharide serotype 8 conjugate vaccine, a component of broader pneumococcal vaccines, for preventing pneumococcal diseases. The trials examine the safety, immune response, and effectiveness of these vaccines in different populations, including healthy adults, children, and those at increased risk of pneumococcal infection. The studies aim to evaluate new vaccine formulations and compare them to existing pneumococcal vaccines.

Table of Contents

What is the pneumococcal polysaccharide serotype 8 vaccine?

The pneumococcal polysaccharide serotype 8 vaccine is a component of broader pneumococcal vaccines that help protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the serotype 8 strain.[1] This vaccine is typically included as part of multi-valent pneumococcal conjugate vaccines, such as the 20-valent pneumococcal conjugate vaccine (20vPnC), which provides protection against 20 different serotypes of pneumococcal bacteria.[2]

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the pneumococcal polysaccharide serotype 8. This serotype is conjugated to a carrier protein called CRM197 and adsorbed on aluminum phosphate, which helps enhance the immune response.[3] When a person is later exposed to the pneumococcal bacteria of this serotype, their immune system is primed to recognize and fight off the infection more effectively.

Who needs this vaccine?

The pneumococcal vaccine containing serotype 8 is recommended for several groups of people, including:

  • Adults aged 65 years and older
  • Adults aged 18-64 with certain chronic medical conditions or risk factors, such as:
    • Diabetes mellitus
    • Chronic liver disease
    • Chronic lung disease (including asthma)
    • Chronic heart disease
    • Chronic kidney disease
  • Children and adolescents with increased risk of pneumococcal disease

Your healthcare provider can help determine if you or your child should receive this vaccine based on individual risk factors and medical history.[4]

How effective is it?

Studies have shown that pneumococcal conjugate vaccines containing serotype 8 are effective in preventing invasive pneumococcal disease caused by this specific serotype. The effectiveness can vary depending on factors such as age, overall health, and immune system function. In clinical trials, the vaccine has demonstrated the ability to induce a strong immune response against serotype 8, as measured by opsonophagocytic activity (OPA) and immunoglobulin G (IgG) levels.[5]

Is it safe?

The pneumococcal polysaccharide serotype 8 vaccine, as part of multi-valent pneumococcal conjugate vaccines, has been shown to have a good safety profile. These vaccines undergo rigorous testing and are approved by regulatory agencies such as the FDA and EMA before being made available to the public. However, like all vaccines, it can cause side effects in some people.[6]

How is it given?

The vaccine is typically administered as an intramuscular injection, usually in the upper arm for adults or the thigh for young children. It is often given as a single dose, but some individuals may require additional doses based on their age, health status, and previous vaccination history. The standard dose is 0.5 ml.[7]

What are the potential side effects?

Common side effects of pneumococcal vaccines containing serotype 8 may include:

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain
  • Fever
  • Decreased appetite

These side effects are usually mild and resolve within a few days. Serious allergic reactions are rare but can occur. If you experience any severe symptoms after vaccination, seek medical attention immediately.[2]

Ongoing research

Researchers continue to study pneumococcal vaccines, including those containing serotype 8, to improve their effectiveness and understand their long-term impact on public health. Current studies are investigating:

  • The effectiveness of the vaccine in preventing community-acquired pneumonia in adults aged 65 and older
  • The immune response and safety profile in various populations, including children and adults with increased risk of pneumococcal disease
  • The potential need for booster doses in certain populations
  • The impact of the vaccine on reducing antibiotic-resistant pneumococcal infections

These ongoing studies will help inform future vaccination strategies and potentially lead to even more effective pneumococcal vaccines.[7]

Aspect Details
Vaccine Types Pneumococcal conjugate vaccines including serotype 8 (e.g., 20-valent PCV, V116)
Target Populations Adults 65+, adults 18-64 at risk, children/adolescents at risk
Primary Outcomes Immune response (OPA, antibody levels), safety, vaccine effectiveness
Study Designs Randomized controlled trials, test-negative design effectiveness study
Comparators PPSV23, 13-valent PCV, no vaccination
Key Measures GMTs, seroconversion rates, adverse events, prevention of pneumococcal diseases
Special Considerations Co-administration with other vaccines, effects in specific risk groups

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the safety, immune response, and effectiveness of pneumococcal vaccines containing serotype 8, often as part of broader multi-valent vaccines, for preventing pneumococcal diseases in various populations.
  • Who are the target populations for these trials? The trials target various groups, including healthy adults, adults aged 65 and older, children and adolescents at increased risk of pneumococcal disease, and adults with specific medical conditions that increase their risk of pneumococcal infections.
  • What are some of the key outcomes being measured? Key outcomes include immune responses (measured by antibody levels and opsonophagocytic activity), safety profiles (adverse events), and vaccine effectiveness against pneumococcal diseases, particularly community-acquired pneumonia in some trials.
  • How do these trials compare new vaccines to existing ones? Several trials compare new vaccine formulations (like V116 or 20-valent pneumococcal conjugate vaccine) to existing vaccines such as PPSV23 or 13-valent pneumococcal conjugate vaccine, looking at immune responses, safety, and effectiveness.
  • What is unique about the pneumococcal serotype 8 in these vaccines? Pneumococcal serotype 8 is one of several serotypes included in these broader pneumococcal vaccines. It's part of efforts to expand coverage against different pneumococcal strains, potentially offering broader protection against pneumococcal diseases.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 8

  • 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 8: A specific type of pneumococcal bacteria covered by the vaccines being studied. It's one of several serotypes included to provide broad protection against pneumococcal diseases.
  • Opsonophagocytic activity (OPA): A measure of the immune system's ability to kill bacteria. In these trials, it's used to assess how well the vaccines stimulate the immune response against pneumococcal bacteria.
  • Geometric mean titers (GMTs): A way to measure the average concentration of antibodies in the blood, used to evaluate the strength of the immune response to vaccines.
  • Community-acquired pneumonia (CAP): Pneumonia that develops outside of hospitals or healthcare facilities. Some trials are specifically looking at how well the vaccines prevent this type of pneumonia.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a strong antigen to improve the immune response. In these trials, pneumococcal polysaccharides are often conjugated to a carrier protein.
  • Serotype: A distinct variation within a species of bacteria or virus. In this context, it refers to different types of pneumococcal bacteria targeted by the vaccines.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Vaccine effectiveness (VE): A measure of how well a vaccine prevents disease in real-world conditions, often expressed as a percentage.
  • CRM197: A non-toxic mutant of diphtheria toxin commonly used as a carrier protein in conjugate vaccines to enhance the immune response.

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/2023-506236-32-00
  7. http://clinicaltrials.eu/trial-id/2023-507293-40-00