Pneumococcal Polysaccharide Serotype 12F

This article summarizes several clinical trials investigating the use of pneumococcal vaccines containing the serotype 12F polysaccharide conjugated to CRM197 protein. These trials are evaluating the safety, immunogenicity, and effectiveness of new pneumococcal conjugate vaccines in various populations, including healthy adults, children, and those at increased risk of pneumococcal disease. The studies aim to assess immune responses, compare different vaccine formulations, and determine real-world effectiveness against pneumococcal infections.

Table of Contents

What is the pneumococcal polysaccharide serotype 12F vaccine?

The pneumococcal polysaccharide serotype 12F vaccine is a component of broader pneumococcal vaccines designed to protect against infections caused by the Streptococcus pneumoniae bacteria, specifically the 12F serotype. This vaccine is typically included as part of larger pneumococcal conjugate vaccines that protect against multiple serotypes.[1]

Pneumococcal vaccines containing the 12F serotype are used to prevent serious pneumococcal diseases such as pneumonia, meningitis, and bloodstream infections. The 12F serotype is one of many pneumococcal strains that these vaccines target.

How does it work?

The vaccine works by stimulating the immune system to produce antibodies against the specific pneumococcal serotype 12F. It contains a small amount of the outer coating (polysaccharide) of the 12F pneumococcal bacteria, which is chemically linked (conjugated) to a protein carrier called CRM197.[2]

This conjugation process enhances the immune response, especially in young children and older adults. When vaccinated, your body recognizes the 12F polysaccharide as foreign and produces antibodies against it. If you’re later exposed to the actual 12F pneumococcal bacteria, your immune system is primed to recognize and fight off the infection more effectively.

Who needs this vaccine?

Pneumococcal vaccines containing the 12F serotype are recommended for several groups:

  • Adults aged 65 and older
  • Children under 2 years old
  • 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
  • Smokers
  • Individuals with asthma

Your healthcare provider can advise if you or your child should receive a pneumococcal vaccine containing the 12F serotype based on age, health status, and previous vaccination history.[3]

How effective is it?

The effectiveness of pneumococcal vaccines containing the 12F serotype has been demonstrated in various clinical studies. These vaccines have shown to be highly effective in preventing invasive pneumococcal disease caused by the included serotypes, including 12F.

For example, one study found that a 20-valent pneumococcal conjugate vaccine (which includes serotype 12F) was effective in inducing robust immune responses in adults aged 18 and older.[4] The vaccine effectiveness can vary depending on factors such as age, overall health, and specific pneumococcal serotypes, but generally provides significant protection against severe pneumococcal infections.

Is it safe?

Pneumococcal vaccines containing the 12F serotype have been extensively studied and are considered safe for use. They have undergone rigorous clinical trials and continue to be monitored for safety after approval.

Like all vaccines, pneumococcal vaccines can cause side effects, but serious reactions are rare. The benefits of protection against potentially life-threatening pneumococcal infections generally outweigh the risks of vaccination for recommended groups.[5]

How is it given?

The pneumococcal vaccine containing serotype 12F is typically administered as an intramuscular injection, usually in the upper arm for adults or the thigh for young children. The number of doses and schedule can vary depending on the specific vaccine and the person’s age and health status.

For adults 65 and older, a single dose is often recommended. For children, the vaccine is usually given as a series of doses starting in infancy. Your healthcare provider will determine the appropriate vaccination schedule based on current guidelines and your individual circumstances.[2]

What are the potential side effects?

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

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

Serious allergic reactions are very rare but can occur. If you experience symptoms such as difficulty breathing, rapid heartbeat, or severe dizziness after vaccination, seek immediate medical attention.[5]

Ongoing research

Research on pneumococcal vaccines, including those containing the 12F serotype, is ongoing. Scientists are continually working to improve vaccine effectiveness, broaden coverage against more serotypes, and optimize vaccination strategies.

Recent studies have been investigating the use of higher-valent pneumococcal conjugate vaccines that protect against more serotypes, including 12F. For instance, a Phase 3 clinical trial is evaluating the safety and effectiveness of a new 20-valent pneumococcal conjugate vaccine (which includes serotype 12F) in adults aged 65 and older.[4]

Additionally, researchers are studying the long-term effectiveness of these vaccines and their impact on pneumococcal disease rates in different populations. This ongoing research helps inform vaccination recommendations and strategies to better protect people from pneumococcal infections.

Trial Aspect Details
Vaccine Types 20-valent pneumococcal conjugate vaccine (20vPnC), 21-valent pneumococcal conjugate vaccine (V116)
Study Populations Healthy adults 18-65+, children/adolescents at risk, adults with specific health conditions
Key Objectives Assess safety, immunogenicity, effectiveness against pneumococcal disease
Primary Endpoints Antibody responses (OPA, IgG), adverse events, vaccine effectiveness
Study Designs Randomized controlled trials, test-negative design effectiveness study
Comparators 13-valent pneumococcal conjugate vaccine (PCV13), 23-valent pneumococcal polysaccharide vaccine (PPSV23)
Follow-up Duration 30 days to 6 months post-vaccination

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 12F

  • 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

  • Pneumococcal polysaccharide: A sugar molecule found on the surface of pneumococcal bacteria that helps trigger an immune response when used in a vaccine.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcal bacteria.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response.
  • Conjugate vaccine: A type of vaccine where a weak antigen is attached to a stronger antigen to improve the immune response.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies help immune cells engulf and destroy bacteria.
  • IgG: Immunoglobulin G, the most common type of antibody found in blood and other bodily fluids.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Vaccine effectiveness: A measure of how well a vaccine prevents disease in real-world conditions outside of clinical trials.
  • Invasive pneumococcal disease: A severe infection caused by pneumococcal bacteria entering normally sterile sites like the bloodstream or spinal fluid.
  • Community-acquired pneumonia (CAP): Pneumonia that is acquired outside of a healthcare setting, often caused by pneumococcal bacteria.

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/study-on-the-v116-vaccine-for-adults-aged-18-64-at-increased-risk-of-pneumococcal-infection/
  4. http://clinicaltrials.eu/trial-id/2022-503144-40-00
  5. http://clinicaltrials.eu/trial/study-on-the-safety-and-immune-response-of-v116-vaccine-in-children-and-adolescents-at-higher-risk-for-pneumococcal-disease/