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Pneumococcal Polysaccharide Serotype 9N Conjugated To Crm197

Clinical trials are currently underway to assess the safety, tolerability, and immunogenicity of V116, a new 21-valent pneumococcal conjugate vaccine. These studies aim to evaluate the vaccine’s potential in preventing pneumococcal disease in various populations, including adults at increased risk, older adults, and children and adolescents with higher risk factors. The trials compare V116 to existing pneumococcal vaccines and measure immune responses and adverse events to determine its effectiveness and safety profile.

Table of Contents

What is Pneumococcal Disease?

Pneumococcal disease is a serious infection caused by bacteria called Streptococcus pneumoniae, also known as pneumococcus. This disease can lead to various health problems, including pneumonia (lung infection), meningitis (infection of the covering of the brain and spinal cord), and bloodstream infections. It’s particularly dangerous for young children, older adults, and people with certain medical conditions.[1]

Understanding the Vaccine Component

The PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N CONJUGATED TO CRM197 is a specific component of a new vaccine called V116. This vaccine is designed to protect against pneumococcal disease. The “9N” refers to a specific type (serotype) of pneumococcus that the vaccine targets. “CRM197” is a carrier protein that helps boost the immune response to the vaccine.[1]

Clinical Trials and Research

Several clinical trials are currently underway to evaluate the safety and effectiveness of V116, which includes the PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N CONJUGATED TO CRM197 component. These studies are being conducted in different age groups and populations:

  • Adults aged 18 to 64 years with increased risk for pneumococcal disease[1]
  • Adults 50 years of age or older[2]
  • Children and adolescents with increased risk of pneumococcal disease[3]

These trials aim to assess how well the vaccine stimulates the immune system and its safety profile in different groups of people.

Who Can Benefit from This Vaccine?

Based on the ongoing clinical trials, the V116 vaccine, which includes the PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N CONJUGATED TO CRM197 component, may potentially benefit:

  • Adults with increased risk for pneumococcal disease due to conditions such as:
    • Diabetes mellitus
    • Chronic liver disease
    • Chronic obstructive pulmonary disease (COPD)
    • Asthma
    • Chronic heart disease
    • Chronic kidney disease[1]
  • Adults aged 50 years or older[2]
  • Children and adolescents with increased risk of pneumococcal disease due to similar conditions as adults[3]

Safety and Effectiveness

The clinical trials are designed to evaluate both the safety and effectiveness of the V116 vaccine. Researchers are looking at:

  • The proportion of participants who experience adverse events (side effects)[1][2][3]
  • The immune response to the vaccine, measured by:
    • Opsonophagocytic activity (OPA): This measures how well antibodies produced by the vaccine can help immune cells engulf and destroy pneumococcal bacteria
    • Immunoglobulin G (IgG) levels: These are antibodies produced by the immune system in response to the vaccine[1][2][3]

Administration and Dosage

The V116 vaccine, which includes the PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N CONJUGATED TO CRM197 component, is administered as an intramuscular injection. The typical dose is 0.5 ml.[1][2][3]

Potential Side Effects

As with any vaccine, there may be potential side effects. The clinical trials are carefully monitoring for both local reactions at the injection site and systemic reactions. Common side effects of vaccines may include:

  • Pain, redness, or swelling at the injection site
  • Fatigue
  • Headache
  • Muscle pain
  • Fever[1][2][3]

It’s important to note that the occurrence and severity of side effects can vary from person to person. The ongoing clinical trials will provide more detailed information about the safety profile of this vaccine.

Aspect Details
Vaccine Name V116 (Pneumococcal 21-valent Conjugate Vaccine)
Study Phases Phase 3
Study Populations Adults 18-64 at increased risk, Adults 50+, Children and adolescents at higher risk
Primary Objectives Safety, tolerability, immunogenicity
Comparator Vaccines PPSV23, PCV15
Key Immune Measurements OPA GMTs, IgG GMCs, ≥4-fold rise in antibody levels
Safety Assessments Injection-site AEs, systemic AEs, vaccine-related SAEs
Administration Route Intramuscular injection
Dose 0.5 mL

FAQ

  • What is V116? V116 is a new 21-valent pneumococcal conjugate vaccine being studied for its potential to prevent pneumococcal disease in various populations.
  • Who is being included in these clinical trials? The trials include adults aged 18-64 at increased risk for pneumococcal disease, adults 50 years and older, and children and adolescents with higher risk factors for pneumococcal disease.
  • What are the main objectives of these clinical trials? The main objectives are to evaluate the safety, tolerability, and immunogenicity of V116 compared to existing pneumococcal vaccines, and to measure immune responses and adverse events following vaccination.
  • How is the immune response being measured in these trials? The immune response is being measured through serotype-specific opsonophagocytic activity (OPA) and immunoglobulin G (IgG) levels, as well as the proportion of participants showing a significant increase in these markers after vaccination.
  • What safety aspects are being monitored in these trials? The trials are monitoring for adverse events, including injection-site reactions, systemic reactions, and any serious adverse events that may be related to the vaccine.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 9N Conjugated To Crm197

  • Study of Pneumococcal Vaccine Response in Patients Without a Spleen: Comparing Vaccination Before and After Spleen Removal Using PCV20 and PCV21

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Immune Response of V116 Vaccine for Pneumococcal Disease in Adults Aged 50 and Older

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany Spain

  • Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Finland France Poland Spain Sweden

  • Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

    Not recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Pneumococcal disease: An infection caused by the bacterium Streptococcus pneumoniae, which can lead to various illnesses including pneumonia, meningitis, and bloodstream infections.
  • 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 measure of the ability of antibodies to help immune cells engulf and destroy bacteria, used to assess the effectiveness of pneumococcal vaccines.
  • Immunoglobulin G (IgG): The most common type of antibody in blood and other body fluids, playing a crucial role in the immune response against pathogens.
  • Geometric mean titers (GMTs): A way of measuring the average concentration of antibodies in a group of people, used to assess immune responses to vaccines.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of Streptococcus pneumoniae targeted by the vaccine.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance the immune response.
  • PPSV23: Pneumococcal Polysaccharide Vaccine, a 23-valent vaccine used to prevent pneumococcal infections in adults and older children.

References

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