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Abc-24F-116

Recent clinical trials are investigating the safety, tolerability, and immunogenicity of V116, a new 21-valent pneumococcal conjugate vaccine. These studies aim to assess the vaccine’s potential in preventing pneumococcal disease in various age groups and populations at increased risk. The trials compare V116 to existing pneumococcal vaccines and evaluate immune responses and adverse events following vaccination.

Table of Contents

What is ABC-24F-116?

ABC-24F-116 is a component of a new pneumococcal vaccine called V116 that is currently being studied in clinical trials[1]. This vaccine is being developed to protect against pneumococcal disease, which is an infection caused by bacteria called Streptococcus pneumoniae. These bacteria can cause various illnesses, ranging from mild infections like ear infections to severe and life-threatening conditions such as pneumonia, meningitis, and bloodstream infections[2].

Purpose of ABC-24F-116

The main purpose of ABC-24F-116, as part of the V116 vaccine, is to help prevent pneumococcal infections in different groups of people who are at increased risk. These groups include:

  • Adults aged 18 to 64 years with certain medical conditions that increase their risk of pneumococcal disease[1]
  • Adults aged 50 years and older[2]
  • Children and adolescents with increased risk of pneumococcal disease[3]

How ABC-24F-116 Works

ABC-24F-116 is a pneumococcal polysaccharide that is conjugated (attached) to a protein called CRM197[1]. This combination helps stimulate the immune system to produce antibodies against a specific type (serotype) of pneumococcal bacteria. By including ABC-24F-116 and other similar components in the V116 vaccine, researchers aim to provide protection against multiple serotypes of pneumococcal bacteria that commonly cause infections.

Ongoing Clinical Trials

ABC-24F-116, as part of the V116 vaccine, is currently being studied in several clinical trials:

  1. A study in adults aged 18 to 64 years with increased risk for pneumococcal disease[1]
  2. A study in adults aged 50 years and older[2]
  3. A study in children and adolescents with increased risk for pneumococcal disease[3]

These trials aim to evaluate the safety, tolerability, and immune response (immunogenicity) of the V116 vaccine in different populations.

Potential Benefits

If the clinical trials are successful, the V116 vaccine containing ABC-24F-116 could offer several potential benefits:

  • Protection against multiple types of pneumococcal bacteria, potentially reducing the risk of various pneumococcal infections[1][2][3]
  • Improved immune response in people who are at higher risk of pneumococcal disease due to age or underlying medical conditions[1][2][3]
  • Possible reduction in the need for multiple pneumococcal vaccines, as V116 is designed to target multiple serotypes[1][2][3]

Safety Considerations

As with any vaccine in clinical trials, researchers are carefully monitoring the safety of V116, including the ABC-24F-116 component. The ongoing studies are evaluating:

  • The occurrence of injection-site reactions, such as pain or swelling at the vaccination site[1][2][3]
  • Systemic reactions, which are effects that occur throughout the body, such as fever or fatigue[1][2][3]
  • Any serious adverse events that may be related to the vaccine[1][2][3]

It’s important to note that the vaccine is still in the testing phase, and its safety profile will be thoroughly evaluated before it can be considered for approval and widespread use.

Conclusion

ABC-24F-116 is a promising component of the V116 pneumococcal vaccine currently under investigation. As part of ongoing clinical trials, researchers are studying its potential to protect various groups of people against pneumococcal infections. While the results of these studies are not yet available, the development of this vaccine represents an important step in the ongoing efforts to prevent pneumococcal disease and its complications.

Aspect Details
Vaccine Name V116 (Pneumococcal 21-valent Conjugate Vaccine)
Study Phase Phase 3
Study Design Randomized, Double-blind, Active Comparator-controlled
Study Populations Adults 18-64 at increased risk, Adults 50+, Children and adolescents at increased risk
Primary Objectives Safety, tolerability, immunogenicity compared to existing vaccines
Key Measurements Adverse events, OPA GMTs, IgG GMCs, Proportion with ≥4-fold rise in antibodies
Administration 0.5 ml intramuscular injection
Risk Conditions Diabetes, chronic liver/lung/heart/kidney disease

FAQ

  • What is V116? V116 is a new 21-valent pneumococcal conjugate vaccine being studied for its potential to prevent pneumococcal disease in various age groups and at-risk populations.
  • Who is being included in these clinical trials? The trials include adults aged 18-64 with increased risk for pneumococcal disease, adults 50 years and older, and children and adolescents with increased risk of pneumococcal disease.
  • What are the main objectives of these studies? The main objectives are to evaluate the safety and tolerability of V116, as well as to compare its immune responses (measured by opsonophagocytic activity and antibody levels) to existing pneumococcal vaccines.
  • How is the vaccine administered? V116 is administered as an intramuscular injection, with a dose of 0.5 ml.
  • What are some of the conditions that put people at increased risk for pneumococcal disease? Some conditions that increase risk include diabetes mellitus, chronic liver disease, chronic lung disease (like COPD or asthma), chronic heart disease, and chronic kidney disease.

Ongoing Clinical Trials on Abc-24F-116

  • 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: Infections caused by Streptococcus pneumoniae bacteria, which can lead to pneumonia, bloodstream infections, or meningitis.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to enhance the immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function that indicates how well antibodies help immune cells engulf and destroy bacteria.
  • Immunoglobulin G (IgG): The most common type of antibody in blood that helps protect against bacterial and viral infections.
  • Geometric mean titer (GMT): A way to average the amount of antibodies in a group of people, useful for comparing immune responses.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs after receiving a vaccine, which may or may not be related to the vaccine.
  • Serotype: A distinct variation within a species of bacteria, in this case, different types of Streptococcus pneumoniae.
  • PPSV23: Pneumococcal polysaccharide vaccine, a 23-valent vaccine used to prevent pneumococcal infections in adults.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance immune response.
  • Invasive pneumococcal disease (IPD): A severe infection where pneumococcal bacteria enter normally sterile sites like blood or cerebrospinal fluid.

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/