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Abc-23A-116

Clinical trials are underway to assess the safety, tolerability, and immunogenicity of V116, a new 21-valent pneumococcal conjugate vaccine. These studies aim to evaluate V116 in various populations at increased risk for pneumococcal disease, including adults, children, and adolescents. The trials compare V116 to existing pneumococcal vaccines and measure immune responses and adverse events following vaccination.

Table of Contents

What is ABC-23A-116?

ABC-23A-116 is a new vaccine being developed to protect against pneumococcal disease. It is part of a larger vaccine called V116, which is a 21-valent pneumococcal conjugate vaccine. This means it targets 21 different types (serotypes) of pneumococcal bacteria[1]. ABC-23A-116 specifically refers to one of the components in this vaccine that targets the 23A serotype of pneumococcus.

Purpose of ABC-23A-116

The main purpose of ABC-23A-116, as part of the V116 vaccine, is to prevent pneumococcal infections. These infections can cause serious diseases like pneumonia, meningitis, and bloodstream infections. The vaccine is being developed to protect people who are at increased risk of pneumococcal disease, including adults, children, and adolescents with certain medical conditions[2][3].

How ABC-23A-116 Works

ABC-23A-116 works by stimulating the body’s immune system to produce antibodies against the 23A serotype of pneumococcal bacteria. It is a conjugate vaccine, which means the bacterial sugar (polysaccharide) is attached to a carrier protein called CRM197. This combination helps to create a stronger and longer-lasting immune response, especially in young children[1].

Ongoing Clinical Trials

Several clinical trials are currently being conducted to evaluate the safety and effectiveness of the V116 vaccine, which includes ABC-23A-116. These trials are focusing on different groups of people:

  • Adults aged 18 to 64 years who are at increased risk of pneumococcal disease[1]
  • Adults aged 50 years and older[2]
  • Children and adolescents with increased risk of pneumococcal disease[3]

These trials are measuring how well the vaccine stimulates the immune system and monitoring for any side effects. They are comparing V116 to existing pneumococcal vaccines to see if it provides better protection[1][2][3].

Who Can Receive ABC-23A-116?

The V116 vaccine, which includes ABC-23A-116, is being studied in people who are at higher risk for pneumococcal disease. This includes:

  • Adults with certain medical conditions such as diabetes, chronic liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease[1]
  • Adults aged 50 years and older[2]
  • Children and adolescents with increased risk of pneumococcal disease due to medical conditions like diabetes, chronic liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease[3]

It’s important to note that the vaccine is still in clinical trials and is not yet available for general use.

Potential Benefits and Risks

The potential benefits of ABC-23A-116, as part of the V116 vaccine, include protection against pneumococcal infections caused by the 23A serotype. This could help prevent serious illnesses like pneumonia, meningitis, and bloodstream infections in people at high risk[1][2][3].

As with any vaccine, there may be some risks or side effects. The clinical trials are carefully monitoring for any adverse events. Common side effects of vaccines can include pain at the injection site, fatigue, headache, and muscle pain. More serious side effects are rare but are being closely watched for in the trials[1][2][3].

Conclusion

ABC-23A-116 is a promising component of the new V116 pneumococcal vaccine. While it’s still in the testing phase, it has the potential to provide improved protection against pneumococcal disease for people at high risk. As research continues, we’ll learn more about its effectiveness and safety profile. If you’re interested in learning more about this vaccine or think you might be eligible for a clinical trial, it’s best to speak with your healthcare provider.

Aspect Details
Vaccine V116 (21-valent pneumococcal conjugate vaccine)
Study Populations Adults 18-64 with risk factors, adults 50+, children/adolescents at risk
Primary Objectives Evaluate safety, tolerability, and immunogenicity
Comparator Vaccines PPSV23, PCV15
Key Measurements OPA antibody levels, IgG concentrations, adverse events
Administration 0.5 mL intramuscular injection
Follow-up Period 30 days post-vaccination for primary endpoints

FAQ

  • What is V116? V116 is a new 21-valent pneumococcal conjugate vaccine being studied for the prevention of pneumococcal disease in various at-risk populations.
  • Who is being included in these clinical trials? The trials are including adults aged 18-64 with risk factors, adults 50 years and older, and children/adolescents at increased risk of pneumococcal disease.
  • What are the main goals of these studies? The main goals are to evaluate the safety, tolerability, and immune responses produced by V116 compared to existing pneumococcal vaccines.
  • How is the vaccine's effectiveness being measured? Effectiveness is being measured through blood tests that look at antibody levels and the ability of antibodies to kill pneumococcal bacteria in lab tests.
  • What side effects are being monitored? The studies are monitoring for injection site reactions, systemic side effects like fever, and any serious adverse events that may be related to the vaccine.

Ongoing Clinical Trials on Abc-23A-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, meningitis, and bloodstream infections.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to improve the immune response.
  • Opsonophagocytic activity (OPA): A laboratory test that measures the ability of antibodies to help immune cells engulf and kill 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 out antibody levels across a group of people in vaccine studies.
  • Adverse event (AE): Any unfavorable medical occurrence in a clinical trial participant, whether or not it is caused by the study treatment.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • PPSV23: The 23-valent pneumococcal polysaccharide vaccine, an existing vaccine that protects against 23 types of pneumococcal bacteria.

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/