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Abc-31-116

Recent clinical trials are investigating the safety, tolerability, and immunogenicity of V116, a new pneumococcal vaccine. These studies focus on different age groups, including adults with increased risk of pneumococcal disease, as well as children and adolescents. The trials aim to compare V116 with existing pneumococcal vaccines and assess its potential in preventing pneumococcal infections.

Table of Contents

What is ABC-31-116?

ABC-31-116 is a component of a new pneumococcal vaccine called V116 that is currently being studied in clinical trials. It is one of several pneumococcal polysaccharide serotypes that are combined to create the V116 vaccine[1]. Pneumococcal vaccines help protect against infections caused by the bacteria Streptococcus pneumoniae, which can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections.

Purpose of ABC-31-116

The purpose of including ABC-31-116 in the V116 vaccine is to provide protection against a specific strain or type of pneumococcal bacteria. By combining multiple serotypes like ABC-31-116, the vaccine aims to offer broader protection against various pneumococcal infections[2].

Clinical Trials Involving ABC-31-116

ABC-31-116 is being studied as part of the V116 vaccine in several clinical trials:

  • A study in adults aged 18-64 at increased risk of pneumococcal infection[1]
  • A study in adults 50 years of age or older[2]
  • A study in children and adolescents with increased risk of pneumococcal disease[3]

These trials are designed to evaluate the safety, tolerability, and immune response to the V116 vaccine, which includes ABC-31-116.

Potential Benefits

The inclusion of ABC-31-116 in the V116 vaccine may offer several potential benefits:

  • Increased protection against pneumococcal infections
  • Broader coverage of pneumococcal strains compared to existing vaccines
  • Potentially improved immune response in people at higher risk of pneumococcal disease

However, it’s important to note that these benefits are still being studied and have not yet been proven in large-scale clinical trials[1][2][3].

Safety Considerations

The clinical trials are carefully monitoring the safety of the V116 vaccine, including the ABC-31-116 component. Researchers are looking at:

  • Injection site reactions (such as pain, redness, or swelling)
  • Systemic reactions (such as fever, fatigue, or headache)
  • Any serious side effects that may occur

As with any vaccine, there may be potential risks and side effects. The ongoing trials will help determine the safety profile of ABC-31-116 as part of the V116 vaccine[1][2][3].

Who May Benefit from ABC-31-116?

Based on the current clinical trials, ABC-31-116 (as part of the V116 vaccine) may potentially benefit:

  • Adults aged 18-64 with increased risk of pneumococcal infection, such as those with:
    • Diabetes
    • Chronic liver disease
    • Chronic obstructive pulmonary disease (COPD)
    • Asthma
    • Chronic heart disease
    • Chronic kidney disease
  • Adults 50 years of age or older
  • Children and adolescents with increased risk of pneumococcal disease

However, the specific groups that may benefit most from this vaccine component will be determined based on the results of the clinical trials[1][2][3].

Future Outlook

The development of ABC-31-116 as part of the V116 vaccine represents ongoing efforts to improve protection against pneumococcal infections. If the clinical trials show positive results in terms of safety and effectiveness, this new vaccine component could potentially offer better protection for people at risk of pneumococcal disease.

It’s important to note that ABC-31-116 is still in the research phase, and more studies are needed to fully understand its benefits and potential risks. Patients should consult with their healthcare providers for the most up-to-date information on pneumococcal vaccines and which options may be best for their individual circumstances[1][2][3].

Aspect Details
Vaccine Name V116 (Pneumococcal 21-valent Conjugate Vaccine)
Study Phases Phase 3 clinical trials
Study Populations Adults 18-64 with increased risk, Adults 50+, Children and adolescents with increased risk
Primary Objectives Evaluate safety, tolerability, and immunogenicity of V116
Comparison V116 vs. PPSV23 (existing pneumococcal vaccine)
Key Measurements Adverse events, OPA GMTs, IgG GMCs, GMFRs
Administration 0.5 ml intramuscular injection
Risk Conditions Diabetes, chronic liver/lung/heart/kidney disease

FAQ

  • What is V116? V116 is a new pneumococcal vaccine being studied in clinical trials. It is designed to protect against various strains of pneumococcal bacteria that can cause serious infections.
  • Who is being included in these clinical trials? The trials include different groups: adults aged 18-64 with increased risk of pneumococcal disease, adults 50 years and older, and children and adolescents with increased risk of pneumococcal disease.
  • What are the main objectives of these trials? The main objectives are to evaluate the safety and tolerability of V116, and to compare its ability to produce an immune response (immunogenicity) with existing pneumococcal vaccines.
  • How is the vaccine administered? V116 is administered as an intramuscular injection, typically as a single 0.5 ml dose.
  • 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 (such as COPD or asthma), chronic heart disease, and chronic kidney disease.

Ongoing Clinical Trials on Abc-31-116

  • 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.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Opsonophagocytic activity (OPA): A measure of the body's ability to identify and destroy bacteria with the help of antibodies and immune cells.
  • Geometric mean titers (GMTs): A way to measure the average concentration of antibodies in a group of people after vaccination.
  • Adverse events (AEs): Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, which may or may not be related to the treatment being studied.
  • Serotype: A distinct variation within a species of bacteria, identified by the immune system.
  • Immunoglobulin G (IgG): A type of antibody that plays a crucial role in the body's immune response against pathogens.
  • Geometric mean fold rise (GMFR): The average increase in antibody levels after vaccination, compared to levels before vaccination.
  • PPSV23: Pneumococcal polysaccharide vaccine, a 23-valent vaccine used to prevent pneumococcal infections in adults.
  • Invasive pneumococcal disease (IPD): A severe infection where pneumococcal bacteria enter normally sterile sites in the body, such as the blood or spinal 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/