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Abc-35B-116

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

Table of Contents

What is ABC-35B-116?

ABC-35B-116 is a new vaccine being developed to prevent pneumococcal infections. It is part of a larger vaccine called V116, which is a 21-valent pneumococcal conjugate vaccine[1]. This means it targets 21 different types (serotypes) of pneumococcal bacteria. ABC-35B-116 specifically refers to one of the components in this vaccine that targets the 35B serotype of pneumococcus[1].

What diseases does ABC-35B-116 target?

ABC-35B-116, as part of the V116 vaccine, is designed to prevent pneumococcal infections[1]. Pneumococcal infections are caused by bacteria called Streptococcus pneumoniae. These infections can range from mild to severe and include:

  • Pneumonia (infection of the lungs)
  • Meningitis (infection of the lining of the brain and spinal cord)
  • Bacteremia (infection of the blood)
  • Ear infections
  • Sinus infections

The most serious form is called invasive pneumococcal disease (IPD), which includes infections of the blood, lungs, and brain[1][2].

How does ABC-35B-116 work?

ABC-35B-116 works by stimulating the body’s immune system to produce antibodies against the 35B serotype of pneumococcal bacteria. It is a conjugate vaccine, which means the bacterial sugar (polysaccharide) is attached to a protein carrier called CRM197[1]. This combination helps to create a stronger immune response, especially in young children.

When a person receives the V116 vaccine containing ABC-35B-116, their immune system learns to recognize and fight off the 35B serotype of pneumococcus, along with the other 20 serotypes included in the vaccine[1].

Who is ABC-35B-116 intended for?

Based on the clinical trials information, ABC-35B-116 (as part of the V116 vaccine) is being studied in several groups:

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

People at increased risk for pneumococcal disease include those with certain medical conditions such as:

  • Diabetes mellitus
  • Chronic liver disease
  • Chronic obstructive pulmonary disease (COPD)
  • Asthma
  • Chronic heart disease
  • Chronic kidney disease[1]

Clinical trials of ABC-35B-116

ABC-35B-116, as part of the V116 vaccine, is currently being studied in Phase 3 clinical trials. These trials are designed to evaluate the safety, tolerability, and effectiveness of the vaccine in different populations. Some key aspects of these trials include:

  • Comparing V116 to existing pneumococcal vaccines like PPSV23 (pneumococcal polysaccharide vaccine)[2][3]
  • Measuring the immune response by looking at antibody levels and the ability of these antibodies to kill pneumococcal bacteria (opsonophagocytic activity or OPA)[1][2][3]
  • Assessing the safety of the vaccine by monitoring for side effects and adverse events[1][2][3]

Potential benefits and side effects

The potential benefits of ABC-35B-116 (as part of V116) include protection against pneumococcal infections caused by the 35B serotype and the other serotypes included in the vaccine. This could help prevent serious illnesses like pneumonia, meningitis, and bloodstream infections.

As with any vaccine, there may be side effects. The clinical trials are monitoring for:

  • Injection site reactions (pain, redness, swelling)
  • Systemic reactions (fever, fatigue, headache)
  • Any serious adverse events related to the vaccine[1][2][3]

It’s important to note that the full safety profile of ABC-35B-116 will be better understood once the clinical trials are completed.

Current status and future prospects

ABC-35B-116, as part of the V116 vaccine, is still in the research phase. The ongoing Phase 3 clinical trials will help determine its safety and effectiveness. If the results are positive, it could potentially become a new tool in preventing pneumococcal infections, especially for people at higher risk.

However, it’s important to remember that the vaccine is not yet approved for use outside of clinical trials. More research is needed before it can be made available to the public. The results of these studies will help health authorities decide if and when the vaccine should be approved for general use.

Aspect Details
Study Type Phase 3, randomized, double-blind clinical trials
Vaccine Studied V116 (Pneumococcal 21-valent Conjugate Vaccine)
Comparator PPSV23 (23-valent pneumococcal polysaccharide vaccine)
Study Populations Adults 18-64 at increased risk, adults 50+, children and adolescents at higher risk
Primary Objectives Safety, tolerability, immunogenicity
Key Measurements Adverse events, OPA GMTs, IgG GMCs, proportion with ≥4-fold antibody rise
Risk Conditions Diabetes, chronic liver/lung/heart/kidney disease
Administration Intramuscular injection, 0.5 mL dose
Follow-up Period 30 days post-vaccination for primary immunogenicity endpoints

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 higher risk factors for pneumococcal infections.
  • What are the main goals of these clinical trials? The main goals are to evaluate the safety and tolerability of V116, assess its ability to produce an immune response, and compare it to existing pneumococcal vaccines.
  • How is the immune response being measured? The immune response is being measured through blood tests that look at antibody levels (IgG) and the ability of antibodies to kill pneumococcal bacteria (opsonophagocytic activity or OPA).
  • What are some of the risk factors that make people eligible for these trials? Risk factors include conditions such as diabetes, chronic liver disease, chronic lung disease (like COPD or asthma), chronic heart disease, and chronic kidney disease.

Ongoing Clinical Trials on Abc-35B-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 serious illnesses like pneumonia, bloodstream infections, and meningitis.
  • Opsonophagocytic activity (OPA): A measure of how well antibodies can help immune cells engulf and destroy bacteria, used to assess vaccine effectiveness.
  • Immunoglobulin G (IgG): A type of antibody produced by the immune system in response to infections or vaccines.
  • Geometric mean titers (GMTs): A way to average out antibody levels in a group of people, used to compare immune responses.
  • Adverse events (AEs): Any unfavorable or unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it's related to the treatment being studied.
  • Serotype: A distinct variation within a species of bacteria, in this case, different strains of pneumococcal bacteria.
  • PPSV23: Pneumococcal polysaccharide vaccine that protects against 23 types of pneumococcal bacteria, typically given to older adults or those with certain health conditions.
  • Conjugate vaccine: A type of vaccine that joins a weak antigen to a strong antigen to create a more powerful immune response.
  • CRM197: A non-toxic form of diphtheria toxin used in some vaccines to help boost the immune response.
  • Invasive pneumococcal disease (IPD): A severe infection where pneumococcal bacteria enter normally sterile sites in the body, such as the bloodstream 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/