Abc-15A-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 different age groups and populations at increased risk for pneumococcal disease. The trials compare V116 to existing pneumococcal vaccines and measure immune responses and adverse events following vaccination.

Table of Contents

What is V116?

V116 is a new pneumococcal vaccine being developed to protect against pneumococcal disease. Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae, also known as pneumococcus. These bacteria can cause various illnesses, ranging from mild to severe, including pneumonia, ear infections, sinus infections, and more serious invasive diseases like meningitis and bloodstream infections[1].

This vaccine is known as a 21-valent conjugate vaccine, which means it targets 21 different types (serotypes) of pneumococcal bacteria. The term “conjugate” refers to the way the vaccine is made, linking (or conjugating) parts of the bacteria to a carrier protein to enhance the immune response[2].

Who is V116 for?

V116 is being developed for several groups of people who are at increased risk of pneumococcal disease:

  • 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]

The medical conditions that may increase the risk of pneumococcal disease include:

  • Diabetes mellitus (treated with medication)
  • Chronic liver disease
  • Chronic lung diseases like COPD (Chronic Obstructive Pulmonary Disease) or asthma
  • Chronic heart disease
  • Chronic kidney disease

How V116 Works

V116 works by stimulating the body’s immune system to produce antibodies against 21 different types of pneumococcal bacteria. These antibodies help the body recognize and fight off these bacteria if you’re exposed to them in the future[1][2][3].

The vaccine contains small parts of the pneumococcal bacteria, called polysaccharides, which are linked (conjugated) to a carrier protein called CRM197. This conjugation helps to create a stronger and longer-lasting immune response, especially in young children[3].

Clinical Trials

V116 is currently being studied in several Phase 3 clinical trials. These are large-scale studies designed to confirm the safety and effectiveness of the vaccine before it can be approved for general use. The trials are focusing on different groups:

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

In these trials, researchers are looking at how well V116 stimulates the immune system to produce antibodies against pneumococcal bacteria. They’re measuring this by looking at the levels of antibodies in the blood and how well these antibodies can kill pneumococcal bacteria in laboratory tests[1][2][3].

Safety and Side Effects

A key part of these clinical trials is to assess the safety of V116. Researchers are carefully monitoring for any side effects or adverse events that occur after vaccination. Some of the things they’re specifically looking at include:

  • Injection site reactions (like pain, redness, or swelling where the vaccine was given)
  • Systemic reactions (like fever, fatigue, or headache)
  • Any serious adverse events that might be related to the vaccine[1][2][3]

It’s important to note that while these potential side effects are being studied, they are common with many vaccines and usually mild and short-lived. The benefits of protection against pneumococcal disease typically far outweigh the risks of vaccination[1][2][3].

Conclusion

V116 is a promising new pneumococcal vaccine that could offer protection against a wide range of pneumococcal bacteria. It’s being developed for both adults and children who are at increased risk of pneumococcal disease. While it’s still in the clinical trial phase, the results of these studies will help determine if V116 is safe and effective for use in the general population. If successful, it could become an important tool in preventing pneumococcal disease and its complications[1][2][3].

Aspect Details
Vaccine V116 (21-valent pneumococcal conjugate vaccine)
Study Populations Adults 18-64 at increased risk, adults 50+, children/adolescents with risk factors
Comparator PPSV23 (23-valent pneumococcal polysaccharide vaccine)
Primary Outcomes Safety (adverse events), Immunogenicity (OPA and IgG levels)
Secondary Outcomes Geometric mean fold rise, proportion with 4-fold antibody increase
Risk Conditions Diabetes, liver disease, lung disease, heart disease, kidney disease
Administration Intramuscular injection, 0.5 mL dose
Follow-up Period Primary measurements at 30 days post-vaccination

Ongoing Clinical Trials on Abc-15A-116

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

    Not recruiting

    3 1 1 1
    Germany Spain
  • Study on the Safety and Immune Response of V116 Vaccine in Children and Adolescents at Higher Risk for Pneumococcal Disease

    Not recruiting

    3 1 1 1
    Finland France Poland Spain Sweden
  • Study on the V116 Vaccine for Adults Aged 18-64 at Increased Risk of Pneumococcal Infection

    Not recruiting

    3 1 1
    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 where bacterial sugars are attached to a protein carrier, enhancing the immune response, especially in young children.
  • Serotype: A distinct variation within a species of bacteria, in this case referring to different strains of pneumococcus with unique surface structures.
  • Opsonophagocytic activity (OPA): A laboratory test that measures the ability of antibodies to help immune cells engulf and kill bacteria, used to assess vaccine-induced immunity.
  • Immunoglobulin G (IgG): A type of antibody produced by the immune system in response to infection or vaccination.
  • Geometric mean titer (GMT): A way of averaging antibody levels across a group of people, useful for comparing immune responses.
  • Adverse event (AE): Any unfavorable medical occurrence in a clinical trial participant, whether or not considered related to the vaccine.
  • PPSV23: 23-valent pneumococcal polysaccharide vaccine, an existing vaccine that protects against 23 types of pneumococcal bacteria.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Geometric mean fold rise (GMFR): The average increase in antibody levels after vaccination, compared to pre-vaccination levels.

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/