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Pneumococcal Polysaccharide Serotype 17F Conjugated To Crm197

This article discusses clinical trials investigating the V116 pneumococcal vaccine, which contains pneumococcal polysaccharide serotype 17F conjugated to CRM197 among other serotypes. The trials aim to evaluate the safety, tolerability, and immune responses of V116 in different populations at increased risk for pneumococcal disease, including adults, children, and adolescents.

Table of Contents

What is V116?

V116 is a new vaccine being developed to prevent pneumococcal disease, which is an infection caused by the bacteria Streptococcus pneumoniae. This vaccine is known as a 21-valent conjugate vaccine, which means it targets 21 different types (serotypes) of pneumococcal bacteria[1]. The vaccine is designed to protect against some of the most common and dangerous strains of pneumococcal bacteria that can cause serious illnesses.

How Does V116 Work?

V116 works by stimulating the body’s immune system to produce antibodies against specific parts of the pneumococcal bacteria. It contains small pieces of 21 different pneumococcal serotypes, each attached (or “conjugated”) to a carrier protein called CRM197. This combination helps the immune system recognize and remember these bacterial components, allowing it to respond quickly if exposed to the actual bacteria in the future[2].

The vaccine is given as an intramuscular injection, typically in a single 0.5 ml dose[3]. This method of administration helps ensure that the vaccine components are properly delivered to the immune system.

Who is V116 For?

V116 is being studied for use in 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 infection[1]
  • Adults aged 50 years and older[2]
  • Children and adolescents with increased risk of pneumococcal disease[3]

Some of the medical conditions that may increase a person’s risk for pneumococcal disease include:

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

Clinical Trials and Research

V116 is currently being studied in several Phase 3 clinical trials. These trials are designed to evaluate the safety, tolerability, and effectiveness of the vaccine in different populations[1][2][3]. The main goals of these studies include:

  1. Assessing the safety of V116 by monitoring for adverse events after vaccination
  2. Measuring the immune response to V116 by looking at antibody levels and other immune markers
  3. Comparing V116 to existing pneumococcal vaccines to see if it provides similar or better protection

Researchers are particularly interested in how well V116 stimulates the production of antibodies against the pneumococcal serotypes it targets. They measure this using tests called opsonophagocytic activity (OPA) and Immunoglobulin G (IgG) levels[1][2][3].

Safety and Side Effects

As with any vaccine, safety is a top priority in the development of V116. The clinical trials are carefully monitoring for any side effects or adverse events. Some of the potential side effects being studied include:

  • Injection site reactions (such as pain, redness, or swelling at the injection site)
  • Systemic reactions (such as fever, fatigue, or headache)
  • Any serious adverse events that may be related to the vaccine

It’s important to note that experiencing some mild side effects after vaccination is normal and usually indicates that your immune system is responding to the vaccine[1][2][3].

Potential Benefits

If proven safe and effective, V116 could offer several potential benefits:

  • Protection against a wide range of pneumococcal serotypes, potentially reducing the risk of serious pneumococcal infections
  • Improved immune response in people who are at higher risk of pneumococcal disease
  • Possible reduction in the number of vaccine doses needed for protection compared to current vaccination schedules

However, it’s important to remember that V116 is still in the research phase. More data from the ongoing clinical trials will be needed to fully understand its effectiveness and safety profile[1][2][3].

Trial Aspect Details
Study Drug V116 (21-valent pneumococcal conjugate vaccine)
Target Populations Adults 18-64 at increased risk, Adults 50+, Children and adolescents at increased risk
Primary Objectives Evaluate safety, tolerability, and immunogenicity
Key Inclusion Criteria Specific risk conditions (e.g., diabetes, chronic liver/lung/heart/kidney disease)
Primary Endpoints Adverse events, OPA GMTs, IgG responses
Secondary Endpoints Serotype-specific immune responses, fold-rise in antibody levels
Study Design Randomized, double-blind, active comparator-controlled
Comparator PPSV23 (in some trials)

FAQ

  • What is the main purpose of the V116 vaccine clinical trials? The main purpose is to evaluate the safety, tolerability, and immunogenicity (immune response) of the V116 vaccine in different populations at increased risk for pneumococcal disease.
  • Who are the target populations for these clinical trials? The trials target adults aged 18-64 with increased risk factors, adults 50 years and older, and children and adolescents with increased risk of pneumococcal disease.
  • What are some of the risk factors for pneumococcal disease mentioned in the trials? Risk factors include diabetes mellitus, chronic liver disease, chronic lung disease (like COPD or asthma), chronic heart disease, and chronic kidney disease.
  • How is the immune response to the V116 vaccine measured? The immune response is measured through opsonophagocytic activity (OPA) and Immunoglobulin G (IgG) levels in the blood, comparing levels before and after vaccination.
  • What are the primary safety endpoints in these trials? The primary safety endpoints include the percentage of participants experiencing injection-site reactions, systemic adverse events, and vaccine-related serious adverse events.

Ongoing Clinical Trials on Pneumococcal Polysaccharide Serotype 17F Conjugated To Crm197

  • Study of Pneumococcal Vaccine Response in Patients Without a Spleen: Comparing Vaccination Before and After Spleen Removal Using PCV20 and PCV21

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • 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.
  • V116: A 21-valent pneumococcal conjugate vaccine being studied for prevention of pneumococcal disease.
  • Serotype: A distinct variation within a species of bacteria, in this case, different types of Streptococcus pneumoniae.
  • CRM197: A non-toxic mutant of diphtheria toxin used as a carrier protein in conjugate vaccines to enhance immune response.
  • Opsonophagocytic activity (OPA): A measure of antibody function, indicating 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 titers (GMTs): 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 temporarily associated with the use of a medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
  • PPSV23: Pneumococcal polysaccharide vaccine that contains 23 different serotypes 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/