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Ecoo75

This article discusses clinical trials investigating the use of ExPEC9V, a vaccine containing the active substance ECOO75 (among others), for preventing invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease in older adults. The trials aim to assess the vaccine’s efficacy, safety, and immune response in individuals aged 60 and above, particularly those with a history of urinary tract infections.

Table of Contents

What is ECOO75?

ECOO75 is one of the active components in a new vaccine called ExPEC9V (also known as JNJ-78901563) being developed to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease[1]. ExPEC refers to E. coli bacteria that can cause infections outside the intestines, such as urinary tract infections (UTIs) and more severe invasive infections.

Purpose of ECOO75

ECOO75 is designed to target a specific strain of E. coli (serotype O75) that can cause serious infections. It is part of a vaccine that aims to prevent:

  • Invasive ExPEC disease (IED): This includes infections in the blood or other normally sterile body sites[2]
  • Urinary tract infections (UTIs): Including more severe forms like pyelonephritis (kidney infection)[2]
  • Urosepsis: A life-threatening condition where a UTI leads to a bloodstream infection[2]

Target Population

The ExPEC9V vaccine, which includes ECOO75, is being studied in:

  • Adults aged 60 years and older[2]
  • People with a history of urinary tract infections in the past 2 years[2]
  • Individuals with additional risk factors for invasive E. coli disease, such as:
    • Previous urosepsis or E. coli bloodstream infection
    • Recent hospitalization
    • Conditions that increase the risk of complicated UTIs[2]

Clinical Trials

ECOO75, as part of the ExPEC9V vaccine, is currently being studied in Phase 3 clinical trials. These studies aim to:

  • Evaluate the vaccine’s effectiveness in preventing invasive E. coli infections and UTIs[2]
  • Assess the immune response produced by the vaccine[1]
  • Determine the safety and side effects of the vaccine[1][2]
  • Investigate how the vaccine affects quality of life and health status[2]

Potential Benefits

If successful, the ExPEC9V vaccine containing ECOO75 could potentially:

  • Reduce the incidence of serious E. coli infections, especially in older adults
  • Decrease hospitalizations related to E. coli infections
  • Lower the risk of complications from UTIs, such as kidney infections and sepsis
  • Improve quality of life for individuals prone to recurrent UTIs
  • Help combat antibiotic resistance by preventing infections that would require antibiotic treatment[2]

Safety and Side Effects

As with any vaccine, safety is a crucial aspect being studied in the clinical trials. The researchers are monitoring:

  • Local reactions: Such as pain, redness, or swelling at the injection site
  • Systemic reactions: Including fever, fatigue, or muscle aches
  • Serious adverse events: Any severe or unexpected reactions[1][2]
It’s important to note that the full safety profile of the vaccine will only be known after the completion of the clinical trials.

Conclusion

ECOO75, as a component of the ExPEC9V vaccine, represents a promising approach to preventing serious E. coli infections, particularly in older adults and those with a history of UTIs. While the research is still ongoing, this vaccine could potentially have a significant impact on reducing the burden of these infections and improving the quality of life for many individuals. As with any medical treatment, it’s essential to consult with healthcare providers for personalized advice and to stay informed about the latest developments in this area of research.

Aspect Details
Vaccine Name ExPEC9V (JNJ-78901563)
Target Population Adults aged 60 years and older with a history of urinary tract infections
Main Objective Prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease
Administration Intramuscular injection
Key Outcomes Measured Efficacy in preventing IED events, antibody responses, safety, impact on quality of life
Study Design Randomized, double-blind, placebo-controlled, multicenter Phase 3 study
Active Substances ECOO1A, ECOO2, ECOO4, ECOO6A, ECOO15, ECOO16, ECOO18A, ECOO25B, ECOO75
Secondary Objectives Evaluate efficacy against various E. coli-related infections, assess immunogenicity and safety

FAQ

  • What is ExPEC9V? ExPEC9V is a vaccine being studied to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease. It contains multiple active substances, including ECOO75, targeting different strains of E. coli.
  • Who is the target population for these clinical trials? The trials are focusing on adults aged 60 years and older, particularly those with a history of urinary tract infections in the past two years.
  • What is the main goal of these clinical trials? The main goal is to evaluate the efficacy of ExPEC9V in preventing invasive E. coli disease, as well as assessing its safety, immunogenicity, and impact on quality of life in older adults.
  • How is the vaccine administered? The ExPEC9V vaccine is administered as an intramuscular injection.
  • What are some of the key outcomes being measured in these trials? Key outcomes include the number of participants experiencing invasive E. coli disease events, antibody responses to the vaccine, safety and reactogenicity, and impact on health-related quality of life.

Ongoing Clinical Trials on Ecoo75

  • Study on the Safety and Immune Response of JNJ-78901563 and High-dose Influenza Vaccine in Preventing E. coli Infections in Adults Aged 65 and Older

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland

  • Study of ExPEC9V vaccine for preventing invasive E.

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany The Netherlands Spain +1

Glossary

  • ExPEC: Extraintestinal Pathogenic Escherichia coli, a type of E. coli bacteria that can cause infections outside the intestinal tract, such as urinary tract infections and bloodstream infections.
  • Invasive E. coli Disease (IED): A serious infection caused by E. coli bacteria that spreads beyond the initial site of infection, such as into the bloodstream or other normally sterile sites in the body.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Reactogenicity: The capacity of a vaccine to produce common, expected adverse reactions, usually mild and self-limited, such as pain at injection site or fever.
  • Urinary Tract Infection (UTI): An infection affecting any part of the urinary system, including kidneys, bladder, ureters, and urethra, most commonly caused by bacteria like E. coli.
  • Pyelonephritis: A type of urinary tract infection that affects one or both kidneys, typically causing more severe symptoms than a simple bladder infection.
  • Bacteremia: The presence of bacteria in the bloodstream, which can lead to serious complications if not treated promptly.
  • Sepsis: A life-threatening condition that occurs when the body's response to infection causes widespread inflammation and organ dysfunction.
  • Health-related Quality of Life (HRQoL): A multi-dimensional concept that includes domains related to physical, mental, emotional, and social functioning, going beyond direct measures of health to focus on the quality of one's life experience.
  • Placebo: An inactive substance or treatment used in clinical trials as a control to compare against the effects of the investigational drug or vaccine.

References

  1. http://clinicaltrials.eu/trial-id/2023-504168-40-00
  2. http://clinicaltrials.eu/trial/study-on-jnj-78901563-vaccine-for-preventing-invasive-e-coli-disease-in-adults-60-with-recent-urinary-tract-infections/