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Ecoo16

Clinical trials are underway to evaluate the effectiveness of a new vaccine called ExPEC9V in preventing invasive extraintestinal pathogenic Escherichia coli (E. coli) disease in older adults. This vaccine, which contains the active substance ECOO16 among others, is being tested in adults aged 60 and older who have a history of urinary tract infections. The trials aim to assess the vaccine’s ability to prevent serious E. coli infections, its safety profile, and its impact on patients’ quality of life.

Table of Contents

What is ExPEC9V?

ExPEC9V (also known as JNJ-78901563) is an investigational vaccine being developed to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease in older adults[1]. This vaccine is designed to target specific strains of E. coli bacteria that can cause serious infections outside the intestinal tract.

The vaccine contains nine different components (O-serotypes) of E. coli bacteria: ECOO1A, ECOO2, ECOO4, ECOO6A, ECOO15, ECOO16, ECOO18A, ECOO25B, and ECOO75[1]. These components are carefully selected to provide protection against the most common and problematic strains of ExPEC.

Who is ExPEC9V intended for?

ExPEC9V is primarily being studied for use in adults aged 60 years and older who have a history of urinary tract infections (UTIs)[2]. This group is particularly vulnerable to invasive E. coli infections due to factors such as:

  • Weakened immune systems
  • Increased susceptibility to UTIs
  • Higher risk of complications from bacterial infections

The vaccine may be especially beneficial for older adults who have additional risk factors for invasive ExPEC disease, such as:

  • A history of E. coli bloodstream infections (bacteremia) or urosepsis
  • Recent hospitalization
  • Presence of conditions that increase the risk of complicated UTIs

How does ExPEC9V work?

ExPEC9V is designed to stimulate the immune system to produce antibodies against the nine specific O-serotypes of E. coli included in the vaccine. These antibodies help the body recognize and fight off these harmful bacteria more effectively if exposed to them in the future.

The vaccine is administered as an intramuscular injection, typically in the upper arm (deltoid muscle)[1]. It is given as a single dose, which may make it more convenient for older adults compared to vaccines that require multiple doses.

Current Clinical Trials

ExPEC9V is currently being evaluated in Phase 3 clinical trials, which are large-scale studies designed to assess the vaccine’s effectiveness and safety in a broader population. Two notable trials are:

  1. A study comparing ExPEC9V with a high-dose quadrivalent influenza vaccine in adults aged 65 years or older[1]. This trial aims to:

    • Evaluate the immune response to both vaccines when given together or separately
    • Assess the safety and reactogenicity (expected short-term side effects) of the vaccines

  2. A large-scale study in adults aged 60 years and older with a history of UTIs[2]. This trial is designed to:

    • Determine if ExPEC9V can prevent invasive E. coli infections
    • Evaluate the vaccine’s ability to reduce UTIs and other E. coli-related illnesses
    • Assess the long-term safety and effectiveness of the vaccine

Potential Benefits of ExPEC9V

If proven effective, ExPEC9V could offer several benefits to older adults:

  • Reduced risk of serious E. coli infections, including those affecting the blood, kidneys, and other organs
  • Fewer hospitalizations due to E. coli-related illnesses
  • Decreased incidence of UTIs and associated complications
  • Improved quality of life for those prone to recurrent UTIs or at risk for invasive E. coli infections
  • Potential reduction in antibiotic use, which could help combat antibiotic resistance

Safety and Side Effects

As with any vaccine, safety is a top priority in the development of ExPEC9V. The ongoing clinical trials are carefully monitoring for any adverse effects. Some potential side effects that may occur include:

  • Pain, redness, or swelling at the injection site
  • Mild fever or fatigue
  • Headache or muscle aches

These side effects are typically mild and short-lived. The clinical trials will provide more comprehensive information about the vaccine’s safety profile and any rare or unexpected side effects.

Conclusion

ExPEC9V represents a promising advancement in the prevention of invasive E. coli infections in older adults. As the clinical trials progress, more information will become available about its effectiveness and safety. If successful, this vaccine could significantly improve the health and well-being of many older adults who are at risk for these serious infections.

It’s important to note that while the vaccine shows promise, it is still under investigation and not yet approved for general use. Patients should continue to follow their healthcare provider’s advice regarding prevention and treatment of UTIs and other E. coli-related infections.

Aspect Details
Vaccine Name ExPEC9V (JNJ-78901563)
Target Population Adults aged 60 years and older with a history of urinary tract infections
Primary Objectives Prevent invasive E. coli disease, evaluate safety and immunogenicity
Administration Intramuscular injection
Key Components ECOO1A, ECOO2, ECOO4, ECOO6A, ECOO15, ECOO16, ECOO18A, ECOO25B, ECOO75
Study Design Randomized, double-blind, placebo-controlled Phase 3 trials
Follow-up Duration Up to 3 years post-vaccination
Key Outcomes Prevention of invasive E. coli disease, urinary tract infections, and related hospitalizations

FAQ

  • What is ExPEC9V? ExPEC9V is a vaccine being developed to prevent invasive extraintestinal pathogenic Escherichia coli (E. coli) disease. It contains multiple components, including ECOO16, that target different strains of E. coli bacteria.
  • Who is being included in these clinical trials? The trials are focusing on adults aged 60 years and older who have a history of urinary tract infections in the past 2 years. Participants must also have at least one additional risk factor for invasive E. coli disease.
  • How is the vaccine administered? The ExPEC9V vaccine is administered as an intramuscular injection. In the trials, participants receive either the vaccine or a placebo.
  • What are the main goals of these clinical trials? The primary goals are to evaluate the vaccine's effectiveness in preventing invasive E. coli disease, assess its safety and immune response, and determine its impact on participants' health-related quality of life.
  • How long will participants be followed in these studies? Participants will be followed for several years after vaccination. The studies include assessments at various time points, including Day 30, Day 181, Year 1, Year 2, and Year 3 after vaccination.

Ongoing Clinical Trials on Ecoo16

  • 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

  • Extraintestinal pathogenic Escherichia coli (ExPEC): A type of E. coli bacteria that can cause infections outside the intestines, such as urinary tract infections, bloodstream infections, and other serious conditions.
  • 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 body sites.
  • Urinary Tract Infection (UTI): An infection that affects any part of the urinary system, including the kidneys, bladder, and urethra. UTIs are often caused by E. coli bacteria.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Placebo: An inactive substance that looks like the real medicine but has no medical effect. It is used in clinical trials to compare the effects of a new treatment against no treatment.
  • Bacteremia: The presence of bacteria in the bloodstream, which can lead to serious infections throughout the body.
  • Pyelonephritis: A type of urinary tract infection that affects one or both kidneys.
  • Sepsis: A life-threatening condition that occurs when the body's response to infection causes widespread inflammation and organ failure.

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/