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ExPEC9V is an investigational vaccine being studied for its potential to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease in older adults. This article summarizes key information from two clinical trials evaluating the safety, efficacy, and immunogenicity of ExPEC9V in adults aged 60 and older, particularly those with a history of urinary tract infections. The trials aim to assess how well ExPEC9V can protect against serious E. coli infections when given alone or alongside a flu vaccine.

Table of Contents

What is ExPEC9V?

ExPEC9V is an investigational vaccine being developed to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease in older adults[1]. This vaccine, also known as JNJ-78901563, is a solution for injection that contains nine different components targeting various strains of E. coli bacteria[2].

Who is ExPEC9V designed for?

ExPEC9V is primarily being studied in adults aged 60 years and older who have a history of urinary tract infections (UTIs) in the past two years[2]. This group is particularly vulnerable to invasive E. coli infections, which can lead to serious health complications. The vaccine is especially targeted at individuals who have additional risk factors for invasive ExPEC disease, such as:

  • A history of urosepsis (a severe infection that starts in the urinary tract and spreads to the bloodstream) or E. coli bacteremia (presence of E. coli in the blood)
  • Recent hospitalization
  • Presence of factors that increase the risk of complicated UTIs

How does ExPEC9V work?

ExPEC9V is designed to stimulate the immune system to produce antibodies against nine specific types (serotypes) of E. coli bacteria: O1, O2, O4, O6, O15, O16, O18, O25, and O75[1][2]. These serotypes are commonly associated with invasive ExPEC infections. By generating an immune response against these bacteria, the vaccine aims to prevent or reduce the severity of infections caused by these E. coli strains.

Current Clinical Trials

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

  1. A study comparing ExPEC9V with a high-dose quadrivalent seasonal influenza vaccine in adults aged 65 years or older[1].
  2. A randomized, double-blind, placebo-controlled study in adults aged 60 years and older with a history of UTIs[2].

These trials aim to determine if ExPEC9V can effectively prevent invasive ExPEC disease, including infections in the blood, other sterile sites, or urine caused by the targeted E. coli serotypes.

Potential Benefits of ExPEC9V

If successful, ExPEC9V could offer several benefits to older adults:

  • Reduced risk of invasive E. coli infections, including bloodstream infections and severe UTIs
  • Decreased hospitalizations due to E. coli-related illnesses
  • Lower incidence of sepsis caused by ExPEC strains
  • Improved quality of life for those prone to recurrent UTIs
  • Potential reduction in antibiotic use, which could help combat antibiotic resistance

Safety and Side Effects

As with any vaccine, safety is a crucial consideration. The ongoing clinical trials are closely monitoring for any adverse effects. Common side effects of vaccines may include:

  • Pain, redness, or swelling at the injection site
  • Mild fever
  • Fatigue
  • Headache
  • Muscle aches

The trials are specifically looking at both local reactions (at the injection site) and systemic reactions (affecting the whole body) for up to 14 days after vaccination[2]. Long-term safety is also being evaluated throughout the study period.

Future Prospects

If ExPEC9V proves to be safe and effective in preventing invasive E. coli infections, it could become an important tool in protecting older adults from these potentially serious diseases. The vaccine could be particularly valuable for those with recurrent UTIs or other risk factors for invasive ExPEC infections.

As research continues, more information will become available about the vaccine’s effectiveness, duration of protection, and any potential need for booster doses. The results of these clinical trials will be crucial in determining whether ExPEC9V becomes available as a preventive option for older adults at risk of invasive E. coli 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, single dose or co-administered with flu vaccine
E. coli Serotypes Targeted O1, O2, O4, O6, O15, O16, O18, O25, and O75
Key Outcomes Measured Invasive E. coli disease events, hospitalizations, quality of life, immune response
Safety Monitoring Local and systemic adverse events, serious adverse events
Study Duration Up to 3 years of follow-up

FAQ

  • What is ExPEC9V? ExPEC9V is an investigational vaccine designed to prevent invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease. It contains components targeting nine E. coli serotypes: O1, O2, O4, O6, O15, O16, O18, O25, and O75.
  • Who is being studied in 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. This population is at higher risk for invasive E. coli infections.
  • What are the main goals of these studies? The primary objectives are to evaluate the efficacy of ExPEC9V in preventing invasive E. coli disease, assess its safety and immune response, and determine if it can be given safely alongside a flu vaccine in older adults.
  • How is the vaccine administered? ExPEC9V is given as an intramuscular injection. In one study, it's given as a single dose, while in another, it's being evaluated both alone and co-administered with a high-dose quadrivalent influenza vaccine.
  • What potential benefits are being studied? The studies are investigating if ExPEC9V can reduce the occurrence of invasive E. coli disease, including bloodstream infections, urinary tract infections, and other serious infections caused by the targeted E. coli serotypes. They're also looking at its impact on hospitalization rates and quality of life in older adults.

Ongoing Clinical Trials on Ecoo25B

  • 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

  • ExPEC9V: An investigational vaccine targeting nine serotypes of extraintestinal pathogenic Escherichia coli (E. coli) to prevent invasive disease.
  • Invasive Extraintestinal Pathogenic Escherichia coli (ExPEC) Disease: Serious infections caused by E. coli bacteria outside the intestines, such as in the blood, urinary tract, or other body sites.
  • Serotype: A distinct variation within a species of bacteria, identified by specific surface structures. ExPEC9V targets nine E. coli serotypes: O1, O2, O4, O6, O15, O16, O18, O25, and O75.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Quadrivalent Influenza Vaccine: A flu vaccine that protects against four different influenza viruses.
  • Bacteremia: The presence of bacteria in the bloodstream, which can lead to serious infections.
  • Pyelonephritis: A type of urinary tract infection that affects one or both kidneys.
  • Urosepsis: A severe infection that starts in the urinary tract and spreads to the bloodstream, potentially causing a life-threatening condition.
  • Health-related Quality of Life (HRQoL): A measure of how a person's health affects their overall well-being and ability to function in daily life.
  • Frailty Index: A measure used to assess an older person's overall health status and vulnerability to adverse outcomes.

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/