EMBRACE

Description

A phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, and immunogenicity of a vaccine (ExPEC9V) for the prevention of invasive infections caused by Escherichia coli in older adults.

Target

The study aims to determine whether an investigational vaccine (ExPEC9V) is effective in preventing the first episode of invasive infection caused by Escherichia coli in people over the age of 60. These infections can be serious and lead to complications such as bacteremia or sepsis, especially in patients with a history of urinary tract infections.

To whom it is addressed

This study is designed for people who:

• They are 60 years old or older.
• They have had at least one urinary tract infection in the past 2 years.
• They are at greater risk of developing serious E. coli infections.

Treatment

Participants are randomly assigned to one of two groups:

• Vaccine group (ExPEC9V): They receive one dose of the investigational vaccine.
• Placebo group: They receive an injection containing no active ingredient.

What are these treatments?

ExPEC9V:
This is an experimental vaccine designed to protect against invasive infections caused by different types of Escherichia coli. It works by stimulating the immune system to prevent serious infections before they occur.

Placebo:
It is a substance with no active ingredient that is administered to compare results and objectively evaluate the vaccine's efficacy.

Study phases

Initial evaluation (screening):
Medical tests and a clinical evaluation are conducted to confirm that the participant meets the study criteria.

Randomization and vaccination:
Participants are randomly assigned to one of the groups and receive either the vaccine or a placebo.

Follow-up:
Long-term follow-up is conducted to detect potential infections, evaluate the immune response, and monitor the safety of the treatment.

Duration of the study

The total duration of the study may extend to approximately 6 years and 9 months, including post-vaccination follow-up.

What is evaluated

• Onset of the first episode of invasive E. coli infection.
• Vaccine safety (adverse effects).
• Immune system response (immunogenicity).