Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years
This research is a large study looking at a new vaccine named JNJ-78901563. The vaccine aims to protect people aged 60 and older from serious infections caused by specific types of E. coli bacteria, especially if they've had urinary tract infections (UTIs) in the past two years. Participants will either receive the vaccine or a harmless salt solution (placebo) to see if the vaccine works. Researchers will also check for any side effects and how well the body's immune system responds. The main goal is to see if the vaccine can prevent the first serious E. coli infection that affects organs beyond the bladder, like the blood or kidneys.
At a glance
What is this study about?
This study is about understanding if a new vaccine, called JNJ-78901563, can help prevent serious infections caused by a common type of bacteria called E. coli. Often, E. coli causes urinary tract infections (UTIs), but it can sometimes lead to more severe problems if it spreads to other parts of the body, like the bloodstream or kidneys. These are known as 'invasive extraintestinal pathogenic E. coli infections' or IEDs.
The researchers want to see if this vaccine can protect older adults, specifically those aged 60 and above who have a history of UTIs. This group is chosen because they might be more vulnerable to these types of severe infections. The study will compare the vaccine to a 'placebo', which is a harmless salt solution that looks just like the vaccine but contains no active ingredients. This helps researchers figure out if any effects they see are truly due to the vaccine or something else.
The main thing the study will measure is whether the vaccine reduces the number of participants who get a serious E. coli infection that has spread beyond the urinary tract. They will also keep a close eye on any side effects people experience and how well the vaccine helps the body build protection against these specific E. coli strains. By doing this, they hope to find a new way to keep older adults healthier and prevent these potentially dangerous infections.
Key takeaways
- Tests a new vaccine (JNJ-78901563) to prevent serious E. coli infections.
- Aimed at adults aged 60 and over with a history of UTIs.
- Compares the vaccine to a harmless salt solution (placebo).
- Looks for effectiveness in preventing infections and any side effects.
- Involves regular clinic visits and blood tests over several years.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 60 years or older. You should also have a history of urinary tract infections within the last two years. The study is open to both men and women.
There might be other health conditions or medications that would prevent you from taking part, but the study team will discuss all of these with you in detail. They will check your medical history to make sure the study is a safe option for you.
- Are you 60 years old or older?
- Have you had a urinary tract infection (UTI) in the last two years?
- Are you able to attend regular clinic appointments for several years?
- Are you willing to receive injections and have blood tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned by chance to either receive the new vaccine or a harmless salt solution (placebo). Neither you nor the study team will know which one you are getting. You will receive a few injections over time.
Throughout the study, you will have regular visits to the clinic where doctors and nurses will monitor your health. This will include blood tests to check how your body is responding to the vaccine and to see if you develop any E. coli infections. They will also ask you questions about your health and any side effects you might experience, especially in the first few weeks after each injection.
The study will last for several years, with follow-up visits happening on a set schedule to track your health over time. You'll complete questionnaires about your quality of life at certain points. You can withdraw from the study at any time.
Potential risks and benefits
Locations (7)
- —Netherlands
- —Czechia
- —Germany
- —Spain
- —France
- —Sweden
- —Denmark
Common questions
What is E. coli?
E. coli is a common type of bacteria that usually lives harmlessly in our gut. However, some types can cause infections, especially urinary tract infections (UTIs) or, in serious cases, spread to other parts of the body.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study treatment (in this case, the vaccine) but has no active ingredients. It's used to fairly compare the real treatment's effects.
Will I know if I'm getting the vaccine or the placebo?
No, during the study, neither you nor the doctors will know whether you received the vaccine or the placebo. This is called 'double-blind' and helps ensure the study results are accurate.
How long will I be in the study?
The study involves follow-up for several years, with scheduled visits along the way to monitor your health and the vaccine's effects over time.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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