Content on this website is intended for United Kingdom residents only.

Are you 60 years of age or older? Help us find a way to prevent bloodstream infections.

People aged 60 years or older, with a history of UTI, are at an increased risk of developing a bloodstream infection, caused by an E. coli bacteria.

See if you pre-qualify

embrace-img
About the E.mbrace Study

The E.mbrace Study will assess the effectiveness and safety of an investigational vaccine versus a placebo – a vaccine that contains no active drug but which will look exactly like the investigational vaccine – in the prevention of a bloodstream infection in adults aged 60 or over who have had a urinary tract infection (UTI) in the past two years. The investigational vaccine or placebo will be given as a single injection.

Who can participate in this study?

Both men and women who have experienced a urinary tract infection (UTI) may be eligible to participate in the E.mbrace Study, if they:

  • Are 60 years of age or older
  • Have had a UTI in the past 2 years
  • Feel comfortable, or have a caregiver who is comfortable, using a web-based program on a computer or tablet, or an application on a smartphone

If you are interested, additional eligibility criteria will be assessed by the study doctor or staff.

What can participants expect?

If you are found to be eligible to participate in the E.mbrace Study, you will receive the investigational vaccine or placebo in a single injection and complete a minimum of eight study visits – some in person and some remote, using a smartphone, computer or tablet. The commitment period for the study is approximately three years. Visit type – whether in-person or remote – will be determined by the study team. Your study team will update you on the contacts and clinic visits required for your participation.

Study participants and/or their carer will be required to use either a web-based (laptop, computer or tablet) or smartphone application to record and share information with their study team. This technology is called a Mobile Health Platform (MHP) and will be used throughout the study.

What is vaccination and why is it important?

Vaccination is a way of helping to prevent or lesson diseases in people before they come into contact with them. It uses your body’s natural defences to help build resistance to specific infections and makes your immune system stronger. Most vaccines are given as an injection, but some are given orally (by mouth) or sprayed into the nose.

What is a clinical research study?

A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical trials are conducted by doctors and researchers. The results of clinical studies help regulatory agencies like the UK Medicines and Healthcare products Regulatory Agency (MHRA) to decide if an investigational drug should be approved and made available to patients. Clinical trials are the only way we can develop new and better treatments and improve patient care. Clinical studies are generally reviewed by an independent review board (IRB) or by Ethics Committees (ECs). The purpose of the IRB or EC review is to ensure that the appropriate steps are taken to protect the rights and welfare of humans participating in clinical studies. Clinical studies are conducted by experienced and trained medical professionals who monitor the health of participants during the study.

The importance of diversity in clinical research studies

Research has shown that certain diseases, treatments and medications may impact people differently based on their age, gender and genetic background, including race and ethnicity. It is important to conduct research studies with diverse populations to help ensure that vaccines and medications are generally safe and effective (or that the benefits outweigh the risks) for the populations that will be using them.

Why is clinical research important?

Clinical studies often require a large number of volunteers to participate in a single study; sometimes thousands are needed to obtain reliable information. This information is then submitted to the MHRA and other local regulatory authorities. They analyse the information in order to determine whether the medication is safe and effective, or if the benefits outweigh the risks, in order to provide approval for public use.

Frequently asked questions

Janssen Research & Development is responsible for conducting this clinical study.

Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, for any reason.

Qualified participants may receive the investigational vaccine or a placebo and some study-related medical care at no cost. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.

Every clinical trial must be reviewed – and is continually monitored – by a regulatory review committee, to ensure that the risks to the study participant are as low as possible. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason.

Urinary tract infections don’t always cause signs and symptoms, but when they do, they may include:

  • A strong, persistent urge to urinate
  • A burning sensation when urinating
  • Passing frequent, small amounts of urine
  • Urine that appears cloudy
  • Urine that appears red, bright pink or cola-colored — a sign of blood in the urine
  • Strong-smelling urine
  • Pelvic pain, in women — especially in the centre of the pelvis and around the area of the pubic bone

Urinary tract infections (UTI) are a common type of infection that can be treated easily with antibiotics. Sometimes, though, the bacteria that caused the UTI can infect your bloodstream. This condition is called urosepsis and can be life-threatening.

ExPEC is a bacteria that belongs to E. coli bacteria. ExPEC stands for Extraintestinal Pathogenic Escherichia coli disease, and it is a leading and increasing cause of infections worldwide. It has the potential to infect the bloodstream or other sites of the human body. The potentially severe forms of infections caused by ExPEC are grouped under the term Invasive ExPEC disease (IED).

We use cookies to give you the best online experience. If you disable the cookies, you may not be able to access some parts of the website. It may also not work as intended. You can find out more about how to manage and delete cookies by visiting https://www.youronlinechoices.com/uk/. Your use of this site is subject to our posted Terms of Use. Please also see our Privacy Notice.