Are you 60 years of age or older? Help us find a way to prevent infections in the blood.
A clinical research study to evaluate an investigational vaccine in adults 60 years of age or older is now enrolling.
The E.mbrace Study will assess the effectiveness and safety of an investigational vaccine in the prevention of blood infections in adults 60 years of age or older. These blood infections can lead to serious complications such as dangerously low blood pressure or shock.
These infections are called an invasive (also known as systemic) infection, often referred to as an invasive E. coli disease (IED). 1 Although IED affects all ages, adults aged 60 years and older have an increased risk of developing IED, which is further increased if you have had a urinary tract infection (UTI) in the past.
What we learn in this study may be helpful for blood infection prevention in the future.
You may be eligible to participate in the E.mbrace Study if you:
- 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 an application on a smartphone
Additional eligibility criteria will be assessed by the study team.
If you are found eligible to participate in the E.mbrace Study, on Day 1 you will receive the investigational vaccine or placebo (a vaccine that contains no active drug) in a single injection. You will also complete a minimum of 8 study visits, some in person and some remote via telephone. The commitment for the study is approximately 3 years. The type of visits, in-person and remotely, will be determined by the study team. Your study team will update you regarding the contacts and clinic visits required for your participation.
Study participants and/or their caregiver will be required to use a smartphone application to record and share information with their study team.
Vaccination is a way of helping to prevent or lessen diseases in people before they come into contact with them. It uses your body’s natural defenses to help build resistance to specific infections and makes your immune system stronger. Most vaccines are given by an injection, but some are given orally (by mouth) or sprayed into the nose.
A clinical research study is a carefully designed scientific evaluation of an investigational medication or treatment. Clinical research studies are conducted by doctors and researchers. The results of clinical research studies help regulatory agencies like the U.S. Food and Drug Administration (FDA) decide if an investigational drug should be approved and made available to patients. Clinical research studies are the only way we can develop new and better treatments and improve patient care. Clinical research studies are generally reviewed by an independent review board (IRB) or Ethics Committees (ECs). The purpose of the IRB or EC review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating in clinical research studies. Clinical research studies are conducted by experienced and trained medical professionals who monitor the health of participants during the study.
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 the benefits outweigh the risks) for the populations that will be using them.
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 FDA and other local regulatory authorities. They analyze 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
Escherichia coli (E. coli) are bacteria commonly found in the human gut. Some strains of E. coli bacteria can also go into the urinary tract and cause a urinary tract infection (UTI).
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 blood. This condition is called urosepsis and can be life-threatening. Antibiotic resistance, meaning that there may be few or no effective antibiotics, is becoming more common and may lead to a greater risk for a blood infection.
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 center of the pelvis and around the area of the pubic bone
Doctors and specialists will conduct the study on behalf of Janssen Research & Development (a pharmaceutical company of Johnson & Johnson), the sponsor of the E.mbrace 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, and for any reason.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason.
Qualified participants may receive the investigational vaccine or placebo and some study-required 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.