Are you 60 years of age or older? Help us find a way to prevent blood infections.
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 aged 60 or over. 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.
Currently, there is no approved vaccine to prevent blood infections caused by E. coli bacteria. Your participation in this study is a potential step toward finding a safe and effective vaccine to prevent blood infections 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 two years
Additional eligibility criteria will be assessed by the study team.
If you are found eligible to participate in the E.mbrace Study, you will be in the study for approximately 3 years.
- You may begin screening up to 8 days before vaccination.
- On Day 1, you will receive the investigational vaccine or placebo (a vaccine that contains no active drug) in a single injection.
- You will complete a minimum of 8 study visits, some in person and some remotely via telephone.
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.
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 will analyse the study information in order to determine whether the medication is safe and effective, and if the benefits outweigh the risks, prior to approval of the vaccine for general public use.
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 defences to help build resistance to specific infections and makes your immune system stronger. Most vaccines are given as an injection (like this one).
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.
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. Urosepsis occurs when bacteria from a UTI enter the bloodstream, causing a systemic infection. UTIs are usually localised infections that affect the urinary tract, but if left untreated or if the infection becomes severe, bacteria can enter the bloodstream and spread throughout the body. 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-coloured — 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
Licensed (and not live) vaccines, such as the Pfizer and Moderna bivalent vaccines against COVID-19, may be taken at least 14 days before or after planned date of the study vaccination. Licensed live vaccines or vaccines authorised for emergency use (e.g., EUA, CMA or a similar programme) are permitted when given at least 28 days before or after the planned administration of the study vaccination.
Doctors and specialists worldwide will conduct the study on behalf of Janssen Research & Development (a pharmaceutical company of Johnson & Johnson), the sponsor of the E.mbrace Study.
Participation 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 research study 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.
