Spending a Lot of Time at the Doctor - C. diff Vaccine
Clostridium Difficile Vaccine
Care Clinical Research Corporation and Covigilant Research LLC
What is Clostridium difficile?
C. difficile (C. diff) is one of the most common causes of healthcare-related infections.
C. diff is a type of bacteria that lives in the human intestines and its spores can survive outside of the body for months. These spores are resistant to cleaning and are most commonly
transmitted in healthcare settings. People can become infected by touching surfaces that are contaminated or by coming into contact with a healthcare worker that has the bacteria or spores
on their hands.
People most at risk of getting sick due to C. diff are those who are taking antibiotics, being treated in a healthcare facility, the elderly and people who are already ill. This infection can
cause symptoms that include frequent diarrhea, inflammation of the colon, fever, nausea and abdominal pain; in severe cases it can be life-threatening.
The Clover Trial is evaluating an investigational vaccine that may help decrease your chance of getting sick due to C. diff.
About the Clover Trial
Your participation in this study is expected to last between 18 and 42 months and will require 5 office visits within the first 7 months. You will also receive periodic contact from the study
team, including regular electronic reminders of your participation and routine telephone calls after 12 months and at the end of the study. Approximately 16,000 patients are expected to
participate in the study globally. During the study, you will be given an electronic diary and asked to record any symptoms you might be having. If you have diarrhea 3 or more times within 24
hours, you will be asked to collect a sample of the diarrhea. We will provide a kit for this and arrange for a courier to collect the sample.
You may also have the following assessments during the study period: physical exam, vital signs, urine tests and stool sample(s). All participants will be asked to provide blood
You will be randomly assigned (like the flip of a coin) to receive either the investigational study vaccine or a placebo. This product will be given to you by injection. The placebo looks like the study vaccine, but has no active ingredient in it. You will not know if you are receiving the active vaccine or the placebo.
Am I Eligible?
You may be eligible to participate in this clinical study if you:
• Are 50 years old or over
• Have had at least 2 visits to the emergency room, or had a hospitalization of at least 2 nights in the last 12 months, or
• Have a planned hospitalization that will require a stay of 2 or more nights or
• Are a resident in a nursing facility or
• Have had at least 10 outpatient visits in the last 12 months or
• Have received oral or injectable antibiotics within the last 12 weeks.
Note: These are not the only eligibility criteria for this clinical research study, and other criteria may exclude you. A clinical research team member will help determine if you meet all necessary criteria to participate.
Why Should I Participate?
The purpose of the Clover trial is to evaluate the safety and efficacy of an investigational vaccine in reducing the chances of getting sick due to C. diff. The knowledge gained from this study
may help others in the future.
The clinical research team will discuss all study risks with you and answer any additional questions you may have.
How to Participate
If you are interested in participating, you will go through a series of screening assessments to determine your eligibility.
If you qualify and choose to participate, you will be randomly assigned to receive the investigational vaccine or a placebo.
Eligible participants will receive study-related tests and procedures at no cost.