Purpose of this Study
Each person in the study will take part for about three and a half years. They will go to the clinic three times: the first time for the first shot, the second time six months later for the second shot, and the third time one month after the second shot to check safety. There will also be three phone calls to check on safety at 1 month, 12 months, and 18 months after the first shot. After that, people will visit the clinic once a year until the study ends.
Who Can Participate?
Eligibility
People can join if they have a higher chance of getting a C. Diff infection. This can happen if they stayed in the hospital for at least two nights in the past year, went to the emergency room two or more times in the past year, or had ten or more doctor visits in the past year. They can also join if they took antibiotics for two days or more in the past 12 weeks, or if they have a hospital stay or surgery planned at least 14 days after their second vaccine.
Age Range
65-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
This is a big study to test a new vaccine that may help prevent a sickness called C. difficile. The study will check if the vaccine works well, is safe, and does not cause bad side effects. People in the study will get two shots, six months apart. Some people will get the real vaccine, and others will get a shot of salty water called placebo. The study will include about 30,000 people who are 65 years or older, and at least 4,000 of them will be 75 years or older.
Locations
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A PHASE 3, PLACEBO CONTROLLED, DOUBLE BLINDED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIOIDES DIFFICILE VACCINE IN ADULTS 65 YEARS OF AGE AND OLDER.
Principal Investigator
Emmanuel
Walter
Protocol Number
PRO00118801
Phase
III
Enrollment Status
Pending Open to Enrollment