Investigational Vaccine Study for Adults (65+)
Researchers at NYU Langone Health are conducting a clinical study to determine whether an investigational vaccine can help protect adults 65 years of age and older against Clostridioides difficile infection.
Fast Facts
You may qualify if you are 65+ and have had at least two emergency room visits or multiple doctor visits or have taken antibiotics recently
Compensation
Provided Up To $1510
Conducted in
Manhattan & Brooklyn
Study Background
C. difficile is a serious infection that can cause severe diarrhea, especially in older adults receiving medical care.
C. difficile infection is one of the most common healthcare-associated infections. It often occurs after antibiotic use or hospital stays and can lead to severe diarrhea, dehydration, and additional medical complications. Adults over 65 are at higher risk for serious illness and hospitalization related to this infection. Currently, there is no approved vaccine available to prevent C. difficile infection.
This research study is evaluating an investigational vaccine designed to help prevent severe diarrhea caused by C. difficile and potentially reduce how sick someone becomes if they do get infected. Researchers will also study whether the vaccine is well tolerated and whether it may reduce the need for antibiotics or additional medical care. Participants will be followed for approximately 3.5 years to better understand the vaccine’s long-term effects.
Study Background
C. difficile is a serious infection that can cause severe diarrhea, especially in older adults receiving medical care.
C. difficile infection is one of the most common healthcare-associated infections. It often occurs after antibiotic use or hospital stays and can lead to severe diarrhea, dehydration, and additional medical complications. Adults over 65 are at higher risk for serious illness and hospitalization related to this infection. Currently, there is no approved vaccine available to prevent C. difficile infection.
This research study is evaluating an investigational vaccine designed to help prevent severe diarrhea caused by C. difficile and potentially reduce how sick someone becomes if they do get infected. Researchers will also study whether the vaccine is well tolerated and whether it may reduce the need for antibiotics or additional medical care. Participants will be followed for approximately 3.5 years to better understand the vaccine’s long-term effects.
Additional Information
This study is being done to learn whether an investigational vaccine can prevent C. difficile infection or make the infection less severe in adults 65 and older.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 65+
- Have had at least one of the following: have gone to the doctor many times in the past year, stayed in the hospital at least once in the past year, went to the emergency room at least two times in the past year, used antibiotics in the past 12 weeks, or have a planned procedure or surgery in the next year that will require them to stay in the hospital for at least 2 nights
- Have not had C. difficile infection in the past
- You should not have a health condition or treatment that often leads to diarrhea
If you qualify and choose to participate:
You will attend at least 5 in-person clinic visits in Manhattan or Brooklyn.
You will complete 2 to 3 phone visits for additional check-ins.
You will receive 2 shots, about 6 months apart. You will receive either the study vaccine or a placebo (a shot with no active medicine).
You will be followed for about 3.5 years after your last shot.
You will monitor your bowel movements using the Bristol Stool Chart and report any diarrhea during the study.
You may be asked to provide blood samples so researchers can measure your immune response.
You will complete short electronic diaries (eDiaries) to report symptoms and health updates.
A member of the study team will conduct a phone interview to determine if you qualify before scheduling your first visit.
You may receive up to $1,510 for completing all study-related activities.
Compensation includes:
$150 for each completed in-person visit
$50 for each completed phone visit
$150 for completing an in-person or phone visit if you experience more than 3 loose stools within 24 hours
$75 for completing the vaccine eDiary for 7 consecutive days
$10 per month for completing required diarrhea eDiary check-ins
Participants may also receive small study-branded gifts such as towels or reusable water bottles, as well as snacks or drinks during study visits.
Throughout the study, participants are supported by a dedicated vaccine research center team, including infectious disease specialists and research nurses.
There is no cost for you to participate in our research study.