This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives: * To describe the safety profile of subjects in each of the study groups. * To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups. Observational Objective: * To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.
Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™ vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different vaccination schedules using one of these formulations. Participants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
650
0.5 mL, Intramuscular on Days 0, 7, and 30
0.5 mL, Intramuscular on Days 0, 7, and 30
0.5 mL, Intramuscular on Days 0, 7, and 30
0.5 mL, Intramuscular on Days 0, 7, and 30
0.5 mL, Intramuscular on Days 0, 7, and 30
0.5 mL, Intramuscular on Days 0, 7, and 180
0.5 mL, Intramuscular on Days 0, 30, and 180
Unnamed facility
Redding, California, United States
Unnamed facility
Bristol, Connecticut, United States
Unnamed facility
Stamford, Connecticut, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Port Orange, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Idaho Falls, Idaho, United States
...and 20 more locations
Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.
Time frame: 6 days after each vaccination and up to 6 months post-vaccination 3
Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™.
Time frame: Up to 6 months post-vaccination 3
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