Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Summary
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: * To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \>= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: * To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. * To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: * To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: * To describe the safety profile of all participants who received at least 1 injection.
Timeline
- Start
- 2013-07-30
- Primary completion
- 2018-06-12
- Completion
- 2018-06-12
Outcome
Missed primary endpoint
Stopped: “The Independent Data Monitoring Committee (IDMC) concluded that the probability that the study will meet its primary objective is low.”
paper In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection. PMID 32946836 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | C. difficile Toxoid Vaccine | Vaccine | 0.5 ml | Intramuscular |