Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
|ClinicalTrials.gov Identifier: NCT01887912|
Recruitment Status : Active, not recruiting
First Posted : June 27, 2013
Last Update Posted : February 6, 2018
The aim of this study is to evaluate the efficacy of the candidate Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in subjects a risk for CDI where there is a substantial unmet medical need.
- 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 subjects aged ≥ 50 years who are at risk for CDI and have received at least 1 injection.
- 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.
- To describe the immunogenicity to toxin A and toxin B in the subset of subjects at specific time points.
- To describe the safety profile of all subjects who receive at least 1 injection.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Biological: C. difficile Toxoid Vaccine Biological: Placebo: 0.9% normal saline||Phase 3|
The study is designed as an event-driven group sequential protocol with 4 interim analyses at defined information milestones and a final analysis when a specific number of clinical endpoints are reached.
Subjects will be randomly assigned to receive either the candidate vaccine or a placebo that will be administered in a 3-dose schedule.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||May 16, 2018|
|Estimated Study Completion Date :||May 16, 2018|
Experimental: C. difficile Vaccine Group
Participants will receive 1 injection of the C. difficile toxoid vaccine at Days 0, 7, and 30, respectively.
Biological: C. difficile Toxoid Vaccine
0.5 mL, Intramuscular
Placebo Comparator: Placebo Vaccine Group
Participants will receive 1 injection of placebo (0.9% normal saline) at Days 0, 7, and 30, respectively.
Biological: Placebo: 0.9% normal saline
0.5 mL, Intramuscular
- Number of symptomatic PCR-confirmed primary CDI cases after at least one injection [ Time Frame: Up to 3 years post-vaccination 1 ]Presence of ≥ 3 loose stools for ≤ 24 hours and loose stools lasting ≥ 24 hours, and stool sample positive for C. difficile PCR, or confirmatory test of pseudomembranous colitis diagnosed through colonoscopy, and, if available, provision of a stool sample for PCR-testing
- Number of symptomatic PCR-confirmed primary CDI cases after 3 injections [ Time Frame: Up to 3 years post-vaccination 3 ]
- Number of symptomatic PCR-confirmed primary CDI cases after at least 2 injections [ Time Frame: Up to 3 years post-vaccination 2 ]
- Number of symptomatic PCR-confirmed primary CDI cases after 3 injections since enrollment and within 3 years after the third injection [ Time Frame: Up to 3 years post-vaccination 3 ]
- Number of severe PCR-confirmed primary CDI cases [ Time Frame: Up to 3 years post-vaccination 3 ]A severe case is defined when a subject has one or more of the following; fever ≥38.5°C, WBC count ≥ 15,000 cells/mm3 (if available), ileus, pseudomembranous colitis, serum albumin <3 g/dl, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis
- Maximum number of loose stools per day associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]Effect of the vaccine on reduction of loose stool frequency
- CDI episode/illness duration associated with a symptomatic PCR-confirmed primary CDI case [ Time Frame: Up to 3 years post-vaccination 3 ]Duration is calculated as (clinical cure date - clinical case date + 1)
- Immunogenicity to toxins A and toxin B [ Time Frame: Day 0 to Day and every 6 months up to 3 years ]Antibody concentrations against toxins A and B measured by ELISA and antibody titers measured by toxin neutralization assay in subsets of subjects
- Number of participants reporting solicited injection site and systemic reactions [ Time Frame: Day 0 to Day 6 after each injection ]Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887912
Show 335 Study Locations
|Study Director:||Medical Director||Sanofi Pasteur Inc.|