Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
Primary Purpose
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vaccine diluent buffer
Clostridium difficile toxoid vaccine (50 μg)
Clostridium difficile toxoid vaccine (100 μg)
Sponsored by
About this trial
This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine
Eligibility Criteria
Inclusion Criteria:
- Adult males or females, 18 - 55 years in good general health
Exclusion Criteria:
- Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
- Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
- Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo vaccine group
Clostridium Difficile Vaccine Group 1
Clostridium Difficile Vaccine Group 2
Arm Description
Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Outcomes
Primary Outcome Measures
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00772954
Brief Title
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
Official Title
A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Issues with CTM stability.
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
Detailed Description
This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Keywords
Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo vaccine group
Arm Type
Placebo Comparator
Arm Description
Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
Arm Title
Clostridium Difficile Vaccine Group 1
Arm Type
Experimental
Arm Description
Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Arm Title
Clostridium Difficile Vaccine Group 2
Arm Type
Experimental
Arm Description
Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Vaccine diluent buffer
Intervention Description
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile toxoid vaccine (50 μg)
Intervention Description
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile toxoid vaccine (100 μg)
Intervention Description
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
Primary Outcome Measure Information:
Title
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Time Frame
Day 0 up to 70 days post first vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult males or females, 18 - 55 years in good general health
Exclusion Criteria:
Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis N Morrison, D.O.
Organizational Affiliation
Bio-Kinetic Clinical Applications, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
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