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Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

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ClinicalTrials.gov Identifier: NCT00772954
Recruitment Status : Terminated (Issues with CTM stability.)
First Posted : October 15, 2008
Results First Posted : May 21, 2012
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Clostridium Difficile Diarrhea Biological: Vaccine diluent buffer Biological: Clostridium difficile toxoid vaccine (50 μg) Biological: Clostridium difficile toxoid vaccine (100 μg) Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo vaccine group
Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Vaccine diluent buffer
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Experimental: Clostridium Difficile Vaccine Group 1
Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Clostridium difficile toxoid vaccine (50 μg)
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Experimental: Clostridium Difficile Vaccine Group 2
Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.
Biological: Clostridium difficile toxoid vaccine (100 μg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772954


Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Dennis N Morrison, D.O. Bio-Kinetic Clinical Applications, Inc.

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00772954     History of Changes
Other Study ID Numbers: H-030-010
First Posted: October 15, 2008    Key Record Dates
Results First Posted: May 21, 2012
Last Update Posted: May 21, 2012
Last Verified: April 2012

Keywords provided by Sanofi:
Clostridium difficile diarrhea
Clostridium difficile toxoid vaccine

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vaccines
Immunologic Factors
Physiological Effects of Drugs