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

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

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.

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Sanofi

Investigators

• Principal Investigator: Dennis N Morrison, D.O.; Bio-Kinetic Clinical Applications, Inc.

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00772954
• Other Study ID Numbers: H-030-010
• First Posted: October 15, 2008
• 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:

Clostridium Infections; Diarrhea; Signs and Symptoms, Digestive; Gram-Positive Bacterial Infections; Bacterial Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs