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

NCT ID: NCT00772954

Last Updated: 2012-05-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-06-30

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).

Conditions

Clostridium Difficile Infection; Clostridium Difficile Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo vaccine group

Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively.

Group Type: PLACEBO_COMPARATOR

Vaccine diluent buffer

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

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.

Group Type: EXPERIMENTAL

Clostridium difficile toxoid vaccine (50 μg)

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

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.

Group Type: EXPERIMENTAL

Clostridium difficile toxoid vaccine (100 μg)

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Interventions

Vaccine diluent buffer

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

Intervention Type: BIOLOGICAL

Clostridium difficile toxoid vaccine (50 μg)

0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.

Intervention Type: BIOLOGICAL

Clostridium difficile toxoid vaccine (100 μg)

0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis N Morrison, D.O.

Role: PRINCIPAL_INVESTIGATOR

Bio-Kinetic Clinical Applications, Inc.

Other Identifiers

H-030-010

Identifier Type: -

Identifier Source: org_study_id