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

Sanofi

Status and phase: Terminated; Phase 1

Conditions: Clostridium Difficile Diarrhea; Clostridium Difficile Infection

Treatments: Biological: Vaccine diluent buffer; Biological: Clostridium difficile toxoid vaccine (100 μg); Biological: Clostridium difficile toxoid vaccine (50 μg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772954

H-030-010

Details and patient eligibility

About

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.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

Placebo vaccine group

Placebo Comparator group

Description:

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

Treatment:

Biological: Vaccine diluent buffer

Clostridium Difficile Vaccine Group 1

Experimental group

Description:

Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

Treatment:

Biological: Clostridium difficile toxoid vaccine (50 μg)

Clostridium Difficile Vaccine Group 2

Experimental group

Description:

Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively.

Treatment:

Biological: Clostridium difficile toxoid vaccine (100 μg)