NCT00127803

Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers

A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Study of the Safety, Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18-55 Years)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years of age.

Detailed description

Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.

Conditions

• Clostridium Infections

Interventions

Type	Name	Description
BIOLOGICAL	Placebo (vaccine diluent)	0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
BIOLOGICAL	Clostridium difficile vaccine	0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
BIOLOGICAL	Clostridium difficile vaccine	0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
BIOLOGICAL	Clostridium difficile vaccine	0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-01-01
• Completion: 2006-03-01
• First posted: 2005-08-09
• Last updated: 2012-09-14
• Results posted: 2012-05-21