NCT00214461

Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly 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 Elderly Volunteers (> or =65 Years)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 65 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 elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.

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	Vaccine diluent buffer (Placebo)	0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
BIOLOGICAL	C. difficile toxoid vaccine (2 µg)	0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
BIOLOGICAL	C. difficile toxoid vaccine (10 µg)	0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
BIOLOGICAL	C. difficile toxoid vaccine (50 µg)	0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2005-09-22
• Last updated: 2012-04-11
• Results posted: 2012-04-09

Locations

2 sites across 1 country: United States