NCT01230957

Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults

Safety and Immunogenicity of Different Formulations of a Clostridium Difficile Toxoid Vaccine Administered at Three Different Schedules in Adults Aged 40 to 75 Years at Risk of C. Difficile Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility. Primary Objectives: * To describe the safety profile of subjects in each of the study groups. * To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups. Observational Objective: * To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.

Detailed description

Participants will receive 3 doses of either one of 4 different formulations of ACAM-CDIFF™ vaccine or placebo, on one of 3 different schedules. The trial will have 2 stages. Stage I will test 4 different formulations of ACAM-CDIFF™ vaccine. Stage II will explore different vaccination schedules using one of these formulations. Participants will be followed up for safety and immunogenicity; stool samples will also be provided in case of diarrhea.

Conditions

• Clostridium Difficile Infection
• Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	Clostridium difficile toxoids A and B (Low-dose with adjuvant)	0.5 mL, Intramuscular on Days 0, 7, and 30
BIOLOGICAL	Clostridium difficile toxoids A and B (Low-dose without adjuvant)	0.5 mL, Intramuscular on Days 0, 7, and 30
BIOLOGICAL	Clostridium difficile toxoids A and B (high-dose with adjuvant)	0.5 mL, Intramuscular on Days 0, 7, and 30
BIOLOGICAL	Clostridium difficile toxoids A and B (high-dose without adjuvant)	0.5 mL, Intramuscular on Days 0, 7, and 30
BIOLOGICAL	Placebo: 0.9% normal saline	0.5 mL, Intramuscular on Days 0, 7, and 30
BIOLOGICAL	Clostridium difficile toxoids A and B (high-dose with adjuvant)	0.5 mL, Intramuscular on Days 0, 7, and 180
BIOLOGICAL	Clostridium difficile toxoids A and B (high-dose with adjuvant)	0.5 mL, Intramuscular on Days 0, 30, and 180

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-11-01
• Completion: 2013-03-01
• First posted: 2010-10-29
• Last updated: 2018-07-18

Locations

30 sites across 1 country: United States