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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00127803

Purpose

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.

Condition	Intervention	Phase
Clostridium Infections	Biological: Placebo Biological: Modified Clostridium difficile vaccine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	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)

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	July 2005
Study Completion Date:	March 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Biological: Placebo
Experimental: Low dose vaccine	Biological: Modified Clostridium difficile vaccine
Experimental: Medium dose vaccine	Biological: Modified Clostridium difficile vaccine
Experimental: High dose vaccine	Biological: Modified Clostridium difficile vaccine

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Adult males or females, 18-55 years (inclusive)
In good general health
Clinical lab tests within normal range
Non-pregnant female subjects
Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine

Exclusion Criteria:

Evidence of C. difficile infection
Evidence of any previous antibiotic-associated diarrhea
Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
History of malignancy within 5 years
History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
Known or suspected history of immunodeficiency;
Active or inactive immune-mediated or inflammatory disease;
Pregnant or lactating female subjects;
History of drug or alcohol abuse disorders;
Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
Receipt of antibiotic therapy or an investigational drug within prior 30 days
Blood or organ donation within prior 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127803

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Thomas Marbury, MD	Orlando Clinical Research Center
Principal Investigator:	Richard Greenberg, MD	University of Kentucky

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Program Manager, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00127803 History of Changes
Other Study ID Numbers:	H-030-008
Study First Received:	August 5, 2005
Last Updated:	June 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Clostridium difficile

Additional relevant MeSH terms:

Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012