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)
Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2006
Actual (reported)Study Completion
March 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
August 5, 2005
Actual (reported)August 9, 2005
Actual (reported)January 2006
Actual (reported)March 2006
Actual (reported)May 21, 2012
Actual (reported)Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.
Day 0 and up to 7 days post each vaccination
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Day 0 to up to 70 days post-first vaccination
Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Days 28, 56, 70, and 236 Post First Vaccination
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively.
Participants will receive a 2 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively.
Participants will receive a 10 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Greenberg RN, Marbury TC, Foglia G, Warny M. Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine. Vaccine. 2012 Mar 16;30(13):2245-9. doi: 10.1016/j.vaccine.2012.01.065. Epub 2012 Feb 2.
Thomas Marbury, MD
Orlando Clinical Research Center
Richard Greenberg, MD
University of Kentucky
50 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2005
First Posted
August 9, 2005
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
Participants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2006
Actual (reported)Study Completion
March 2006
Actual (reported)Last Updated
September 14, 2012
Results First Posted
May 21, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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