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)
1 other identifier
interventional
50
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2005
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 5, 2005
CompletedFirst Posted
Study publicly available on registry
August 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedResults Posted
Study results publicly available
May 21, 2012
CompletedSeptember 14, 2012
September 1, 2012
6 months
August 5, 2005
March 13, 2012
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
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
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively.
Low dose vaccine
EXPERIMENTALParticipants will receive a 2 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively.
Medium dose vaccine
EXPERIMENTALParticipants will receive a 10 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
High dose vaccine
EXPERIMENTALParticipants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
Interventions
0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Related Publications (1)
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.
PMID: 22306375DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Marbury, MD
Orlando Clinical Research Center
- PRINCIPAL INVESTIGATOR
Richard Greenberg, MD
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2005
First Posted
August 9, 2005
Study Start
July 1, 2005
Primary Completion
January 1, 2006
Study Completion
March 1, 2006
Last Updated
September 14, 2012
Results First Posted
May 21, 2012
Record last verified: 2012-09