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)
1 other identifier
interventional
48
1 country
2
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 elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
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 Nov 2005
Shorter than P25 for phase_1
2 active sites
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
First Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedResults Posted
Study results publicly available
April 9, 2012
CompletedApril 11, 2012
April 1, 2012
3 months
September 16, 2005
March 13, 2012
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Day up to Day 236 post first vaccination
Study Arms (4)
Placebo Vaccine Group
PLACEBO COMPARATORParticipants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
Low Dose Vaccine Group
EXPERIMENTALParticipants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Medium dose vaccine group
EXPERIMENTALParticipants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
High dose vaccine group
EXPERIMENTALParticipants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Interventions
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Eligibility Criteria
You may qualify if:
- Adult males or females, \> or = 65 years
- In good general health
- Clinical lab tests within normal range
- Females must be post-menopausal
- 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
- 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
Study Sites (2)
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas P 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
November 1, 2005
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
April 11, 2012
Results First Posted
April 9, 2012
Record last verified: 2012-04