Back to resultsSafety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Primary Purpose
Clostridium Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vaccine diluent buffer (Placebo)
C. difficile toxoid vaccine (2 µg)
C. difficile toxoid vaccine (10 µg)
C. difficile toxoid vaccine (50 µg)
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Infections focused on measuring Clostridium difficile
Eligibility Criteria
Inclusion Criteria: 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 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 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.
Sites / Locations
- Orlando Clinical Research Center
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo Vaccine Group
Low Dose Vaccine Group
Medium dose vaccine group
High dose vaccine group
Arm Description
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject's specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00214461
Brief Title
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
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 Elderly Volunteers (> or =65 Years)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Infections
Keywords
Clostridium difficile
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Vaccine Group
Arm Type
Placebo Comparator
Arm Description
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
Arm Title
Low Dose Vaccine Group
Arm Type
Experimental
Arm Description
Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Arm Title
Medium dose vaccine group
Arm Type
Experimental
Arm Description
Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Arm Title
High dose vaccine group
Arm Type
Experimental
Arm Description
Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Vaccine diluent buffer (Placebo)
Intervention Description
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
C. difficile toxoid vaccine (2 µg)
Intervention Description
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
C. difficile toxoid vaccine (10 µg)
Intervention Description
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
Intervention Type
Biological
Intervention Name(s)
C. difficile toxoid vaccine (50 µg)
Intervention Description
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Primary Outcome Measure Information:
Title
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.
Time Frame
Day 0 to up to 70 days post first vaccination
Secondary Outcome Measure Information:
Title
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.
Description
Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject's specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).
Time Frame
Day up to Day 236 post first vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas P Marbury, MD
Organizational Affiliation
Orlando Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Greenberg, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22306375
Citation
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.
Results Reference
derived
Learn more about this trial
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
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