Back to resultsSafety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Primary Purpose
Clostridium Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo (vaccine diluent)
Clostridium difficile vaccine
Clostridium difficile vaccine
Clostridium difficile vaccine
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, 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Low dose vaccine
Medium dose vaccine
High dose vaccine
Arm Description
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
Participants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
Outcomes
Primary Outcome Measures
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.
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 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.
Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.
Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00127803
Brief Title
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult 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 Adult Volunteers (18-55 Years)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 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 adults aged 18-55 years of age.
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 ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
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
Arm Type
Experimental
Arm Description
Participants will receive a 2 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively.
Arm Title
Medium dose vaccine
Arm Type
Experimental
Arm Description
Participants will receive a 10 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
Arm Title
High dose vaccine
Arm Type
Experimental
Arm Description
Participants will receive a 50 μg dose of C. difficile toxoid vaccine on Days 0, 28, and 56, respectively
Intervention Type
Biological
Intervention Name(s)
Placebo (vaccine diluent)
Intervention Description
0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile vaccine
Intervention Description
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile vaccine
Intervention Description
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile vaccine
Intervention Description
0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Primary Outcome Measure Information:
Title
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.
Time Frame
Day 0 and up to 7 days post each vaccination
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 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.
Description
Seroconversion was defined as a ≥4-fold increase in antibody levels from Baseline. For values below the limit of quantification (LLQ) for the assay, the LLQ was used.
Serum anti-toxin IgG levels were determined by enzyme linked immunosorbent assay (ELISA).
Time Frame
Days 28, 56, 70, and 236 Post First Vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas 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
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
Links:
URL
http://www.sanofipasteur.com/
Description
Related Info
Learn more about this trial
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
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