- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00127803
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
September 7, 2012 updated by: Sanofi
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively.
|
0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.
|
EXPERIMENTAL: Low dose vaccine
Participants will receive a 2 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.
|
EXPERIMENTAL: Medium dose vaccine
Participants will receive a 10 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.
|
EXPERIMENTAL: High dose vaccine
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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.
Time Frame: Day 0 to up to 70 days post-first vaccination
|
Day 0 to up to 70 days post-first vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Days 28, 56, 70, and 236 Post First Vaccination
|
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). |
Days 28, 56, 70, and 236 Post First Vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (ACTUAL)
January 1, 2006
Study Completion (ACTUAL)
March 1, 2006
Study Registration Dates
First Submitted
August 5, 2005
First Submitted That Met QC Criteria
August 5, 2005
First Posted (ESTIMATE)
August 9, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 14, 2012
Last Update Submitted That Met QC Criteria
September 7, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-030-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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