Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
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ClinicalTrials.gov Identifier: NCT00127803 |
Recruitment Status :
Completed
First Posted : August 9, 2005
Results First Posted : May 21, 2012
Last Update Posted : September 14, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Infections | Biological: Placebo (vaccine diluent) Biological: Clostridium difficile vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
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 Start Date : | July 2005 |
Actual Primary Completion Date : | January 2006 |
Actual Study Completion Date : | March 2006 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28, and 56, respectively.
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Biological: Placebo (vaccine diluent)
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.
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Biological: Clostridium difficile vaccine
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
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Biological: Clostridium difficile vaccine
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
|
Biological: Clostridium difficile vaccine
0.5 mL, intramuscular on Days 0, 28, and 56, respectively. |
- 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 ]
- 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 ]
- 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).

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127803
Principal Investigator: | Thomas Marbury, MD | Orlando Clinical Research Center | |
Principal Investigator: | Richard Greenberg, MD | University of Kentucky |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00127803 |
Other Study ID Numbers: |
H-030-008 |
First Posted: | August 9, 2005 Key Record Dates |
Results First Posted: | May 21, 2012 |
Last Update Posted: | September 14, 2012 |
Last Verified: | September 2012 |
Clostridium difficile |
Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Vaccines Immunologic Factors Physiological Effects of Drugs |