Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
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ClinicalTrials.gov Identifier: NCT00214461 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : April 9, 2012
Last Update Posted : April 11, 2012
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Condition or disease | Intervention/treatment | Phase |
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Clostridium Infections | Biological: Vaccine diluent buffer (Placebo) Biological: C. difficile toxoid vaccine (2 µg) Biological: C. difficile toxoid vaccine (10 µg) Biological: C. difficile toxoid vaccine (50 µg) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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 Elderly Volunteers (> or =65 Years) |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo Vaccine Group
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
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Biological: Vaccine diluent buffer (Placebo)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
Experimental: Low Dose Vaccine Group
Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
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Biological: C. difficile toxoid vaccine (2 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
Experimental: Medium dose vaccine group
Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
|
Biological: C. difficile toxoid vaccine (10 µg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively. |
Experimental: High dose vaccine group
Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
|
Biological: C. difficile toxoid vaccine (50 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. |
- 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 Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine. [ Time Frame: Day up to Day 236 post first vaccination ]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).

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT00214461
United States, Florida | |
Orlando Clinical Research Center | |
Orlando, Florida, United States, 32809 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 |
Principal Investigator: | Thomas P Marbury, MD | Orlando Clinical Research Center | |
Principal Investigator: | Richard Greenberg, MD | University of Kentucky |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00214461 |
Other Study ID Numbers: |
H-030-009 |
First Posted: | September 22, 2005 Key Record Dates |
Results First Posted: | April 9, 2012 |
Last Update Posted: | April 11, 2012 |
Last Verified: | April 2012 |
Clostridium difficile |
Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Vaccines Immunologic Factors Physiological Effects of Drugs |