Trial record 1 of 1 for:
H-030-011
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
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| ClinicalTrials.gov Identifier: NCT00772343 |
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Recruitment Status :
Completed
First Posted : October 15, 2008
Last Update Posted : September 17, 2013
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Brief Summary:
Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care.
Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diarrhea Clostridium Difficile Infection | Biological: 0.9% Normal Saline Biological: Clostridium difficile toxoid vaccine Biological: Clostridium difficile toxoid vaccine with adjuvant | Phase 2 |
This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their first event of CDI and are being treated with the antibiotic standard of care. This study will be conducted in the United States and United Kingdom. Adult subjects with limited chronic disease, who are currently receiving treatment for their first episode of CDI will be enrolled in this trial. Subjects will be required to be able to take oral antibiotics.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of A Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection (CDI) |
| Study Start Date : | February 2009 |
| Actual Primary Completion Date : | July 2011 |
| Actual Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo Vaccine
0.9% Normal saline
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Biological: 0.9% Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: Normal Saline |
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Experimental: Low dose
Low dose vaccine with adjuvant
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Biological: Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: ACAM-CDIFF™ |
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Experimental: High dose 1
High-dose vaccine with adjuvant
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Biological: Clostridium difficile toxoid vaccine with adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
Other Names:
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Experimental: High dose 2
High-dose vaccine without adjuvant
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Biological: Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: ACAM-CDIFF™ |
Primary Outcome Measures :
- Recurrence of Clostridium difficile infection. [ Time Frame: Approximately 13 weeks after last injection ]
Secondary Outcome Measures :
- Safety and immunogenicity [ Time Frame: Approximately 13 weeks after last injection. ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
- Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
- Subjects who are medically stable.
- Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
Exclusion Criteria:
- Subjects who are currently on treatment for a recurrence of CDI.
- Subjects who are currently or have recently been treated with immunoglobulin therapy.
- Pregnant or breast feeding females.
- Concurrent, acutely life-threatening diseases.
Information from the National Library of Medicine
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): NCT00772343
Locations
Show 31 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00772343 |
| Other Study ID Numbers: |
H-030-011 2008-004907-69 ( EudraCT Number ) 28439/0001/001 ( Other Identifier: MHRA ) |
| First Posted: | October 15, 2008 Key Record Dates |
| Last Update Posted: | September 17, 2013 |
| Last Verified: | September 2013 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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Diarrhea Clostridium difficile infection Clostridium difficile toxoid |
Additional relevant MeSH terms:
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Infections Communicable Diseases Clostridium Infections Diarrhea Disease Attributes Pathologic Processes Signs and Symptoms, Digestive |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Vaccines Immunologic Factors Physiological Effects of Drugs |