Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00772343
First received: October 10, 2008
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diarrhea Clostridium Difficile Infection |
Biological: 0.9% Normal Saline Biological: Clostridium difficile toxoid vaccine Biological: Clostridium difficile toxoid vaccine with adjuvant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, 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) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Recurrence of Clostridium difficile infection. [ Time Frame: Approximately 13 weeks after last injection ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety and immunogenicity [ Time Frame: Approximately 13 weeks after last injection. ] [ Designated as safety issue: Yes ]
| Enrollment: | 116 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Vaccine
0.9% Normal saline
|
Biological: 0.9% Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: Normal Saline
|
|
Experimental: Low dose
Low dose vaccine with adjuvant
|
Biological: Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: ACAM-CDIFF™
|
|
Experimental: High dose 1
High-dose vaccine with adjuvant
|
Biological: Clostridium difficile toxoid vaccine with adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
Other Names:
|
|
Experimental: High dose 2
High-dose vaccine without adjuvant
|
Biological: Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Other Name: ACAM-CDIFF™
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772343
Locations
| United States, Florida | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Marietta, Georgia, United States, 33360 | |
| United States, Massachusetts | |
| Worcester, Massachusetts, United States, 01608 | |
| United States, Montana | |
| Butte, Montana, United States, 59701 | |
| United States, South Dakota | |
| Rapid City, South Dakota, United States, 57701 | |
| United Kingdom | |
| Birmingham Heartlands Hospital | |
| Birmingham, United Kingdom, B9 5SS | |
| Blackpool Victoria Hospital | |
| Blackpool, United Kingdom, FY3 8NR | |
| Bradford Royal Infirmary | |
| Bradford, United Kingdom, BD9 6RJ | |
| Royal Sussex County Hospital | |
| Brighton, United Kingdom, BN2 5BE | |
| Southmead Hospital | |
| Bristol, United Kingdom, BS16 1LE | |
| Frenchay Hospital | |
| Bristol, United Kingdom, BS16 iLE | |
| St Helier Hospital | |
| Carshalton, United Kingdom, KT19 8PB | |
| Cheltenham Royal Hosptial | |
| Cheltenham, United Kingdom, GL53 7AN | |
| St. Richard's Hospital | |
| Chichester, United Kingdom, PO19 6SE | |
| New University Hospital (Walsgrave site) | |
| Coventry, United Kingdom, CV2 2DX | |
| Ninewells Hospital | |
| Dundee, United Kingdom, DD1 9SY | |
| West Park Hospital | |
| Epsom, United Kingdom, KT19 8PB | |
| Gloucestersh Royal Hospital | |
| Gloucester, United Kingdom, GL1 3NN | |
| Leeds General Infirmary | |
| Leeds, United Kingdom, LS1 3EX | |
| Leicester Royal Infirmary | |
| Leicester, United Kingdom, LE1 5WW | |
| Whittington Hospital | |
| London, United Kingdom, N19 5NF | |
| North Manchester General Hospital | |
| Manchester, United Kingdom, M8 5RB | |
| Royal Oldham Hospital | |
| Manchester, United Kingdom, M8 5RB | |
| Queen Alexandra Hospital | |
| Portsmouth, United Kingdom, PO6 3LY | |
| St Mary's Hospital | |
| Portsmouth, United Kingdom, PO3 6AD | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom, S1 2RX | |
| Northern General Hospital | |
| Sheffield, United Kingdom, S1 2RX | |
| Stepping Hill Hospital | |
| Stockport, United Kingdom, SK2 7JE | |
| Sunderland Royal Hospital | |
| Sunderland, United Kingdom, SR4 7TP | |
| St. George's Hospital | |
| Tooting, London, United Kingdom, SW17 0RE | |
| Worthing General Hospital | |
| Worthing, United Kingdom, BN11 2DH | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00772343 History of Changes |
| Other Study ID Numbers: | H-030-011, 2008-004907-69, 28439/0001/001 |
| Study First Received: | October 10, 2008 |
| Last Updated: | June 28, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Diarrhea Clostridium difficile infection Clostridium difficile toxoid |
Additional relevant MeSH terms:
|
Diarrhea Clostridium Infections Signs and Symptoms, Digestive Signs and Symptoms Gram-Positive Bacterial Infections |
Bacterial Infections Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013