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Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT00772343
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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

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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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:
  • ACAM-CDIFF™
  • ACAM-CDIFF™ Adjuvant
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™


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence of Clostridium difficile infection. [ Time Frame: Approximately 13 weeks after last injection ]

Secondary Outcome Measures :
  1. Safety and immunogenicity [ Time Frame: Approximately 13 weeks after last injection. ]

Eligibility Criteria
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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:

  1. Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
  2. Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
  3. Subjects who are medically stable.
  4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.

Exclusion Criteria:

  1. Subjects who are currently on treatment for a recurrence of CDI.
  2. Subjects who are currently or have recently been treated with immunoglobulin therapy.
  3. Pregnant or breast feeding females.
  4. Concurrent, acutely life-threatening diseases.
Contacts and Locations
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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
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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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 ):
Diarrhea
Clostridium difficile infection
Clostridium difficile toxoid
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Diarrhea
Signs and Symptoms, Digestive
Gram-Positive Bacterial Infections
Bacterial Infections
 Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs