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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00772343
First received: October 10, 2008
Last updated: September 6, 2013
Last verified: September 2013
  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:
  • 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™

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Frenchay Hospital
Bristol, United Kingdom, BS16 iLE
Southmead Hospital
Bristol, United Kingdom, BS16 1LE
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
St Mary's Hospital
Portsmouth, United Kingdom, PO3 6AD
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
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 Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
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: September 6, 2013
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:
Communicable Diseases
Diarrhea
Infection
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014