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

Primary Purpose

Diarrhea, Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
0.9% Normal Saline
Clostridium difficile toxoid vaccine
Clostridium difficile toxoid vaccine with adjuvant
Clostridium difficile toxoid vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring Diarrhea, Clostridium difficile infection, Clostridium difficile toxoid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Heartlands Hospital
  • Blackpool Victoria Hospital
  • Bradford Royal Infirmary
  • Royal Sussex County Hospital
  • Southmead Hospital
  • Frenchay Hospital
  • St Helier Hospital
  • Cheltenham Royal Hosptial
  • St. Richard's Hospital
  • New University Hospital (Walsgrave site)
  • Ninewells Hospital
  • West Park Hospital
  • Gloucestersh Royal Hospital
  • Leeds General Infirmary
  • Leicester Royal Infirmary
  • Whittington Hospital
  • North Manchester General Hospital
  • Royal Oldham Hospital
  • St Mary's Hospital
  • Queen Alexandra Hospital
  • Northern General Hospital
  • Royal Hallamshire Hospital
  • Stepping Hill Hospital
  • Sunderland Royal Hospital
  • St. George's Hospital
  • Worthing General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo Vaccine

Low dose

High dose 1

High dose 2

Arm Description

0.9% Normal saline

Low dose vaccine with adjuvant

High-dose vaccine with adjuvant

High-dose vaccine without adjuvant

Outcomes

Primary Outcome Measures

Recurrence of Clostridium difficile infection.

Secondary Outcome Measures

Safety and immunogenicity

Full Information

First Posted
October 10, 2008
Last Updated
September 6, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00772343
Brief Title
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
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 Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Clostridium Difficile Infection
Keywords
Diarrhea, Clostridium difficile infection, Clostridium difficile toxoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Vaccine
Arm Type
Placebo Comparator
Arm Description
0.9% Normal saline
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Low dose vaccine with adjuvant
Arm Title
High dose 1
Arm Type
Experimental
Arm Description
High-dose vaccine with adjuvant
Arm Title
High dose 2
Arm Type
Experimental
Arm Description
High-dose vaccine without adjuvant
Intervention Type
Biological
Intervention Name(s)
0.9% Normal Saline
Other Intervention Name(s)
Normal Saline
Intervention Description
0.5 mL, intramuscular on Days 0, 7, and 28
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile toxoid vaccine
Other Intervention Name(s)
ACAM-CDIFF™
Intervention Description
0.5 mL, intramuscular on Days 0, 7, and 28
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile toxoid vaccine with adjuvant
Other Intervention Name(s)
ACAM-CDIFF™, ACAM-CDIFF™ Adjuvant
Intervention Description
0.5 mL, intramuscular on Days 0, 7, and 28
Intervention Type
Biological
Intervention Name(s)
Clostridium difficile toxoid vaccine
Other Intervention Name(s)
ACAM-CDIFF™
Intervention Description
0.5 mL, intramuscular on Days 0, 7, and 28
Primary Outcome Measure Information:
Title
Recurrence of Clostridium difficile infection.
Time Frame
Approximately 13 weeks after last injection
Secondary Outcome Measure Information:
Title
Safety and immunogenicity
Time Frame
Approximately 13 weeks after last injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
33360
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
ZIP/Postal Code
BS16 iLE
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
ZIP/Postal Code
KT19 8PB
Country
United Kingdom
Facility Name
Cheltenham Royal Hosptial
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
St. Richard's Hospital
City
Chichester
ZIP/Postal Code
PO19 6SE
Country
United Kingdom
Facility Name
New University Hospital (Walsgrave site)
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
West Park Hospital
City
Epsom
ZIP/Postal Code
KT19 8PB
Country
United Kingdom
Facility Name
Gloucestersh Royal Hospital
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Portsmouth
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S1 2RX
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S1 2RX
Country
United Kingdom
Facility Name
Stepping Hill Hospital
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
St. George's Hospital
City
Tooting, London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Worthing General Hospital
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

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

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