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

September 6, 2013 updated by: Sanofi Pasteur, a Sanofi Company

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Brighton, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Bristol, United Kingdom, BS16 1LE
        • Southmead Hospital
      • Bristol, United Kingdom, BS16 iLE
        • Frenchay Hospital
      • Carshalton, United Kingdom, KT19 8PB
        • St Helier Hospital
      • Cheltenham, United Kingdom, GL53 7AN
        • Cheltenham Royal Hosptial
      • Chichester, United Kingdom, PO19 6SE
        • St. Richard's Hospital
      • Coventry, United Kingdom, CV2 2DX
        • New University Hospital (Walsgrave site)
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Epsom, United Kingdom, KT19 8PB
        • West Park Hospital
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestersh Royal Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, N19 5NF
        • Whittington Hospital
      • Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital
      • Manchester, United Kingdom, M8 5RB
        • Royal Oldham Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Portsmouth, United Kingdom, PO3 6AD
        • St Mary's Hospital
      • Sheffield, United Kingdom, S1 2RX
        • Northern General Hospital
      • Sheffield, United Kingdom, S1 2RX
        • Royal Hallamshire Hospital
      • Stockport, United Kingdom, SK2 7JE
        • Stepping Hill Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Tooting, London, United Kingdom, SW17 0RE
        • St. George's Hospital
      • Worthing, United Kingdom, BN11 2DH
        • Worthing General Hospital
  • United States
    • Florida
      • Tampa, Florida, United States, 33614
    • Georgia
      • Marietta, Georgia, United States, 33360
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
    • Montana
      • Butte, Montana, United States, 59701
    • South Dakota
      • Rapid City, South Dakota, United States, 57701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • ACAM-CDIFF™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of Clostridium difficile infection.
Time Frame: Approximately 13 weeks after last injection
Approximately 13 weeks after last injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and immunogenicity
Time Frame: Approximately 13 weeks after last injection.
Approximately 13 weeks after last injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (ESTIMATE)

October 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-030-011
  • 2008-004907-69 (EUDRACT_NUMBER)
  • 28439/0001/001 (OTHER: MHRA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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