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

Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772343
• Other study ID #: H-030-011
• Secondary ID: 2008-004907-6928
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2008
• Last updated: September 6, 2013
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Communicable Diseases
• Diarrhea
• Infection

Intervention

Biological:
• 0.9% Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
• Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
• Clostridium difficile toxoid vaccine with adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
• Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Frenchay Hospital	Bristol
United Kingdom	Southmead Hospital	Bristol
United Kingdom	St Helier Hospital	Carshalton
United Kingdom	Cheltenham Royal Hosptial	Cheltenham
United Kingdom	St. Richard's Hospital	Chichester
United Kingdom	New University Hospital (Walsgrave site)	Coventry
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	West Park Hospital	Epsom
United Kingdom	Gloucestersh Royal Hospital	Gloucester
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Whittington Hospital	London
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Royal Oldham Hospital	Manchester
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	St Mary's Hospital	Portsmouth
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	Stepping Hill Hospital	Stockport
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	St. George's Hospital	Tooting, London
United Kingdom	Worthing General Hospital	Worthing

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Clostridium difficile infection.		Approximately 13 weeks after last injection	Yes
Secondary	Safety and immunogenicity		Approximately 13 weeks after last injection.	Yes

External Links

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