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

Phase 2

Completed

• Conditions: Diarrhea; Clostridium Difficile Infection
• Interventions: Biological: 0.9% Normal Saline; Biological: Clostridium difficile toxoid vaccine; Biological: Clostridium difficile toxoid vaccine with adjuvant

• Registration Number: NCT00772343
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Study Start: 2009-02
• Primary Completion: 2011-07
• Study Completion: 2012-06
• Disposition First Submitted: 2012-06-28
• Disposition First Submitted QC: 2012-06-28
• Disposition First Posted: 2012-07-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo Vaccine	0.9% Normal Saline	0.9% Normal saline
Low dose	Clostridium difficile toxoid vaccine	Low dose vaccine with adjuvant
High dose 1	Clostridium difficile toxoid vaccine with adjuvant	High-dose vaccine with adjuvant
High dose 2	Clostridium difficile toxoid vaccine	High-dose vaccine without adjuvant

Primary Outcome Measures

Name	Time	Method
Recurrence of Clostridium difficile infection.	Approximately 13 weeks after last injection

Secondary Outcome Measures

Name	Time	Method
Safety and immunogenicity	Approximately 13 weeks after last injection.

Trial Locations

Locations (26)

Royal Oldham Hospital; 🇬🇧 Manchester, United Kingdom

St. Richard's Hospital; 🇬🇧 Chichester, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, United Kingdom

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

St Helier Hospital; 🇬🇧 Carshalton, United Kingdom

Cheltenham Royal Hosptial; 🇬🇧 Cheltenham, United Kingdom

St Mary's Hospital; 🇬🇧 Portsmouth, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Frenchay Hospital; 🇬🇧 Bristol, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

New University Hospital (Walsgrave site); 🇬🇧 Coventry, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

Gloucestersh Royal Hospital; 🇬🇧 Gloucester, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

West Park Hospital; 🇬🇧 Epsom, United Kingdom

Whittington Hospital; 🇬🇧 London, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, United Kingdom

North Manchester General Hospital; 🇬🇧 Manchester, United Kingdom

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom

Northern General Hospital; 🇬🇧 Sheffield, United Kingdom

Stepping Hill Hospital; 🇬🇧 Stockport, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Sunderland Royal Hospital; 🇬🇧 Sunderland, United Kingdom

St. George's Hospital; 🇬🇧 Tooting, London, United Kingdom

Worthing General Hospital; 🇬🇧 Worthing, United Kingdom