Clinical trial NCT00772343: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
Clostridium Difficile Infection
Keywords: Diarrhea
Clostridium difficile infection
Clostridium difficile toxoid
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Recurrence of Clostridium difficile infection.
timeFrame: Approximately 13 weeks after last injection
Secondary outcomes:
measure: Safety and immunogenicity
timeFrame: Approximately 13 weeks after last injection.
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Worcester
country: United States
state: Massachusetts
city: Butte
country: United States
state: Montana
city: Rapid City
country: United States
state: South Dakota
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Carshalton
country: United Kingdom
facility: St Helier Hospital
city: Cheltenham
country: United Kingdom
facility: Cheltenham Royal Hosptial
city: Chichester
country: United Kingdom
facility: St. Richard's Hospital
city: Coventry
country: United Kingdom
facility: New University Hospital (Walsgrave site)
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Epsom
country: United Kingdom
facility: West Park Hospital
city: Gloucester
country: United Kingdom
facility: Gloucestersh Royal Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Whittington Hospital
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Manchester
country: United Kingdom
facility: Royal Oldham Hospital
city: Portsmouth
country: United Kingdom
facility: St Mary's Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Tooting, London
country: United Kingdom
facility: St. George's Hospital
city: Worthing
country: United Kingdom
facility: Worthing General Hospital
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: