DiarrheaPhase 2NCT00772343
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
A Phase 2 study testing 0.9% Normal Saline, Clostridium difficile toxoid vaccine and Clostridium difficile toxoid vaccine with adjuvant in people with Diarrhea and Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 31 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diarrhea, Clostridium Difficile Infection
- What is being tested?
- 0.9% Normal Saline, Clostridium difficile toxoid vaccine and Clostridium difficile toxoid vaccine with adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Feb 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United Kingdom26 sites
Birmingham Heartlands Hospital
Birmingham, B9 5SS
Blackpool Victoria Hospital
Blackpool, FY3 8NR
Bradford Royal Infirmary
Bradford, BD9 6RJ
Royal Sussex County Hospital
Brighton, BN2 5BE
Southmead Hospital
Bristol, BS16 1LE
Frenchay Hospital
Bristol, BS16 iLE
St Helier Hospital
Carshalton, KT19 8PB
Cheltenham Royal Hosptial
Cheltenham, GL53 7AN
St. Richard's Hospital
Chichester, PO19 6SE
New University Hospital (Walsgrave site)
Coventry, CV2 2DX
Ninewells Hospital
Dundee, DD1 9SY
West Park Hospital
Epsom, KT19 8PB
Gloucestersh Royal Hospital
Gloucester, GL1 3NN
Leeds General Infirmary
Leeds, LS1 3EX
Leicester Royal Infirmary
Leicester, LE1 5WW
Whittington Hospital
London, N19 5NF
North Manchester General Hospital
Manchester, M8 5RB
Royal Oldham Hospital
Manchester, M8 5RB
St Mary's Hospital
Portsmouth, PO3 6AD
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Northern General Hospital
Sheffield, S1 2RX
Royal Hallamshire Hospital
Sheffield, S1 2RX
Stepping Hill Hospital
Stockport, SK2 7JE
Sunderland Royal Hospital
Sunderland, SR4 7TP
St. George's Hospital
Tooting, London, SW17 0RE
Worthing General Hospital
Worthing, BN11 2DH
United States5 sites
Study site
Butte, Montana, 59701
Study site
Marietta, Georgia, 33360
Study site
Rapid City, South Dakota, 57701
Study site
Tampa, Florida, 33614
Study site
Worcester, Massachusetts, 01608
About this study
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)
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.
Read the 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.
- Conditions
- Diarrhea, Clostridium Difficile Infection
- Being tested
- 0.9% Normal Saline, Clostridium difficile toxoid vaccine, Clostridium difficile toxoid vaccine with adjuvant
- Keywords
- Diarrhea, Clostridium difficile infection, Clostridium difficile toxoid
- Medical subject headings
- Diarrhea, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Normal SalineBiological
Also called Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccineBiological
Also called ACAM-CDIFF™
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccine with adjuvantBiological
Also called ACAM-CDIFF™, ACAM-CDIFF™ Adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccineBiological
Also called ACAM-CDIFF™
0.5 mL, intramuscular on Days 0, 7, and 28
| Study group | Role | What they receive |
|---|---|---|
| Placebo Vaccine | Placebo comparator | 0.9% Normal saline Receives: Biological: 0.9% Normal Saline |
| Low dose | Experimental | Low dose vaccine with adjuvant Receives: Biological: Clostridium difficile toxoid vaccine |
| High dose 1 | Experimental | High-dose vaccine with adjuvant Receives: Biological: Clostridium difficile toxoid vaccine with adjuvant |
| High dose 2 | Experimental | High-dose vaccine without adjuvant Receives: Biological: Clostridium difficile toxoid vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Clostridium difficile infection.
Measured: Approximately 13 weeks after last injection
Secondary outcomes (1)
Safety and immunogenicity
Measured: Approximately 13 weeks after last injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772343
- Sponsor's protocol ID
- H-030-011
- Other IDs
- 2008-004907-69, 28439/0001/001, 2008
- Status last verified
- Sep 2013
- First submitted
- 10 Oct 2008
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00772343
- Acronym / sponsor ID
- H-030-011
- Conditions
- Diarrhea, Clostridium Difficile Infection
- Keywords
- Diarrhea, Clostridium difficile infection, Clostridium difficile toxoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Vaccine | Placebo comparator | Biological: 0.9% Normal Saline0.9% Normal saline |
| Low dose | Experimental | Biological: Clostridium difficile toxoid vaccineLow dose vaccine with adjuvant |
| High dose 1 | Experimental | Biological: Clostridium difficile toxoid vaccine with adjuvantHigh-dose vaccine with adjuvant |
| High dose 2 | Experimental | Biological: Clostridium difficile toxoid vaccineHigh-dose vaccine without adjuvant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% Normal SalineAlso: Normal Saline0.5 mL, intramuscular on Days 0, 7, and 28 | Biological | Placebo Vaccine |
| Clostridium difficile toxoid vaccineAlso: ACAM-CDIFF™0.5 mL, intramuscular on Days 0, 7, and 28 | Biological | Low dose |
| Clostridium difficile toxoid vaccine with adjuvantAlso: ACAM-CDIFF™, ACAM-CDIFF™ Adjuvant0.5 mL, intramuscular on Days 0, 7, and 28 | Biological | High dose 1 |
| Clostridium difficile toxoid vaccineAlso: ACAM-CDIFF™0.5 mL, intramuscular on Days 0, 7, and 28 | Biological | High dose 2 |
Primary outcome
Recurrence of Clostridium difficile infection.
Time frame: Approximately 13 weeks after last injection
1 secondary outcome
Safety and immunogenicity
Time frame: Approximately 13 weeks after last injection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Sanofi Pasteur Inc.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.9% Normal Saline, Clostridium difficile toxoid vaccine and Clostridium difficile toxoid vaccine with adjuvant in people with Diarrhea and Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Clostridium difficile infection. (time frame: Approximately 13 weeks after last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.