Clostridium Difficile InfectionPhase 1NCT00772954
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
A Phase 1 study testing Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg) and Clostridium difficile toxoid vaccine (100 μg) in people with Clostridium Difficile Infection and Clostridium Difficile Diarrhea, run by Sanofi.
Trial summary
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Infection, Clostridium Difficile Diarrhea
- What is being tested?
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg) and Clostridium difficile toxoid vaccine (100 μg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jun 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males or females, 18 - 55 years in good general health
Who cannot join
- Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
- Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
- Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
About this study
Official title: A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
Read the detailed description
This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).
- Being tested
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Keywords
- Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine diluent bufferBiological
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Clostridium difficile toxoid vaccine (50 μg)Biological
0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively.
Clostridium difficile toxoid vaccine (100 μg)Biological
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Placebo vaccine group | Placebo comparator | Participants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively. Receives: Biological: Vaccine diluent buffer |
| Clostridium Difficile Vaccine Group 1 | Experimental | Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. Receives: Biological: Clostridium difficile toxoid vaccine (50 μg) |
| Clostridium Difficile Vaccine Group 2 | Experimental | Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. Receives: Biological: Clostridium difficile toxoid vaccine (100 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Measured: Day 0 up to 70 days post first vaccination
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 startMar 2006
- Primary completionJun 2006
- Study completionJun 2006
Why it stopped: Issues with CTM stability.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis N Morrison, D.O., Principal investigator, Bio-Kinetic Clinical Applications, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772954
- Sponsor's protocol ID
- H-030-010
- Status last verified
- Apr 2012
- First submitted
- 10 Oct 2008
- Last updated
- 21 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)
- ClinicalTrials.gov ID
- NCT00772954
- Acronym / sponsor ID
- H-030-010
- Keywords
- Clostridium difficile diarrhea, Clostridium difficile toxoid vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues with CTM stability.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 21 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
Detailed description
This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo vaccine group | Placebo comparator | Biological: Vaccine diluent bufferParticipants scheduled to receive a dose of placebo vaccine on Day 0, Day 28, and Day 56, respectively. |
| Clostridium Difficile Vaccine Group 1 | Experimental | Biological: Clostridium difficile toxoid vaccine (50 μg)Participants scheduled to receive a dose of 50 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. |
| Clostridium Difficile Vaccine Group 2 | Experimental | Biological: Clostridium difficile toxoid vaccine (100 μg)Participants scheduled to receive a dose of 100 μg Clostridium Difficile vaccine on Day 0, Day 28, and Day 56, respectively. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult males or females, 18 - 55 years in good general health
Key exclusion criteria (3 listed)
- Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
- Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
- Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.
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 |
|---|---|---|
| Vaccine diluent buffer0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively. | Biological | Placebo vaccine group |
| Clostridium difficile toxoid vaccine (50 μg)0.5 mL, Intramuscular at Day 0, Day 28 and Day 56, respectively. | Biological | Clostridium Difficile Vaccine Group 1 |
| Clostridium difficile toxoid vaccine (100 μg)0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively. | Biological | Clostridium Difficile Vaccine Group 2 |
Primary outcome
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Time frame: Day 0 up to 70 days post first vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis N Morrison, D.O. principal investigator
Bio-Kinetic Clinical Applications, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg) and Clostridium difficile toxoid vaccine (100 μg) in people with Clostridium Difficile Infection and Clostridium Difficile Diarrhea, run by Sanofi.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. (time frame: Day 0 up to 70 days post first vaccination). 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 21 May 2012.