Clostridium InfectionsPhase 1NCT00214461
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
A Phase 1 study testing C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg) and C. difficile toxoid vaccine (50 µg) in people with Clostridium Infections, run by Sanofi at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged > or = 65 years. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clostridium Infections
- What is being tested?
- C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg) and C. difficile toxoid vaccine (50 µg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Feb 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adult males or females, > or = 65 years
- In good general health
- Clinical lab tests within normal range
- Females must be post-menopausal
- Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Who cannot join
- Evidence of C. difficile infection
- Evidence of any previous antibiotic-associated diarrhea
- Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
- Known or suspected history of immunodeficiency
Show all 11Show fewer
- Active or inactive immune-mediated or inflammatory disease
- History of drug or alcohol abuse disorders;
- Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Receipt of antibiotic therapy or an investigational drug within prior 30 days
- Blood or organ donation within prior 30 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky
Lexington, Kentucky, 40536
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Elderly Volunteers (> or =65 Years)
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Read the detailed description
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.
- Conditions
- Clostridium Infections
- Being tested
- Vaccine diluent buffer (Placebo), C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg)
- Keywords
- Clostridium difficile
- 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 buffer (Placebo)Biological
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
C. difficile toxoid vaccine (2 µg)Biological
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
C. difficile toxoid vaccine (10 µg)Biological
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
C. difficile toxoid vaccine (50 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 will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively. Receives: Biological: Vaccine diluent buffer (Placebo) |
| Low Dose Vaccine Group | Experimental | Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. Receives: Biological: C. difficile toxoid vaccine (2 µg) |
| Medium dose vaccine group | Experimental | Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. Receives: Biological: C. difficile toxoid vaccine (10 µg) |
| High dose vaccine group | Experimental | Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. Receives: Biological: C. difficile toxoid vaccine (50 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 Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Measured: Day 0 to up to 70 days post first vaccination
Secondary outcomes (1)
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject's specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).
Measured: Day up to Day 236 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 posted22 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas P Marbury, MD, Principal investigator, Orlando Clinical Research CenterRichard Greenberg, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214461
- Sponsor's protocol ID
- H-030-009
- Status last verified
- Apr 2012
- First submitted
- 16 Sep 2005
- Last updated
- 11 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Greenberg RN, Marbury TC, Foglia G, Warny M. Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine. Vaccine. 2012 Mar 16;30(13):2245-9. doi: 10.1016/j.vaccine.2012.01.065. Epub 2012 Feb 2.
PubMed 22306375
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 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 a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Elderly Volunteers (> or =65 Years)
- ClinicalTrials.gov ID
- NCT00214461
- Acronym / sponsor ID
- H-030-009
- Conditions
- Clostridium Infections
- Keywords
- Clostridium difficile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 9 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Detailed description
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Vaccine Group | Placebo comparator | Biological: Vaccine diluent buffer (Placebo)Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively. |
| Low Dose Vaccine Group | Experimental | Biological: C. difficile toxoid vaccine (2 µg)Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
| Medium dose vaccine group | Experimental | Biological: C. difficile toxoid vaccine (10 µg)Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
| High dose vaccine group | Experimental | Biological: C. difficile toxoid vaccine (50 µg)Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adult males or females, > or = 65 years
- In good general health
- Clinical lab tests within normal range
- Females must be post-menopausal
- Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Key exclusion criteria (11 listed)
- Evidence of C. difficile infection
- Evidence of any previous antibiotic-associated diarrhea
- Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
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 buffer (Placebo)0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. | Biological | Placebo Vaccine Group |
| C. difficile toxoid vaccine (2 µg)0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. | Biological | Low Dose Vaccine Group |
| C. difficile toxoid vaccine (10 µg)0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively. | Biological | Medium dose vaccine group |
| C. difficile toxoid vaccine (50 µg)0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively. | Biological | High dose vaccine group |
Primary outcome
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Time frame: Day 0 to up to 70 days post first vaccination
1 secondary outcome
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Time frame: Day up to Day 236 post first vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22306375Greenberg RN, Marbury TC, Foglia G, Warny M. Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine. Vaccine. 2012 Mar 16;30(13):2245-9. doi: 10.1016/j.vaccine.2012.01.065. Epub 2012 Feb 2.
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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.
Thomas P Marbury, MD principal investigator
Orlando Clinical Research Center
Richard Greenberg, MD principal investigator
University of Kentucky
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg) and C. difficile toxoid vaccine (50 µg) in people with Clostridium Infections, run by Sanofi at 2 sites in United States.
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 5 inclusion and 11 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 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 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 9 Apr 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 Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine. (time frame: Day 0 to 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?
On the ClinicalTrials.gov record for NCT00214461, which also lists 1 linked publication.
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 11 Apr 2012.