Clostridium Difficile InfectionPhase 1/2NCT01896830
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan
A Phase 1/2 study testing Clostridium difficile Toxoid Vaccine and 0.9% normal saline in people with Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in Japan.
Trial summary
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population. Primary objectives: To describe the safety profile of all subjects who receive at least 1 injection To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Clostridium difficile Toxoid Vaccine and 0.9% normal saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2013to Jun 2014
- Phase
- Phase 1/2
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult subjects aged 40 to 75 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine.
- Planned receipt of any vaccine between study vaccinations and in the 4 weeks following the last trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
- Previous vaccination against C. difficile with either the trial vaccine another vaccine, or monoclonal antibodies
- Self-reported current or prior Clostridium difficile infection (CDI) episode
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- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Known systemic hypersensitivity to any of the vaccine components (including aluminum hydroxide, sodium citrate,sucrose, formaldehyde, sodium chloride), or history of a life-threatening reaction to a vaccine containing any of the same substances
- Known medical history or concomitant disease of thrombocytopenia
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Subjects who have any history of intestinal diverticular bleeding
- Subjects who have had surgery within the past three months for Gastro-Intestinal malignancy
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.5°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Subject who has concomitant disease that, according to investigator's/sub-investigator's judgment, would adversely affect the safety of the subject in the study, e.g., cardiovascular disease, renal disease, hepatic disease, hematologic disease, and/or growth impairment
- Subject with a past history of convulsions
- Subject ineligible for participation in the study according to the investigator's/sub-investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.
Primary objectives:
- To describe the safety profile of all subjects who receive at least 1 injection
- To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.
Read the detailed description
Participants will be randomly assigned to receive the vaccine or placebo on the selected schedule. Safety parameters, solicited injection site and systemic reactions will be collected for 6 days after each injection; unsolicited adverse events including serious adverse events will be collected up to Day 60 post-vaccination.
- Conditions
- Clostridium Difficile Infection
- Being tested
- Clostridium difficile Toxoid Vaccine, 0.9% normal saline
- Keywords
- Clostridium difficile infection, 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.
Clostridium difficile Toxoid VaccineBiological
0.5 mL, intramuscular
0.9% normal salineBiological
Also called NaCl
0.5 mL, intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Group | Experimental | Participants will receive the candidate C. difficile toxoid vaccine Receives: Biological: Clostridium difficile Toxoid Vaccine |
| Placebo Group | Placebo comparator | Participants will receive a placebo vaccine Receives: Biological: 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Measured: Day 0 up to Day 60 post-vaccination
Serum antibody concentrations to toxins A and B, measured by enzyme-linked immunosorbent assay (ELISA)
Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
Serum antibody titers against toxins A and B, measured by toxin neutralizing assay
Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
Measured: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 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 K.K
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896830
- Sponsor's protocol ID
- CDI19 (DFI13360)
- Other IDs
- U1111-1127-7547
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2013
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuoka O, Patel DM, Sasaki S, Oka H, Sasaki T, Pietrobon PJ, Laot T, Bouckenooghe A, Menezes J, de Bruyn G. Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. Hum Vaccin Immunother. 2018 Feb 1;14(2):322-328. doi: 10.1080/21645515.2017.1395538. Epub 2017 Dec 6.
PubMed 29116880
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan
- ClinicalTrials.gov ID
- NCT01896830
- Acronym / sponsor ID
- CDI19 (DFI13360)
- Conditions
- Clostridium Difficile Infection
- Keywords
- Clostridium difficile infection, Clostridium difficile Toxoid Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jul 2013 (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.
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.
Primary objectives:
- To describe the safety profile of all subjects who receive at least 1 injection
- To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.
Detailed description
Participants will be randomly assigned to receive the vaccine or placebo on the selected schedule. Safety parameters, solicited injection site and systemic reactions will be collected for 6 days after each injection; unsolicited adverse events including serious adverse events will be collected up to Day 60 post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Group | Experimental | Biological: Clostridium difficile Toxoid VaccineParticipants will receive the candidate C. difficile toxoid vaccine |
| Placebo Group | Placebo comparator | Biological: 0.9% normal salineParticipants will receive a placebo vaccine |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult subjects aged 40 to 75 years on the day of inclusion
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (21 listed)
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine.
- Planned receipt of any vaccine between study vaccinations and in the 4 weeks following the last trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
- Previous vaccination against C. difficile with either the trial vaccine another vaccine, or monoclonal antibodies
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 |
|---|---|---|
| Clostridium difficile Toxoid Vaccine0.5 mL, intramuscular | Biological | Vaccine Group |
| 0.9% normal salineAlso: NaCl0.5 mL, intramuscular | Biological | Placebo Group |
Primary outcome
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial
Time frame: Day 0 up to Day 60 post-vaccination
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Serum antibody concentrations to toxins A and B, measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
Serum antibody titers against toxins A and B, measured by toxin neutralizing assay
Time frame: Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination
Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
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 18 Jul 2018.
- Results publication: PubMed 29116880Matsuoka O, Patel DM, Sasaki S, Oka H, Sasaki T, Pietrobon PJ, Laot T, Bouckenooghe A, Menezes J, de Bruyn G. Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. Hum Vaccin Immunother. 2018 Feb 1;14(2):322-328. doi: 10.1080/21645515.2017.1395538. Epub 2017 Dec 6.
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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 K.K
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Clostridium difficile Toxoid Vaccine and 0.9% normal saline in people with Clostridium Difficile Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in Japan.
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 3 inclusion and 21 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 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 combined 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.
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?
Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial (time frame: Day 0 up to Day 60 post-vaccination). The study lists 3 primary outcomes in all. 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 NCT01896830, 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 18 Jul 2018.