Clostridium DifficilePhase 1NCT02052726
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
A Phase 1 study testing C. difficile vaccine with adjuvant in people with Clostridium Difficile, run by Pfizer at 10 sites in 2 countries.
Trial summary
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- C. difficile vaccine with adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 22 Jan 2014to 5 May 2015
- Phase
- Phase 1
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults aged 50 to 85 years at enrollment
Who cannot join
- Proven or suspected prior episode of Clostridium difficile associated diarrhea.
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States6 sites
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary, North Carolina, 27518
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
Carolina Phase I Research, LLC
Raleigh, North Carolina, 27612
Canada4 sites
Diex Research Montreal Inc
Montreal, Quebec, H4N 3C5
Clinique Medicale St-Louis (recherche) Inc.
Québec, Quebec, G1W4R4
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1
Manna Research Inc.
Toronto, Ontario, M9W 4L6
About this study
Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
- Conditions
- Clostridium Difficile
- Being tested
- C. difficile vaccine with adjuvant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. difficile vaccine with adjuvantBiological
- difficile vaccine with adjuvant administered at Month 0, 1, and 3.
PlaceboBiological
Placebo administered at Month 0, 1, and 3.
C. difficile vaccine with adjuvantBiological
- difficile vaccine with adjuvant administered at day 1, 8, 30.
placeboBiological
Placebo administered at Day 1, 8, and 30.
| Study group | Role | What they receive |
|---|---|---|
| Arm Label: Month 0, 1 and 3 Schedule | Experimental | Not described Receives: Biological: C. difficile vaccine with adjuvant; Biological: Placebo |
| Day 1, 8, and 30 Schedule | Experimental | Not described Receives: Biological: C. difficile vaccine with adjuvant; Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
Measured: 7 days after vaccination
Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.
Measured: 7 days after vaccination
Secondary outcomes (3)
Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
Measured: Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
Measured: Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).
Measured: Up to 12 months post-dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start22 Jan 2014
- Primary completion2 May 2015
- Study completion5 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052726
- Sponsor's protocol ID
- B5091002
- Status last verified
- Nov 2018
- First submitted
- 17 Dec 2013
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
- ClinicalTrials.gov ID
- NCT02052726
- Acronym / sponsor ID
- B5091002
- Conditions
- Clostridium Difficile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2014 (actual)
- Primary completion
- 2 May 2015 (actual)
- Study completion
- 5 May 2015 (actual)
- First posted
- 3 Feb 2014 (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.
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Label: Month 0, 1 and 3 Schedule | Experimental | Biological: C. difficile vaccine with adjuvant, Biological: Placebo |
| Day 1, 8, and 30 Schedule | Experimental | Biological: C. difficile vaccine with adjuvant, Biological: placebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female adults aged 50 to 85 years at enrollment
Key exclusion criteria (3 listed)
- Proven or suspected prior episode of Clostridium difficile associated diarrhea.
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
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 |
|---|---|---|
| C. difficile vaccine with adjuvantC. difficile vaccine with adjuvant administered at Month 0, 1, and 3. | Biological | Arm Label: Month 0, 1 and 3 Schedule |
| PlaceboPlacebo administered at Month 0, 1, and 3. | Biological | Arm Label: Month 0, 1 and 3 Schedule |
| C. difficile vaccine with adjuvantC. difficile vaccine with adjuvant administered at day 1, 8, 30. | Biological | Day 1, 8, and 30 Schedule |
| placeboPlacebo administered at Day 1, 8, and 30. | Biological | Day 1, 8, and 30 Schedule |
Primary outcome
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
Time frame: 7 days after vaccination
Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.
Time frame: 7 days after vaccination
3 secondary outcomes
Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
Time frame: Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
Time frame: Up to 12 months post-dose 3
Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).
Time frame: Up to 12 months post-dose 3
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 4 Dec 2018.
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Clostridioides Difficile Infection
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C. difficile vaccine with adjuvant in people with Clostridium Difficile, run by Pfizer at 10 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 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: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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. 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?
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?
Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries. (time frame: 7 days after vaccination). The study lists 2 primary outcomes in all. 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 4 Dec 2018.