Clostridium Difficile Associated DiseasePhase 1NCT01706367
Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years
A Phase 1 study testing C. difficile vaccine and C. difficile vaccine +adjuvant in people with Clostridium Difficile Associated Disease, run by Pfizer at 4 sites in United States.
Trial summary
This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. 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 Associated Disease
- What is being tested?
- C. difficile vaccine and C. difficile vaccine +adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2012to Jan 2014
- 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
- Evidence of a personally signed and dated informed consent document.
- Healthy male and female adults aged 50 to 85 years at enrollment as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
- Male subjects who, in the opinion of the investigator, are biologically capable of fathering children, and who are sexually active with women of childbearing potential must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after the last dose of investigational product (through Visit 9 at Month 7).
- Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
- Have undergone hysterectomy or bilateral oophorectomy;
- Have medically confirmed ovarian failure or
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- Are medically confirmed to be postmenopausal
- Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (eDiary) from Day 1 to Day 7 following each vaccination.
- Ability to be contacted by telephone during study participation.
Who cannot join
- Previous administration of an investigational C. difficile vaccine or C. difficile monoclonal antibody therapy.
- Proven or suspected prior episode of CDAD.
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 12 weeks before receipt of study vaccine.
- Serious chronic medical disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) , end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.
- Donation of blood volume of 250 mL or greater, or donation of plasma within 3 months prior to enrollment or during the conduct of the study.
- Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection or blood draw including subjects taking anticoagulant, antiplatelet and/or antithrombotic agents except for low dose daily aspirin (≤325mg per day) within 30 days before enrollment through completion of Visit 9 (Month 7).
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- Any contraindication to vaccination or vaccine components.
- "Immunocompromised persons or subjects currently on immunosuppressive therapy or with a history of immunosuppressive therapy, including chemotherapy agents for treatment of diseases including, but not limited to cancer, inflammatory bowel disease or autoimmune disease. Recent history (within the past 6 months) of long term (7 days or longer) systemic corticosteroid use."
- Subjects who received oral or parenteral antibiotics within 1 month before enrollment. Topical antibiotics are allowed.
- Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months before enrollment through conclusion of the study.
- Participation in other investigational or interventional studies within 30 days before the current study begins and/or during study participation. Participation in purely observational studies is acceptable.
- Subjects who are investigational site staff members or relatives of those site staff members, or subjects who are Pfizer employees directly involved in the conduct of the trial.
- Females of childbearing potential; males of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after last dose of investigational product (through Visit 9 at Month 7).
- Females receiving exogenous estrogen therapy.
- Residence in a nursing home, long-term care facility, requirement for semiskilled nursing care or assisted living. An ambulatory subject who lives in an autonomous manner in a retirement home or village is eligible for the trial.
- Any abnormality in screening hematology and/or blood chemistry laboratory values according to the toxicity grading scale. Subjects with stable Grade 1 abnormalities for hemoglobin, leukocyte count, and platelets may be considered eligible at the discretion of the investigator.
- A positive screening test or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pfizer Investigational Site
Cary, North Carolina, 27518
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Pembroke Pines, Florida, 33026
Pfizer Investigational Site
South Miami, Florida, 33143
About this study
Official title: A Phase 1, Placebo-Controlled, Randomized, Observer-Blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Clostridium Difficile Vaccine Administered With Or Without Adjuvant, In A 3-Dose Regimen In Healthy Adults Aged 50 To 85 Years
This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study aims to assess the immune response to the C difficile vaccine.
- Conditions
- Clostridium Difficile Associated Disease
- Being tested
- C. difficile vaccine, C. difficile vaccine +adjuvant
- Keywords
- Clostridium difficile, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. difficile vaccineBiological
0.5 mL IM injection
C. difficile vaccine +adjuvantBiological
0.5 mL IM injection
C. difficile vaccineBiological
0.5 mL IM injection
C. difficile vaccine +adjuvantBiological
0.5 mL IM injection
C. difficile vaccineBiological
0.5 mL IM injection
C. difficile vaccine +adjuvantBiological
0.5 mL IM injection
| Study group | Role | What they receive |
|---|---|---|
| Low dose C diff vaccine | Experimental | Not described Receives: Biological: C. difficile vaccine |
| Low dose C diff vaccine + adjuvant | Experimental | Not described Receives: Biological: C. difficile vaccine +adjuvant |
| Mid dose C diff vaccine | Experimental | Not described Receives: Biological: C. difficile vaccine |
| Mid dose C diff vaccine + adjuvant | Experimental | Not described Receives: Biological: C. difficile vaccine +adjuvant |
| High dose C diff vaccine | Experimental | Not described Receives: Biological: C. difficile vaccine |
| High dose C diff vaccine + adjuvant | Experimental | Not described Receives: Biological: C. difficile vaccine +adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.
Measured: 7 days
Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.
Measured: 7 days
Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.
Measured: 7 months (AEs) 12 months (SAEs)
Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.
Measured: Day 3, Day 14, Month 1, Day 37, Month 6, Day 187
Secondary outcomes (4)
Neutralizing antibody levels at Month 2.
Measured: Month 2
Neutralizing antibody levels after each vaccination dose.
Measured: Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7
Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.
Measured: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
Number of subjects in each treatment group with neutralizing antibody levels ≥ a specified threshold after each vaccination dose.
Measured: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 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 Associated DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 192 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
- NCT01706367
- Sponsor's protocol ID
- B5091001
- Status last verified
- Mar 2014
- First submitted
- 7 Sep 2012
- Last updated
- 6 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheldon E, Kitchin N, Peng Y, Eiden J, Gruber W, Johnson E, Jansen KU, Pride MW, Pedneault L. A phase 1, placebo-controlled, randomized study of the safety, tolerability, and immunogenicity of a Clostridium difficile vaccine administered with or without aluminum hydroxide in healthy adults. Vaccine. 2016 Apr 19;34(18):2082-91. doi: 10.1016/j.vaccine.2016.03.010. Epub 2016 Mar 15.
PubMed 26993331
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. 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 A Clostridium Difficile Vaccine Administered With Or Without Adjuvant, In A 3-Dose Regimen In Healthy Adults Aged 50 To 85 Years
- ClinicalTrials.gov ID
- NCT01706367
- Acronym / sponsor ID
- B5091001
- Conditions
- Clostridium Difficile Associated Disease
- Keywords
- Clostridium difficile, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Oct 2012 (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 is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study aims to assess the immune response to the C difficile vaccine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low dose C diff vaccine | Experimental | Biological: C. difficile vaccine |
| Low dose C diff vaccine + adjuvant | Experimental | Biological: C. difficile vaccine +adjuvant |
| Mid dose C diff vaccine | Experimental | Biological: C. difficile vaccine |
| Mid dose C diff vaccine + adjuvant | Experimental | Biological: C. difficile vaccine +adjuvant |
| High dose C diff vaccine | Experimental | Biological: C. difficile vaccine |
| High dose C diff vaccine + adjuvant | Experimental | Biological: C. difficile vaccine +adjuvant |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Evidence of a personally signed and dated informed consent document.
- Healthy male and female adults aged 50 to 85 years at enrollment as determined by medical history, physical examination, and the clinical judgment of the investigator to be eligible for the study. Subjects with preexisting chronic medical conditions determined to be stable may be included.
- Male subjects who, in the opinion of the investigator, are biologically capable of fathering children, and who are sexually active with women of childbearing potential must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after the last dose of investigational product (through Visit 9 at Month 7).
- Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
- Availability for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary (eDiary) from Day 1 to Day 7 following each vaccination.
Key exclusion criteria (18 listed)
- Previous administration of an investigational C. difficile vaccine or C. difficile monoclonal antibody therapy.
- Proven or suspected prior episode of CDAD.
- Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 12 weeks before receipt of study vaccine.
- Serious chronic medical disorders including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) , end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.
- Donation of blood volume of 250 mL or greater, or donation of plasma within 3 months prior to enrollment or during the conduct of the study.
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 vaccine0.5 mL IM injection | Biological | Low dose C diff vaccine |
| C. difficile vaccine +adjuvant0.5 mL IM injection | Biological | Low dose C diff vaccine + adjuvant |
| C. difficile vaccine0.5 mL IM injection | Biological | Mid dose C diff vaccine |
| C. difficile vaccine +adjuvant0.5 mL IM injection | Biological | Mid dose C diff vaccine + adjuvant |
| C. difficile vaccine0.5 mL IM injection | Biological | High dose C diff vaccine |
| C. difficile vaccine +adjuvant0.5 mL IM injection | Biological | High dose C diff vaccine + adjuvant |
Primary outcome
Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.
Time frame: 7 days
Number of subjects reporting systemic reactions (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on eDiaries for 7 days following each vaccination.
Time frame: 7 days
Number of subjects reporting AEs from day 1 (at the time of vaccination) up to 28 days post Dose 3 (visit 9, month 7) and SAEs throughout the study period.
Time frame: 7 months (AEs) 12 months (SAEs)
Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.
Time frame: Day 3, Day 14, Month 1, Day 37, Month 6, Day 187
4 secondary outcomes
Neutralizing antibody levels at Month 2.
Time frame: Month 2
Neutralizing antibody levels after each vaccination dose.
Time frame: Baseline, Day 14, Month 1, Day 37, Month 6, Day 187, Month 7
Number of subjects in each treatment group with 4 and higher fold-rises in neutralizing antibody levels after each vaccination dose.
Time frame: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
Number of subjects in each treatment group with neutralizing antibody levels ≥ a specified threshold after each vaccination dose.
Time frame: Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7
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 6 Mar 2014.
- Derived from this study: PubMed 26993331Sheldon E, Kitchin N, Peng Y, Eiden J, Gruber W, Johnson E, Jansen KU, Pride MW, Pedneault L. A phase 1, placebo-controlled, randomized study of the safety, tolerability, and immunogenicity of a Clostridium difficile vaccine administered with or without aluminum hydroxide in healthy adults. Vaccine. 2016 Apr 19;34(18):2082-91. doi: 10.1016/j.vaccine.2016.03.010. Epub 2016 Mar 15.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
4 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 vaccine and C. difficile vaccine +adjuvant in people with Clostridium Difficile Associated Disease, run by Pfizer at 4 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 9 inclusion and 18 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 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination. (time frame: 7 days). The study lists 4 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 NCT01706367, 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 6 Mar 2014.