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

NCT01706367

Last updated date
Study Location
Pfizer Investigational Site
Pembroke Pines, Florida, 33026, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Associated Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Evidence of a personally signed and dated informed consent document.

2. 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.

3. 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).

4. 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

- Are medically confirmed to be postmenopausal

5. 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.

6. Ability to be contacted by telephone during study participation.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Previous administration of an investigational C. difficile vaccine or C. difficile
monoclonal antibody therapy.


2. Proven or suspected prior episode of CDAD.


3. Unstable chronic medical condition or disease requiring significant change in therapy
or hospitalization for worsening disease within 12 weeks before receipt of study
vaccine.


4. 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.


5. 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.


6. 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).


7. Any contraindication to vaccination or vaccine components.


8. "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."


9. Subjects who received oral or parenteral antibiotics within 1 month before enrollment.
Topical antibiotics are allowed.


10. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within
6 months before enrollment through conclusion of the study.


11. 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.


12. 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.


13. 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).


14. Females receiving exogenous estrogen therapy.


15. 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.


16. 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.


17. A positive screening test or known infection with human immunodeficiency virus (HIV),
hepatitis B virus (HBV) and/or hepatitis C virus (HCV).


18. 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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. In addition, the study aims to assess the immune response to the C difficile vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Clostridium Difficile Associated Disease
Intervention  ICMJE
  • Biological: C. difficile vaccine
    0.5 mL IM injection
  • Biological: C. difficile vaccine +adjuvant
    0.5 mL IM injection
Study Arms  ICMJE
  • Experimental: Low dose C diff vaccine
    Intervention: Biological: C. difficile vaccine
  • Experimental: Low dose C diff vaccine + adjuvant
    Intervention: Biological: C. difficile vaccine +adjuvant
  • Experimental: Mid dose C diff vaccine
    Intervention: Biological: C. difficile vaccine
  • Experimental: Mid dose C diff vaccine + adjuvant
    Intervention: Biological: C. difficile vaccine +adjuvant
  • Experimental: High dose C diff vaccine
    Intervention: Biological: C. difficile vaccine
  • Experimental: High dose C diff vaccine + adjuvant
    Intervention: Biological: C. difficile vaccine +adjuvant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 11, 2012)
192
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document.
  2. 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.
  3. 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).
  4. 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
    • Are medically confirmed to be postmenopausal
  5. 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.
  6. Ability to be contacted by telephone during study participation.

Exclusion Criteria:

  1. Previous administration of an investigational C. difficile vaccine or C. difficile monoclonal antibody therapy.
  2. Proven or suspected prior episode of CDAD.
  3. Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 12 weeks before receipt of study vaccine.
  4. 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.
  5. 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.
  6. 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).
  7. Any contraindication to vaccination or vaccine components.
  8. "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."
  9. Subjects who received oral or parenteral antibiotics within 1 month before enrollment. Topical antibiotics are allowed.
  10. Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months before enrollment through conclusion of the study.
  11. 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.
  12. 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.
  13. 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).
  14. Females receiving exogenous estrogen therapy.
  15. 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.
  16. 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.
  17. A positive screening test or known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
  18. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01706367
Other Study ID Numbers  ICMJE B5091001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP