NCT01706367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

September 7, 2012

Last Update Submit

March 5, 2014

Conditions

Clostridium Difficile Associated Disease

Keywords

Clostridium difficilevaccine

Outcome Measures

Primary Outcomes (4)

  • Number subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on eDiaries for 7 days following each vaccination.

    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.

    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.

    7 months (AEs) 12 months (SAEs)

  • Number of subjects with abnormal hematology and blood chemistry laboratory assessments after each vaccination dose.

    Day 3, Day 14, Month 1, Day 37, Month 6, Day 187

Secondary Outcomes (4)

  • Neutralizing antibody levels at Month 2.

    Month 2

  • Neutralizing antibody levels after each vaccination dose.

    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.

    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.

    Baseline, Day 14, Month 1, Day 37, Month 2, Month 6, Day 187, Month 7

Study Arms (6)

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

Interventions

C. difficile vaccineBIOLOGICAL

0.5 mL IM injection

Low dose C diff vaccine
C. difficile vaccine +adjuvantBIOLOGICAL

0.5 mL IM injection

Low dose C diff vaccine + adjuvant

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Pembroke Pines, Florida, 33026, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Cary, North Carolina, 27518, United States

Location

Related Publications (1)

  • 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.

    PMID: 26993331DERIVED

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

October 15, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

US(4)