Clinical trial NCT03579459: Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
Official title: A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS 65 TO 85 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Clostridium Difficile Associated Disease
Keywords: Clostridium Difficile
vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 1317
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Detailed description: Serology for B5091008 was delayed due to discussions with the FDA on statistical analysis as well as delays attributed to the COVID pandemic.

Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document.
* Willing and able to comply with study procedures.
* Healthy adults 65 to 85 years of age.
* Male subjects or female subjects who are not of childbearing potential.
* Ability to be contacted by telephone during study participation.

Exclusion Criteria:

* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry through conclusion of the study.
* Previous administration of an investigational C difficile vaccine or C difficile monoclonal antibody therapy.
* Proven or suspected prior episode of C difficile infection.
* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of investigational product.
* Serious chronic medical disorders, including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease.
* Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Subjects who may be unable to respond to vaccination due to:

  * Congenital or acquired immunodeficiency.
  * Receipt of systemic corticosteroids (greater than or equal to 20 mg/day of prednisone or equivalent) for greater than or equal to 14 days within 28 days of enrollment.
  * Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
  * Underlying bone marrow disorder treated within the past year, such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.
  * Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.
* Receipt of blood products or immunoglobulins within 6 months before enrollment through conclusion of the study.
* Residence in a nursing home or other long-term care facility, or 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.
* A known infection with human immunodeficiency virus (HIV).
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavioral 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.
* Female subjects of childbearing potential; pregnant female subjects; breastfeeding female subjects; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Primary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7
timeFrame: At Month 7
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1 at Month 0
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2 at Month 1
measure: Percentage of Participants Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3 at Month 6
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1 at Month 0
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2 at Month 1
measure: Percentage of Participants Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3 at Month 6
measure: Percentage of Participants With Adverse Events (AEs) Through 1 Month After Last Study Vaccination
timeFrame: From Day 1 to 1 month after last vaccination (Up to Month 7)
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 1 to 1 month after last vaccination (Up to Month 7)
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Goose Creek
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Draper
country: United States
facility: J. Lewis Research Inc. / Foothill Family Clinic Draper
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc./ Foothill Family Clinic South
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Incorporated/Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: