Phase
Condition
N/ATreatment
C. difficile vaccine formulation 3
C. difficile vaccine formulation 2
C. difficile vaccine formulation 2.
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Each phase of the study will enroll participants in different age categories: Phase 1: Participants ≥65 to <85 years of age; Phase 2: Participants ≥65 years ofage.
Healthy participants as determined by medical history, clinical assessment, and thejudgment of the investigator.
Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.
Capable of giving personally signed informed consent, which includes compliance withthe requirements and restrictions listed in the ICD and in this protocol.
Exclusion
Exclusion Criteria:
Fertile male participants and WOCBP who are unwilling or unable to use an effectivemethod of contraception from the signing of informed consent until at least 28 daysafter the last dose of study intervention.
Serious chronic disorder, including history of metastatic malignancy, severe COPDrequiring supplemental oxygen, end-stage renal disease with or without dialysis,cirrhosis of the liver, clinically unstable cardiac disease, or any other disorderthat, in the investigator's opinion, would make the participant inappropriate forentry into the study.
Any contraindication to vaccination or vaccine components, including previoushypersensitivity or anaphylactic reaction to any vaccine or vaccine-relatedcomponents.
Prior episode of CDI, confirmed by either laboratory test or diagnosis ofpseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
Any bleeding disorder or anticoagulant therapy that would contraindicateintramuscular injection.
Known or suspected immunodeficiency or other conditions associated withimmunosuppression, including, but not limited to, leukocyte, lymphocyte, orimmunoglobulin class/subclass deficiencies or abnormalities, generalized malignancy,HIV infection, leukemia, lymphoma, or organ or bone marrow transplant.
Other medical or psychiatric condition including recent (within the past year) oractive suicidal ideation/behavior or laboratory abnormality that may increase therisk of study participation or, in the investigator's judgment, make the participantinappropriate for the study.
Previous receipt of an investigational C difficile vaccine or C difficile mAbtherapy.
Receipt of blood product or immunoglobulin within 6 months before enrollment.
Currently receives treatment with immunosuppressive therapy, including cytotoxicagents or systemic corticosteroids, or planned receipt throughout the study.Participants may not be enrolled if corticosteroids were administered within 28 daysbefore study intervention administration.
Participation in other studies involving investigational drugs, investigationalvaccines, or investigational devices within 28 days prior to study entry through 12months after the last dose of study intervention.
Phase 1 only: Any screening hematology and/or blood chemistry laboratory value thatmeets the definition of a ≥ Grade 1 abnormality.
Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff otherwise supervised by the investigator, and sponsor andsponsor delegate employees directly involved in the conduct of the study and theirfamily members.
Study Design
Connect with a study center
HOPE Research Institute
Phoenix, Arizona 85032
United StatesSite Not Available
Hope Research Institute
Phoenix, Arizona 85018
United StatesSite Not Available
The Pain Center of Arizona
Phoenix, Arizona 85018
United StatesSite Not Available
Anaheim Clinical Trials, LLC
Anaheim, California 92801
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Coral Gables, Florida 33134
United StatesSite Not Available
Indago Research & Health Center, Inc
Hialeah, Florida 33012
United StatesSite Not Available
Research Centers of America
Hollywood, Florida 33024
United StatesSite Not Available
Research Centers of America ( Hollywood )
Hollywood, Florida 33024
United StatesSite Not Available
Miami Clinical Research
Miami, Florida 33155
United StatesSite Not Available
New Horizon Research Center
Miami, Florida 33165
United StatesSite Not Available
Charisma Medical and Research Center
Miami Lakes, Florida 33014
United StatesSite Not Available
DBC Research USA
Pembroke Pines, Florida 33029
United StatesSite Not Available
Private Practice - Dr. Hector Fabregas
Pembroke Pines, Florida 33026
United StatesSite Not Available
BRCR Medical Center Inc.
Plantation, Florida 33322
United StatesSite Not Available
Clinical Research Trials of Florida
Tampa, Florida 33607
United StatesSite Not Available
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640
United StatesSite Not Available
Great Lakes Clinical Trials - Gurnee
Gurnee, Illinois 60031
United StatesSite Not Available
Alliance for Multispecialty Research, LLC
Wichita, Kansas 67207
United StatesSite Not Available
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota 55114
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
Rochester Clinical Research, Inc.
Rochester, New York 14609
United StatesActive - Recruiting
Rochester Clinical Research, LLC
Rochester, New York 14609
United StatesSite Not Available
CTI Clinical Research Center
Cincinnati, Ohio 45212
United StatesSite Not Available
Benchmark Research
Austin, Texas 78705
United StatesSite Not Available
DM Clinical Research
Tomball, Texas 77375
United StatesActive - Recruiting
DM Clinical Research - MDC
Tomball, Texas 77375
United StatesSite Not Available
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