To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults

Last updated: November 18, 2024
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

C. difficile vaccine formulation 3

C. difficile vaccine formulation 2

C. difficile vaccine formulation 2.

Clinical Study ID

NCT05805826
C4771001
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

An antibody is a substance your body makes to fight off infection. This study will explore the safety and antibody response of a vaccine to prevent severe diarrhea caused by a germ called Clostridoides difficile (C. diff). Three new formulations of the C. diff vaccine will be used in this study, in addition to a C. diff vaccine formulation that has been studied in previous clinical trials.

The purpose of this study is to understand if giving the new C. diff vaccine formulations helps people make as many antibodies as giving the previously studied C. diff vaccine formulation.

The study is divided into 2 phases.

Phase 1 will evaluate 3 new formulations of the C. diff vaccine and 2 dosing schedules spread out over 2 months or 6 months.

The Phase 1 portion of the study is seeking participants:

  • who are healthy adults of 65 to 84 years of age

  • who have not had a C. diff infection before

  • who have not received a C. diff vaccine or C. diff monoclonal antibody therapy before.

All participants in Phase 1 will receive study injections with active vaccine or placebo at each vaccination visit, depending on the vaccine group to which they are assigned. A placebo does not contain any active ingredients. Participants in Phase 1 will attend at least 9 study visits and will take part in the study for approximately 18 months. Based on the results of Phase 1, 1 or 2 of the new C. diff vaccine formulations will be chosen for further study in Phase 2.

Phase 2 will evaluate the safety and effects of the new C. diff vaccine formulation(s) chosen in Phase 1.

The Phase 2 portion of the study is seeking participants:

  • who are healthy adults ≥65 years of age

  • who have not had a C. diff infection before

  • who have not received a C. diff vaccine or C. diff monoclonal antibody therapy before.

Phase 2 participants will receive active C. diff vaccine or placebo at each vaccination visit. Participants in Phase 2 will attend at least 6 and up to 12 study visits and will take part in the study for up to 4 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Healthy participants as determined by medical history, clinical assessment, and thejudgment of the investigator.

  3. Participants who are willing and able to comply with all scheduled visits,investigational plan, laboratory tests, lifestyle considerations, and other studyprocedures.

  4. 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:

  1. 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.

  2. 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.

  3. Any contraindication to vaccination or vaccine components, including previoushypersensitivity or anaphylactic reaction to any vaccine or vaccine-relatedcomponents.

  4. Prior episode of CDI, confirmed by either laboratory test or diagnosis ofpseudomembranous colitis at colonoscopy, at surgery, or histopathologically.

  5. Any bleeding disorder or anticoagulant therapy that would contraindicateintramuscular injection.

  6. 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.

  7. 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.

  8. Previous receipt of an investigational C difficile vaccine or C difficile mAbtherapy.

  9. Receipt of blood product or immunoglobulin within 6 months before enrollment.

  10. 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.

  11. 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.

  12. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value thatmeets the definition of a ≥ Grade 1 abnormality.

  13. 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

Total Participants: 689
Treatment Group(s): 10
Primary Treatment: C. difficile vaccine formulation 3
Phase: 1/2
Study Start date:
March 23, 2023
Estimated Completion Date:
August 28, 2028

Connect with a study center

  • HOPE Research Institute

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • The Pain Center of Arizona

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Anaheim Clinical Trials, LLC

    Anaheim, California 92801
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Centers of America ( Hollywood )

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Charisma Medical and Research Center

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • DBC Research USA

    Pembroke Pines, Florida 33029
    United States

    Site Not Available

  • Private Practice - Dr. Hector Fabregas

    Pembroke Pines, Florida 33026
    United States

    Site Not Available

  • BRCR Medical Center Inc.

    Plantation, Florida 33322
    United States

    Site Not Available

  • Clinical Research Trials of Florida

    Tampa, Florida 33607
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Benchmark Research

    Austin, Texas 78705
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • DM Clinical Research - MDC

    Tomball, Texas 77375
    United States

    Site Not Available

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