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The trial is taking place at:
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Benchmark Research | Austin, TX

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To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons. It Will Be Given Twice Over a Period of Time to Healthy Adults

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Pfizer

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Clostridoides Difficile Associated Disease

Treatments

Biological: C. difficile vaccine (previously studied formulation).
Biological: C. difficile vaccine formulation 1.
Other: Saline Placebo.
Biological: C. difficile vaccine formulation 2.
Biological: C. difficile vaccine formulation 3.

Study type

Interventional

Funder types

Industry

Identifiers

NCT05805826
C4771001

Details and patient eligibility

About

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.

All 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 11 study visits and will take part in the study for approximately 4.5 years.

Enrollment

550 estimated patients

Sex

All

Ages

65 to 84 years old

Volunteers

Accepts Healthy Volunteers

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 of age.

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

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

  4. Capable of giving personally signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion criteria

  1. Fertile male participants and WOCBP who are unwilling or unable to use an effective method of contraception from the signing of informed consent until at least 28 days after the last dose of study intervention.
  2. Serious chronic disorder, including history of metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, would make the participant inappropriate for entry into the study.
  3. Any contraindication to vaccination or vaccine components, including previous hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related components.
  4. Prior episode of CDI, confirmed by either laboratory test or diagnosis of pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
  5. Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
  6. Known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, leukocyte, lymphocyte, or immunoglobulin 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) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  8. Previous receipt of an investigational C difficile vaccine or C difficile mAb therapy.
  9. Receipt of blood product or immunoglobulin within 6 months before enrollment.
  10. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt throughout the study. Participants may not be enrolled if corticosteroids were administered within 28 days before study intervention administration.
  11. Participation in other studies involving investigational drugs, investigational vaccines, or investigational devices within 28 days prior to study entry through 12 months after the last dose of study intervention.
  12. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
  13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

550 participants in 12 patient groups

C. difficile vaccine formulation 1, 2-month schedule(Phase 1)
Experimental group
Description:
Novel vaccine formulation 1
Treatment:
Other: Saline Placebo.
Biological: C. difficile vaccine formulation 1.
C. difficile vaccine formulation 2, 2-month schedule (Phase 1)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine formulation 3, 2-month schedule (Phase 1)
Experimental group
Description:
Novel vaccine formulation 3
Treatment:
Biological: C. difficile vaccine formulation 3.
Other: Saline Placebo.
C. difficile vaccine formulation 1, 6-month schedule (Phase 1)
Experimental group
Description:
Novel vaccine formulation 1
Treatment:
Other: Saline Placebo.
Biological: C. difficile vaccine formulation 1.
C. difficile vaccine formulation 2, 6-month schedule (Phase 1)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine formulation 3, 6-month schedule (Phase 1)
Experimental group
Description:
Novel vaccine formulation 3
Treatment:
Biological: C. difficile vaccine formulation 3.
Other: Saline Placebo.
C. difficile vaccine (previously studied formulation) 6-months schedule (Phase 1)
Active Comparator group
Description:
Previously studied C. difficile vaccine formulation
Treatment:
Other: Saline Placebo.
Biological: C. difficile vaccine (previously studied formulation).
C difficile vaccine formulation 2. Schedule 1 with booster (Phase 2)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine formulation 2. Schedule 1 (Phase 2)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine formulation 2. Schedule 2 with booster (Phase 2)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine formulation 2. Schedule 2 (Phase 2)
Experimental group
Description:
Novel vaccine formulation 2
Treatment:
Biological: C. difficile vaccine formulation 2.
Other: Saline Placebo.
C. difficile vaccine (previously studied formulation) , 6-month schedule (Phase 2)
Active Comparator group
Description:
Previously studied C. difficile vaccine formulation
Treatment:
Other: Saline Placebo.
Biological: C. difficile vaccine (previously studied formulation).

Trial contacts and locations

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Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

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