To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults
- 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; and 50 through 64 years of age (Cohort 4 only) * 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. A booster stage for selected participants in Phase 2 will have participants receive active C. diff vaccine or placebo to examine immune persistence. The booster stage participants will attend at least 10 additional study visits and will take part in the study for 6 years. A newly added cohort will evaluate the safety and effects of active C. diff vaccine formulation in participants 50 through 64 years of age. Participants will receive C. diff vaccine or placebo and will attend at least 6 study visits over a period of 18 months.
- Short title
- To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults
- Official title
- A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND IMMUNOPERSISTENCE OF A CLOSTRIDIOIDES DIFFICILE VACCINE ADMINISTERED WITH NOVEL ADJUVANTS IN HEALTHY ADULTS
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2031-06-19
- First posted
- 2023-04-10
- Registry last updated
- 2026-04-29
- Primary completion date
- 2031-06-19
- Start date
- 2023-03-23
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pfizer
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05805826
- ClinicalTrials.gov ID
- NCT05805826
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Investigators, Outcome assessors
Phase 1: Percentage of participants reporting local reactions
Timeframe: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
Phase 1: Percentage of participants reporting systemic events
Timeframe: For 7 days after each vaccination
Vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain, and fever, as self-reported in electronic diaries
Phase 1: Percentage of participants reporting adverse events
Timeframe: From each vaccination through 1 month after vaccination
As elicited by investigational site staff
Phase 1: Percentage of participants reporting serious adverse events
Timeframe: From Dose 1 (Day 1) through 6 months after the last dose
As elicited by investigational site staff
Phase 1: Percentage of participants reporting medically attended adverse events
Timeframe: From Dose 1 (Day 1) through 6 months after the last dose of study intervention
As elicited by investigational site staff
Phase 1: Percentage of participants with abnormal hematology and chemistry laboratory values
Timeframe: 1 week after Dose 1 (Day 7) and 1 month after each dose (through Month 7)
As measured at the central laboratory
Phase 2: Percentage of participants reporting local reactions
Timeframe: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
Phase 2: Percentage of participants reporting systemic events
Timeframe: For 7 days after each vaccination
Vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain, and fever, as self-reported in electronic diaries
Phase 2: Percentage of participants reporting adverse events
Timeframe: From each dose of study intervention through 1 month after each dose of study intervention
As elicited by investigational site staff
Phase 2: Percentage of participants reporting adverse events
Timeframe: From the first dose of study intervention through 1 month after the last dose of study intervention
As elicited by investigational site staff
Phase 2: Percentage of participants reporting medically attended adverse events
Timeframe: From the first dose of study intervention through 6 months after the last dose of study intervention
As elicited by investigational site staff
Phase 2: Percentage of participants reporting serious adverse events
Timeframe: From the first dose of study intervention through 6 months after the last dose of study intervention
As elicited by investigational site staff
Phase 2: Geometric mean concentration (GMT) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Timeframe: 1 month after the last dose of study intervention
As measured at the central laboratory
Phase 2: Geometric mean ratio (GMR) of C. difficile toxin A- and toxin B- specific neutralizing antibodies
Timeframe: 1 month after the last dose of study intervention
As measured at the central laboratory
Phase 2: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Timeframe: From before vaccination to 1 month after the last dose
As measured at the central laboratory
Phase 2: Geometric mean ratio (GMR) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Timeframe: At Month 7 comparing data from ≥65 years of age to data from 50 through 64 years of age
As measured at the central laboratory
Phase 1: Percentage of participants reporting serious adverse events
Timeframe: From 6 months through 12 months after the last dose of study intervention
As elicited by investigational site
Phase 1: Percentage of participants reporting medically attended adverse events
Timeframe: From 6 months through 12 months after the last dose of study intervention
As elicited by investigational site
Phase 1: Geometric mean concentration (GMC) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Timeframe: 1 month after each dose, before the last dose, 6 months after the last dose, and 12 months after the last dose
As measured at the central laboratory
Phase 1: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Timeframe: From before Dose 1 (Day 1) to 1 month after each dose, and to 6 months and 12 months after the last dose
As measured at the central laboratory
Phase 2: Percentage of participants reporting medically attended adverse events
Timeframe: From 6 month through 12 months after the last dose of study intervention
As elicited by investigational site
Phase 2: Percentage of participants reporting serious adverse events
Timeframe: From 6 month through 12 months after the last dose
As elicited by investigational site
Phase 2: Geometric mean concentration (GMT) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Timeframe: At each planned post vaccination time point
As measured at the central laboratory
Phase 2: Geometric mean ratio (GMR) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Timeframe: At each planned post vaccination time point
As measured at the central laboratory
Phase 2: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Timeframe: From before vaccination to each planned post vaccination time point
As measured at the central laboratory
Phase 2: The percentage of participants with a greater than or equal to 4-fold rise in C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Timeframe: From before vaccination to each planned vaccination time point
As measured at the central laboratory
Phase 2: Geometric mean concentration (GMT) of C. difficile toxin A- and toxin B- specific neutralizing antibodies
Timeframe: At each planned persistence time point
As measured at the central laboratory
Phase 2: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B- specific neutralizing antibodies
Timeframe: From before vaccination to each planned persistence time point
As measured at the central laboratory
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 50 Years
- Healthy volunteers
- Yes
-
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; Cohort 4 Participants 50 through 64 years of age.
-
Healthy participants as determined by medical history, clinical assessment, and the judgment of the investigator.
-
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
-
Capable of giving personally signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
- 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.
- 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.
- Any contraindication to vaccination or vaccine components, including previous hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related components.
- Prior episode of CDI, confirmed by either laboratory test or diagnosis of pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
- Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
- 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.
- 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.
- Previous receipt of an investigational C difficile vaccine or C difficile mAb therapy.
- Receipt of blood product or immunoglobulin within 6 months before enrollment.
- 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.
- 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.
- Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
- 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.
- HOPE Research InstitutePhoenix, United States
- Anaheim Clinical Trials, LLCAnaheim, United States
- Alliance for Multispecialty Research, LLCDoral, United States
- Indago Research & Health Center, IncHialeah, United States
- Research Centers of AmericaHollywood, United States
- Miami Clinical ResearchMiami, United States
- New Horizon Research CenterMiami, United States
- Charisma Medical and Research CenterMiami Lakes, United States
- Pembroke Pines, United States
- DBC Research USAPembroke Pines, United States
- BRCR Medical Center Inc.Plantation, United States
- Clinical Research Trials of FloridaTampa, United States
- Great Lakes Clinical Trials - RavenswoodChicago, United States
- Alliance for Multispecialty Research, LLCWichita, United States
- Prism Research LLC dba Nucleus NetworkSaint Paul, United States
- Washington University School of MedicineSt Louis, United States
- Washington UniversitySt Louis, United States
- NYU Langone HealthNew York, United States
- Rochester Clinical Research, Inc.Rochester, United States
- Qcare Site Services Inc. d/b/a AvacareDurham, United States
- CTI Clinical Research CenterCincinnati, United States
- Benchmark ResearchAustin, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomball, United States
- Related resource (pmiform.com)
Other registry identifiers
- NCT05805826