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NCT05805826 · ClinicalTrials.gov registry record · Phase 1
To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults
A Phase 1 study of Clostridoides Difficile Associated Disease, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 936
- Enrollment target
- 20
- Study locations
NCT05805826 is a Phase 1 study of Clostridoides Difficile Associated Disease that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 936 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT05805826, a Phase 1 study of Clostridoides Difficile Associated Disease, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 936 participants
- Enrollment target
- 20
- Study locations
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; 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 a
Conditions Studied
Interventions
- BIOLOGICAL C. difficile vaccine (previously studied formulation).
- BIOLOGICAL C. difficile vaccine formulation 1.
- BIOLOGICAL C. difficile vaccine formulation 2.
- BIOLOGICAL C. difficile vaccine formulation 3.
- OTHER Saline Placebo.
Study Locations (20)
Florida
- Alliance for Multispecialty Research, LLC - Doral
- Indago Research & Health Center, Inc - Hialeah
- Research Centers of America - Hollywood
- Miami Clinical Research - Miami
- New Horizon Research Center - Miami
- Charisma Medical and Research Center - Miami Lakes
- Private Practice - Dr. Hector Fabregas - Pembroke Pines
- DBC Research USA - Pembroke Pines
- BRCR Medical Center Inc. - Plantation
- Clinical Research Trials of Florida - Tampa
Missouri
- Washington University School of Medicine - St Louis
- Washington University - St Louis
New York
- NYU Langone Health - New York
- Rochester Clinical Research, LLC - Rochester
Arizona
- HOPE Research Institute - Phoenix
California
- Anaheim Clinical Trials, LLC - Anaheim
Illinois
- Great Lakes Clinical Trials - Ravenswood - Chicago
Kansas
- Alliance for Multispecialty Research, LLC - Wichita
Minnesota
- Prism Research LLC dba Nucleus Network - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 936 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2031-06-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05805826
The ClinicalTrials.gov registry entry for NCT05805826 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 936 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clostridoides Difficile Associated Disease appearing as the primary indexed condition, and to 5 interventions - of which C. difficile vaccine (previously studied formulation). is the first listed.
NCT05805826 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT05805826 about?
NCT05805826 is a clinical study titled "To Understand the Safety and Effects of a C. Difficile Vaccine With New Adds-Ons That Will Be Given to Healthy Adults". 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 ...
What is the current status of trial NCT05805826?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 936 participants. The study started on 2023-03-23. Estimated completion is 2031-06-19.
What conditions does trial NCT05805826 study?
This clinical trial studies the following conditions: Clostridoides Difficile Associated Disease.
What interventions are being tested in trial NCT05805826?
The interventions under investigation include: C. difficile vaccine (previously studied formulation). (BIOLOGICAL), C. difficile vaccine formulation 1. (BIOLOGICAL), C. difficile vaccine formulation 2. (BIOLOGICAL), C. difficile vaccine formulation 3. (BIOLOGICAL), Saline Placebo. (OTHER).
Who is sponsoring clinical trial NCT05805826?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05805826 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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