NCT05805826

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

A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND IMMUNOPERSISTENCE OF A CLOSTRIDIOIDES DIFFICILE VACCINE ADMINISTERED WITH NOVEL ADJUVANTS IN HEALTHY ADULTS

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 936 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clostridoides Difficile Associated Disease

Interventions

Type	Name	Description
BIOLOGICAL	C. difficile vaccine (previously studied formulation).	Toxoid based Clostridioides difficile vaccine (previously studied formulation) given as an intramuscular injection
BIOLOGICAL	C. difficile vaccine formulation 1.	C. difficile vaccine formulation 1 given as an intramuscular injection
BIOLOGICAL	C. difficile vaccine formulation 2.	C. difficile vaccine formulation 2 given as an intramuscular injection
BIOLOGICAL	C. difficile vaccine formulation 3.	C. difficile vaccine formulation 3 given as an intramuscular injection
OTHER	Saline Placebo.	0.9% sodium chloride solution given as an intramuscular injection

Timeline

• Start date: 2023-03-23
• Primary completion: 2031-06-19
• Completion: 2031-06-19
• First posted: 2023-04-10
• Last updated: 2026-01-27

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study