C. difficile vaccine (previously studied formulation).
BiologicalToxoid based Clostridioides difficile vaccine (previously studied formulation) given as an intramuscular injection
NCT Number: NCT05805826
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.
This study is active but is not currently recruiting participants.
Notify Me50 year and older
All sexes
Interventional
Phase 1 / Phase 2
HOPE Research Institute, Phoenix, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
Toxoid based Clostridioides difficile vaccine (previously studied formulation) given as an intramuscular injection
C. difficile vaccine formulation 1 given as an intramuscular injection
C. difficile vaccine formulation 2 given as an intramuscular injection
C. difficile vaccine formulation 3 given as an intramuscular injection
0.9% sodium chloride solution given as an intramuscular injection
Time frame: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
Time frame: 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
Time frame: From each vaccination through 1 month after vaccination
As elicited by investigational site staff
Time frame: From Dose 1 (Day 1) through 6 months after the last dose
As elicited by investigational site staff
Time frame: From Dose 1 (Day 1) through 6 months after the last dose of study intervention
As elicited by investigational site staff
Time frame: 1 week after Dose 1 (Day 7) and 1 month after each dose (through Month 7)
As measured at the central laboratory
Time frame: For 7 days after each vaccination
Injection site pain, redness, and swelling as self-reported in electronic diaries
Time frame: 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
Time frame: From each dose of study intervention through 1 month after each dose of study intervention
As elicited by investigational site staff
Time frame: From the first dose of study intervention through 1 month after the last dose of study intervention
As elicited by investigational site staff
Time frame: From the first dose of study intervention through 6 months after the last dose of study intervention
As elicited by investigational site staff
Time frame: From the first dose of study intervention through 6 months after the last dose of study intervention
As elicited by investigational site staff
Time frame: 1 month after the last dose of study intervention
As measured at the central laboratory
Time frame: 1 month after the last dose of study intervention
As measured at the central laboratory
Time frame: From before vaccination to 1 month after the last dose
As measured at the central laboratory
Time frame: 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
Time frame: From 6 months through 12 months after the last dose of study intervention
As elicited by investigational site
Time frame: From 6 months through 12 months after the last dose of study intervention
As elicited by investigational site
Time frame: 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
Time frame: 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
Time frame: From 6 month through 12 months after the last dose of study intervention
As elicited by investigational site
Time frame: From 6 month through 12 months after the last dose
As elicited by investigational site
Time frame: At each planned post vaccination time point
As measured at the central laboratory
Time frame: At each planned post vaccination time point
As measured at the central laboratory
Time frame: From before vaccination to each planned post vaccination time point
As measured at the central laboratory
Time frame: From before vaccination to each planned vaccination time point
As measured at the central laboratory
Time frame: At each planned persistence time point
As measured at the central laboratory
Time frame: From before vaccination to each planned persistence time point
As measured at the central laboratory
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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