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Cancer Vaccine

C. difficile Vaccine for C. difficile Infection

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Previous receipt of an investigational C difficile vaccine or C difficile mAb therapy.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 month through 12 months after the last dose

Summary

This trial is studying the safety & antibody response of a vaccine to prevent severe diarrhea from a germ called C. diff. Healthy adults of ages 50-84 are needed for the study. They will receive active vaccine/placebo, and be followed for 4.5 years.

Who is the study for?
Healthy adults aged 65-84 for Phase 1, and 50-84 for Phase 2, who've never had a C. diff infection or received any C. diff vaccine or therapy. Participants must be able to follow the study plan and give informed consent. Exclusions include those on immunosuppressive therapy, involved in other investigational studies, with certain medical conditions or history of severe allergies to vaccines.
What is being tested?
The trial is testing three new formulations of a C. difficile vaccine against one previously studied formulation and a saline placebo to see if they're safe and can help the body produce antibodies against C. diff infection. The study has two phases: Phase 1 tests different dosing schedules; based on these results, one or two formulations will advance to Phase 2.
What are the potential side effects?
While specific side effects are not listed here, common side effects from vaccines may include pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never received an experimental vaccine or antibody therapy for C. difficile.
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I am not on immunosuppressive therapy or have taken corticosteroids in the last 28 days.
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I have had a confirmed case of C. diff infection before.
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I have a condition that weakens my immune system.
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I do not have a bleeding disorder or take blood thinners that prevent muscle injections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months through 12 months after the last dose of study intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months through 12 months after the last dose of study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Percentage of participants reporting adverse events
Phase 1: Percentage of participants reporting local reactions
Phase 1: Percentage of participants reporting systemic events
+5 more
Secondary study objectives
Phase 1: Geometric mean concentration (GMC) of C. difficile toxin A- and toxin B-specific neutralizing antibodies
Phase 1: Geometric mean fold-rise (GMFR) of C. difficile toxin A- and toxin B-specific neutralizing antibody concentrations
Phase 1: Percentage of participants reporting medically attended adverse events
+9 more

Trial Design

15Treatment groups
Experimental Treatment
Active Control
Group I: C. difficile vaccine formulation 3, Schedule 4 (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 3
Group II: C. difficile vaccine formulation 3, Schedule 2 (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 3
Group III: C. difficile vaccine formulation 2, Schedule 7 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group IV: C. difficile vaccine formulation 2, Schedule 6 (Phase 2)Experimental Treatment1 Intervention
Novel vaccine formulation 2
Group V: C. difficile vaccine formulation 2, Schedule 5 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VI: C. difficile vaccine formulation 2, Schedule 4, (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VII: C. difficile vaccine formulation 2, Schedule 4 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group VIII: C. difficile vaccine formulation 2, Schedule 4 (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group IX: C. difficile vaccine formulation 2, Schedule 3 (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group X: C. difficile vaccine formulation 2, Schedule 1, (Phase 2)Experimental Treatment1 Intervention
Novel vaccine formulation 2
Group XI: C. difficile vaccine formulation 1, Schedule 4 (Phase 1)Experimental Treatment1 Intervention
Novel vaccine formulation 1
Group XII: C. difficile vaccine formulation 1, Schedule 2 (Phase 1)Experimental Treatment2 Interventions
Novel vaccine formulation 1
Group XIII: C difficile vaccine formulation 2, Schedule 1 (Phase 2)Experimental Treatment2 Interventions
Novel vaccine formulation 2
Group XIV: C. difficile vaccine (previously studied formulation) Schedule 1 (Phase 1)Active Control2 Interventions
Previously studied C. difficile vaccine formulation
Group XV: C. difficile vaccine (previously studied formulation) , Schedule 1 (Phase 2)Active Control2 Interventions
Previously studied C. difficile vaccine formulation

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,716,493 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,349 Total Patients Enrolled

Media Library

C. difficile vaccine formulation 1 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05805826 — Phase 1 & 2
C. difficile Infection Research Study Groups: C. difficile vaccine formulation 2, Schedule 1, (Phase 2), C. difficile vaccine formulation 2, Schedule 4, (Phase 2), C. difficile vaccine formulation 1, Schedule 2 (Phase 1), C. difficile vaccine formulation 2, Schedule 3 (Phase 1), C. difficile vaccine formulation 3, Schedule 2 (Phase 1), C. difficile vaccine formulation 1, Schedule 4 (Phase 1), C. difficile vaccine formulation 2, Schedule 4 (Phase 1), C. difficile vaccine formulation 3, Schedule 4 (Phase 1), C. difficile vaccine (previously studied formulation) Schedule 1 (Phase 1), C difficile vaccine formulation 2, Schedule 1 (Phase 2), C. difficile vaccine formulation 2, Schedule 4 (Phase 2), C. difficile vaccine formulation 2, Schedule 5 (Phase 2), C. difficile vaccine formulation 2, Schedule 6 (Phase 2), C. difficile vaccine (previously studied formulation) , Schedule 1 (Phase 2), C. difficile vaccine formulation 2, Schedule 7 (Phase 2)
C. difficile Infection Clinical Trial 2023: C. difficile vaccine formulation 1 Highlights & Side Effects. Trial Name: NCT05805826 — Phase 1 & 2
C. difficile vaccine formulation 1 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805826 — Phase 1 & 2
~456 spots leftby Aug 2028
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