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Cancer Vaccine
Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation for Risk Reduction
Phase 1
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately six months
Awards & highlights
Study Summary
This trial will test a new vaccine for Salmonella, testing how well it works and if it is safe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs)
Frequency and Severity of Unsolicited AEs and Serious Adverse Events (SAEs)
Proportion of Responders
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group C: Dilutional Half-Strength FormulationExperimental Treatment1 Intervention
Individuals receive one dose of dilutional half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Group II: Group B: Half-Strength FormulationExperimental Treatment1 Intervention
Individuals receive one dose of half-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Group III: Group A: Full-Strength FormulationExperimental Treatment1 Intervention
Individuals receive one dose of full-strength Trivalent Salmonella Conjugate Vaccine (TSCV). Subsequent blood samples are taken for safety and immunological testing.
Group IV: Group D: PlaceboPlacebo Group1 Intervention
Individuals receive one dose of placebo. Subsequent blood samples are taken for safety and immunological testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation
2022
Completed Phase 1
~90
Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation
2022
Completed Phase 1
~90
Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation
2022
Completed Phase 1
~90
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
692 Previous Clinical Trials
376,782 Total Patients Enrolled
2 Trials studying Risk Reduction
246 Patients Enrolled for Risk Reduction
Myron M Levine, MD, DTPHStudy DirectorUniversity of Maryland, Baltimore
2 Previous Clinical Trials
4,284 Total Patients Enrolled
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