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

Summary

This trial is testing a new vaccine to prevent serious Salmonella infections. It aims to see if the vaccine is safe and how well it helps the immune system fight the bacteria. The study focuses on people at risk of severe Salmonella disease. The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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