Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation for Risk Reduction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pharmaron, Baltimore, MD
Risk Reduction
Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a randomized, placebo-controlled interventional study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.

Treatment Effectiveness

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: approximately six months

Approximately six months
Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs)
Frequency and Severity of Unsolicited AEs and Serious Adverse Events (SAEs)
approximately six months
Proportion of Responders

Trial Safety

Trial Design

4 Treatment Groups

Group A: Full-Strength Formulation
1 of 4
Group C: Dilutional Half-Strength Formulation
1 of 4
Group B: Half-Strength Formulation
1 of 4
Group D: Placebo
1 of 4
Experimental Treatment
Non-Treatment Group

80 Total Participants · 4 Treatment Groups

Primary Treatment: Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation · Has Placebo Group · Phase 1

Group A: Full-Strength Formulation
Biological
Experimental Group · 1 Intervention: Trivalent Salmonella Conjugate Vaccine (TSCV) Full-Strength Formulation · Intervention Types: Biological
Group C: Dilutional Half-Strength Formulation
Biological
Experimental Group · 1 Intervention: Trivalent Salmonella Conjugate Vaccine (TSCV) Dilutional Half-Strength Formulation · Intervention Types: Biological
Group B: Half-Strength Formulation
Biological
Experimental Group · 1 Intervention: Trivalent Salmonella Conjugate Vaccine (TSCV) Half-Strength Formulation · Intervention Types: Biological
Group D: Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately six months
Closest Location: Pharmaron · Baltimore, MD
Photo of Baltimore 1Photo of Baltimore 2Photo of Baltimore 3
2018First Recorded Clinical Trial
1 TrialsResearching Risk Reduction
7 CompletedClinical Trials

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
594 Previous Clinical Trials
332,422 Total Patients Enrolled
2 Trials studying Risk Reduction
246 Patients Enrolled for Risk Reduction
Myron M Levine, MD, DTPHStudy DirectorUniversity of Maryland School of Medicine
2 Previous Clinical Trials
4,284 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of child-bearing potential and must agree to acceptable birth control.
You are aged 18 - 49 years, inclusive.
You are willing to participate in another clinical trial at any time during the study period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.