NCT03981952

Salmonella Conjugates CVD 1000: Study of Responses to Vaccination With Trivalent Invasive Salmonella Disease Vaccine

Phase 1 Randomized, Placebo-Controlled, Dose-Escalation Study of the Safety, Reactogenicity, and Immunogenicity of Trivalent (S. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine Against Invasive Salmonella Disease Administered Parenterally to Healthy U.S. Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo-controlled dose-escalation 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.

Conditions

• Risk Reduction

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent Invasive Salmonella Disease Vaccine (6.25 µg)	6.25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
BIOLOGICAL	Trivalent Invasive Salmonella Disease Vaccine (12 µg)	12 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
BIOLOGICAL	Trivalent Invasive Salmonella Disease Vaccine (25 µg)	25 µg of the conjugate vaccine is administered via one intramuscular injection into the deltoid muscle on Study Day 1.
BIOLOGICAL	Trivalent Invasive Salmonella Disease Vaccine (highest, well-tolerated dose among Cohorts A-C)	The highest, well-tolerated dose of the conjugate vaccine among Cohorts A-C is administered via one or two intramuscular injection(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).
OTHER	Placebo	0.5 mL of buffer and preservative is administered via one or two intramuscular injections(s) into the deltoid muscle on Study Day 1 (and 29 if two doses are given).

Timeline

• Start date: 2019-10-28
• Primary completion: 2021-05-07
• Completion: 2021-05-07
• First posted: 2019-06-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study