Clinical Trial

Salmonella Vaccination

Study Description

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

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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).

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).

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03981952

ParticipAid ID

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