Clinical Trial

Responses to Vaccination with Shigella Vaccine

Study Description

Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine

The purpose of this study is to determine whether SF2a-TT15 (a monovalent synthetic carbohydrate-based conjugate Shigella vaccine) is safe and effective in the prevention of Shigella infection.

Location

Locations Selected Location

Methods

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

Biological - SF2a-TT15 Shigella Vaccine

0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.

Placebo

0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.

Biological - S. flexneri 2a strain 2457T Challenge Agent

Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.

Additional Information

Official Study Title

Phase 2b Study of the Safety, Immunogenicity, and Efficacy of a Monovalent Synthetic Carbohydrate-based Conjugate Vaccine (SF2a-TT15) for Protection Against Shigella Flexneri 2a Experimental Infection

Clinical Trial ID

NCT04078022

ParticipAid ID

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