common.study.topics.clinical

Responses to Vaccination with Shigella Vaccine

common.study.values.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.

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participant.ui.study.affiliations-map.online-study.header-virtual

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No pharmaceutical medication involved common.study.methods.has-drugs-no
Patients and healthy individuals accepted common.study.methods.is-healthy-no

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.

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participant.views.study.view.scientific-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

common.study.values.clinical-trial-id

NCT04078022

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