drugset
drugset / Trial / NCT01644565

Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea

NCT01644565 ↗

Phase 1 Completed 57 enrolled U.S. Army Medical Research and Development Command
RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.

Timeline

Start
2012-08
Primary completion
2014-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Modified E. coli heat labile enterotoxin LTR192G Protein / enzyme biologic 50 ng Intramuscular
Subject Modified E. coli heat labile enterotoxin LTR192G Protein / enzyme biologic 100 ng Intramuscular
Subject Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Protein / enzyme biologic 2.6 ug Intramuscular
Subject Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5 Protein / enzyme biologic 12.9 ug Intramuscular
Subject Recombinant fimbrial adhesin dscCfaE Protein / enzyme biologic 1 ug Intramuscular
Subject Recombinant fimbrial adhesin dscCfaE Protein / enzyme biologic 5 ug Intramuscular
Subject Recombinant fimbrial adhesin dscCfaE Protein / enzyme biologic 25 ug Intramuscular
Subject Recombinant fimbrial adhesin dscCfaE Protein / enzyme biologic 1250 ug Intramuscular

Indications

escherichia coli infection