A Phase 1 Dose Escalating Study of Two Enterotoxigenic Escherichia Coli Prototype Adhesin-based Vaccines With or Without Modified Heat-labile Enterotoxin by Intradermal or Transcutaneous Immunization

NCT01644565 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1
Status	COMPLETED
Enrolment	57
Start date	2012-08
Completion	2015-06

Conditions

• Escherichia Coli Infection

Interventions

• Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5
• Recombinant fimbrial adhesin dscCfaE
• Modified E. coli heat labile enterotoxin LTR192G

Primary outcomes

• Safety - Occurrence of Adverse Events — 1 year
  Occurrence of related and unrelated to vaccine AE's

Countries

United States