NCT01382095

Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea

A Phase 1 Dose-Escalating Study of dscCfaE, Co-Administered With and Without LTR192G, by Transcutaneous Immunization (TCI) in Healthy Adult U.S. Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.

Detailed description

The purpose of the study is to determine if immunization with dscCfaE with or without a modified E. coli heat labile enterotoxin, LTR192G, is safe and immunogenic when administered transcutaneously using a skin wet-patch. If the vaccine is found safe and adequately immunogenic in humans, a phase 2b vaccination/challenge study would be undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy. With favorable evidence for safety, immunogenicity, efficacy, complemented by advances in standard methodology to combine multiple adhesins with an appropriate LT enterotoxoid form, a multivalent vaccine would be constructed and evaluated for further clinical development.

Conditions

• Escherichia Coli Infection

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant fimbrial adhesin dscCfaE	10 ug on study days 0, 21 and 42
BIOLOGICAL	Recombinant fimbrial adhesin dscCfaE	50 ug on study days 0, 21 and 42
BIOLOGICAL	Recombinant fimbrial adhesin dscCfaE	250 ug on study days 0, 21 and 42
BIOLOGICAL	Modified E. coli heat labile enterotoxin LTR192G	50 ug on study days 0, 21 and 42

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-08-01
• Completion: 2013-04-01
• First posted: 2011-06-27
• Last updated: 2015-04-27

Locations

1 site across 1 country: United States