NCT01644565

Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (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 chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.

Detailed description

The purpose of the study is to evaluate the safety and immunogenicity of dsc14cfaEsCTA2/LTB5 (Chimera) and dscCfaE administered with and without LTR192G by intradermal (ID) immunization and to gather additional data on the administration of dsCfaE and LTR192G via transcutaneous immunization (TCI) route. If vaccines are found to be safe and adequately immunogenic in humans, a down-selection would occur and a phase 2b vaccination/challenge study would be undertaken to further evaluate vaccine safety and allow a preliminary assessment of efficacy of one of these candidates by the ID or TCI route. 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 dsc14CfaE-sCTA2/LTB5
BIOLOGICAL	Recombinant fimbrial adhesin dscCfaE
BIOLOGICAL	Modified E. coli heat labile enterotoxin LTR192G

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-06-01
• Completion: 2015-06-01
• First posted: 2012-07-19
• Last updated: 2021-02-12
• Results posted: 2019-07-08

Locations

1 site across 1 country: United States