Clinical Trial: Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Number of Adverse Events [ Time Frame: 1 year ]
- Number of seroconversion events [ Time Frame: day 0, 21, 42, 56, 70 ]The primary immunology outcome is seroconversion to LT and dscCfaE will be defined as a > 4-fold increase in endpoint titer between pre-and post-vaccination samples
Original Primary Outcome: Safety Based on Number of Adverse Events [ Time Frame: Study Days 0 -180 ]
Current Secondary Outcome: Number of positive IgA-ASC response [ Time Frame: Day 0, 21,42, 56, 70 ]
Original Secondary Outcome: Immunogenicity Based on Serum and Mucosal Responses [ Time Frame: Study Days 0 - 70 ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: July 11, 2012
Date Started: August 2012
Date Completion: November 2017
Last Updated: October 30, 2015
Last Verified: October 2015