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| Grant Number: | 2R44AI045227-02A2 |
| PI Name: | KENNEY, RICHARD T. |
| PI Email: | rkenney@iomai.com |
| PI Title: | |
| Project Title: | Transcutaneous Immunization for Enteric Vaccine |
Abstract: DESCRIPTION (provided by applicant): Having previously demonstrated immune responses in human subjects to heat labile enterotoxin of E coli and the colonization factor CS6, when administered via the transcutaneous route, this application proposes a clinical plan to determine if the observed immune responses are relevant, functional, and protective. First, a preliminary Phase 2 clinical study is proposed to firmly establish the antigen/adjuvant dose required to achieve a consistent and robust immune response. This will be followed by a second study in which volunteers will be challenged with a live E coli organism that expresses both LT and CS6. A successful demonstration of efficacy will lead to further development of an ETEC vaccine with broader coverage.
Thesaurus Terms:
Escherichia coli, antigen antibody reaction, cholera vaccine, drug screening /evaluation, enterotoxin, immunization, transdermal drug delivery, vaccine development
active immunization, cholera toxin, infection
clinical research, human subject, laboratory mouse
| Institution: | IOMAI CORPORATION |
| 20 FIRSTFIELD RD, STE 250 | |
| GAITHERSBURG, MD 20878 | |
| Fiscal Year: | 2002 |
| Department: | |
| Project Start: | 30-SEP-1999 |
| Project End: | 31-AUG-2003 |
| ICD: | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES |
| IRG: | ZRG1 |