Production of candidate H5 influenza DNA plasmid based vaccine for human clinical trials has been completed in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials. The vaccine has been evaluated in healthy human volunteers in two Phase I clinical trials this (VRC 304 and VRC 305). If these trials demonstrate safety and immunogenicity of this vaccine in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at large scale.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Intramural Research (Z01)
Project #
1Z01AI005086-02
Application #
7592434
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2007
Total Cost
$3,180,682
Indirect Cost
City
State
Country
United States
Zip Code
Stadinski, Brian D; Zhang, Li; Crawford, Frances et al. (2010) Diabetogenic T cells recognize insulin bound to IAg7 in an unexpected, weakly binding register. Proc Natl Acad Sci U S A 107:10978-83