Abstract

Production of candidate a trivalent equine encephalitits vaccine containing VLPs for western eastern and venevuelen EEV for human clinical trials will be done in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials. This required development of production methods based upon novel cell substrates and 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. Scale-up of a VLP-based chikungunya vaccine is progressing towards GMP production for expanded clinical testing.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Production Facilities Intramural Research (ZIB)
Project #
1ZIBAI005110-07
Application #
9161786
Study Section
Project Start
Project End
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Budget End
Support Year
7
Fiscal Year
2015
Total Cost
Indirect Cost

  Institution

Name
Niaid Extramural Activities
Department
Type
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