Development and Production of alphavirus vaccines

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications, trials & patents

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.