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 will necessitate developing 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.
|Shytuhina, Anastasija; Pristatsky, Pavlo; He, Jian et al. (2014) Development and application of a reversed-phase high-performance liquid chromatographic method for quantitation and characterization of a Chikungunya virus-like particle vaccine. J Chromatogr A 1364:192-7|
|Chang, Lee-Jah; Dowd, Kimberly A; Mendoza, Floreliz H et al. (2014) Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet :|