The objective of this single-blind, first in human study is to evaluate safety, reactogenicity and immunogenicity of the vaccine at two doses, with or without adjuvant, in 40 healthy naive volunteers. Data from the study are anticipated by the end of 2010.
A conjugate vaccine, used to immunize against serious bacterial infections, is created by linking a sugar antigen to a carrier protein molecule. The current process to obtain such a structure is often very complex, unreliable and expensive.
GlycoVaxyn’s shigella vaccine consists of a polysaccharide of Shigella dysenteriae O1 conjugated to a protein carrier. It is produced using GlycoVaxyn’s new technology that allows the synthesis of these complex immunogenic bioconjugates via a biological process in E Coli, which makes the production more effective and controlled.
GlycoVaxyn is also developing a multivalent vaccine against shigella flexneri serotypes and shigella sonnei.
Philippe Dro, CEO of GlycoVaxyn, said: “The start of clinical trials with our first candidate marks a major milestone for GlycoVaxyn and will serve as validation of our bioconjugation platform. There is a large demand for a shigella vaccine, particularly in emerging countries. Our proprietary technology allows us not only to develop and produce a multivalent shigella vaccine but also bioconjugate vaccines against various diseases where no prevention or treatment is available.”