GVXN SD133 |
Study to Evaluate Safety, Reactogenicity and Immunogenicity of a Vaccine Against Shigella dysenteriae (GVXN SD133)
The Pharmaceutical Medicine Unit (PMU) was in charge of the monitoring of this Phase I clinical study investigating a novel vaccine candidate (GVXN SD133) against Shigella dysenteriae, which is a cause of bacterial dysentery (a serious intestinal infection). GVXN SD133 has been developed by the Swiss biotechnology company GlycoVaxyn AG.
GVXN SD133 is the first product from GlycoVaxyn to enter clinical evaluation and is created by linking a sugar antigen to a carrier protein molecule using GlycoVaxyn’s novel technology. This in-vivo glycosylation platform allows the synthesis of these complex conjugate vaccines in bacteria, and therefore makes the process more effective and controlled than using conventional, chemical production methods.
The Principal Investigator for this clinical study was Prof. Dr. Christoph Hatz, Head of the Division of Communicable Diseases at the Institute of Social and Preventive Medicine, University of Zurich, Switzerland.
The objective of this single-blind, first in human study was to evaluate the safety, reactogenicity and immunogenicity of the vaccine at two dose levels, with or without adjuvant. Two injections were given 60 days apart to 40 healthy naïve volunteers (male and female).
Clinical and immunological data were available at the end of 2010. The study met the primary and secondary endpoints: demonstration of safety and immunogenicity. No significant adverse reactions were observed at any of the vaccine dose levels. In addition, the results showed that the majority of the volunteers achieved robust IgG as well as IgA antibody responses.