PaxVax is seeking approval to conduct a clinical trial of a GM live bacterial vaccine against cholera. Once underway the trial is expected to be completed within one year, with trial sites selected from local government areas (LGAs) in Queensland, South Australia, Victoria and Western Australia. The trial will involve the inoculation of approximately 1000 children and adults. The applicant has proposed a number of control measures to restrict the spread and persistence of the GM vaccine and its introduced genetic material.
PaxVax has indicated that a Clinical Trial Notification will be submitted to the Therapeutic Goods Administration, and that they will be applying to Department of Agriculture for a permit to import the vaccines.
In the interim, you can obtain a copy of the application by contacting my Office (contact details below; please quote application DIR 126). As the application is quite lengthy, you may prefer to view a summary of the application, which is posted on our website along with this document (under ‘What’s New’).
If you have any questions or would like to receive a hard copy of the application summary, please contact the OGTR.
Dr Joe SmithGene Technology Regulator11 November 2013