The Westmead Institute for Medical Research
Human therapeutic – reduce antibiotic resistance in gut bacteria
The Westmead Institute for Medical Research is conducting a clinical trial with genetically modified (GM) E.coli to reduce antibiotic resistance.
The trial aims to treat 100 participants over 5 years. To be eligible, participants need to have bacteria carrying a specific type of antibiotic resistance. They will be treated under controlled conditions at Westmead Hospital in Sydney.
The RARMP concluded that the clinical trial poses negligible risks to people or the environment. However, as this is a clinical trial under limited and controlled conditions, licence conditions have been imposed to:
- restrict when and where the trial can take place
- limit the size of the trial
- restrict the spread and persistence of the GM vaccine.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.