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DIR 195

Trial of a genetically modified vaccine against devil facial tumour disease in Tasmanian devils

Licence details

Licence number:
DIR 195
Licence status:
Current
Category:
Veterinary
Release:
Limited and controlled
Organisation:

University of Tasmania

Parent organism:

Human adenovirus

Modified trait:

Vaccine - attenuated

Licence issue date:
Description:

This licence allows the trial, under limited and controlled conditions, of a genetically modified (GM) vaccine for the prevention and/or treatment of devil facial tumour disease (DFTD) in Tasmanian devils.

DFTD is a transmissible cancer that affects Tasmanian devils. It is transmitted from one devil to another by biting and leads to the development of tumours on the face or inside the mouth of affected animals. This disease has caused a significant decline in the wild population of Tasmanian devils over the last decades.

The GM vaccine is based on an adenoviral vector. It has been modified by the deletion of genes so that it cannot multiply or cause disease. Additionally, the GM vaccine contains genes to produce proteins designed to induce an immune response against devil facial tumour cells. The GM vaccine is expected to protect devils against future exposure to DFTD.

The trial will be conducted within contained trial sites in Tasmania. Up to 22 Tasmanian devils will receive the GM vaccine.

The RARMP concluded that the trial poses low to moderate risks to people and negligible risks to the environment. However, as this is a 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.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:

Documents

Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

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.

Risk assessment and risk management plan - full version

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.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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