GMO dealings

DIR 214

Trial of a genetically modified (GM) vaccine for the prevention of respiratory disease in horses.

Licence details

Licence number:
DIR 214
Licence status:
Current
Category:
Veterinary
Release:
Limited and controlled
Organisation:

The University of Queensland

Parent organism:

Human Adenovirus 5 (HAdV5)

Modified trait:

Deleted genes:

  • Viral early-transcribed region 1 (E1) - to render virus unable to replicate.
  • Viral early-transcribed region 3 (E3) - to improve the transgene carrying capacity of the viral vector and increase the host immune response to the vector.

Introduced gene: 
Virulence-associated protein A (VapA) from Rhodococcus equi - Expression of the VapA

Licence issue date:
Description:

This licence allows The University of Queensland to conduct a trial of a genetically modified (GM) vaccine for prevention of respiratory disease in horses in Australia.

Up to 10 horses will be administered with the vaccine over 5 years.

Administration of the vaccine will occur in a secure facility within the Queensland Animal Science Precinct at the University of Queensland’s Gatton campus, Queensland.

The RARMP concluded that the trial poses negligible risks to people or 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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