DIR 185

Clinical trial with a genetically modified Bordetella pertussis for the prevention of whooping cough

Licence details

Licence number:
DIR 185
Licence status:
Limited and controlled

PPD Australia Pty Ltd

Parent organism:

Bordetella pertussis

Modified trait:

Vaccine - attenuated

Licence issue date:

This licence authorises Novotech (Australia) Pty Ltd to conduct a clinical trial of a genetically modified (GM) pertussis vaccine for the prevention of whooping cough in Australia.

The trial assesses the intranasal administration of a GM vaccine for pertussis. This is different to the intramuscular administration of acellular pertussis vaccines currently in use.

The GM vaccine will be imported and transported to a secure third-party storage site prior to transport to clinical trial sites in Australia. Up to 300 participants will take part in the trial in Australia.

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.

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

This licence was transferred to PPD Australia Pty Ltd on 7 January 2022.

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


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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