Breadcrumbs

DIR 184

Clinical trial with a genetically modified human adenovirus COVID-19 vaccine

Licence details

Licence number:
DIR 184
Licence status:
Current
Category:
Medical
Release:
Limited and controlled
Organisation:

Avance Clinical Pty Ltd

Parent organism:

Adenovirus

Modified trait:

Vaccine - altered antigen expression; Vaccine – replication incompetent

Licence issue date:
Description:

Avance Clinical Pty Ltd is conducting a clinical trial of a COVID-19 vaccine in Australia.

The trial assesses intranasal administration of a GM vaccine for COVID-19. This is different to the intramuscular administration of COVID-19 vaccines currently in use.

The GM vaccine is imported and delivered directly to trial sites. Up to 1,000 healthy participants will take part in the trial.

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.

 

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.