Invitation to comment on a clinical trial
of genetically modified (GM) influenza vaccine

The Gene Technology Regulator is assessing an application from Clinical Network Services (CNS) Pty Ltd to conduct a clinical trial, under limited and controlled conditions, of a GM vaccine for the protection of people against Influenza virus infection. The proposed trial would be conducted at up to four clinical facilities, which will be located in Adelaide, Brisbane, Melbourne, Perth or Sydney. Up to 240 trial participants would be vaccinated in the trial over a three year period.

The Regulator has prepared a Risk Assessment and Risk Management Plan (RARMP) for this application and welcomes written submissions on issues relating to the protection of human health and safety and the environment prior to making a decision on whether or not to issue the licence. The consultation RARMP and related information can be obtained via the contacts below. Submissions should reference DIR 171 and be received by 13 May 2020.

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848 CANBERRA ACT 2601

Telephone: 1800 181 030   Website: www.ogtr.gov.au

E-mail: ogtr@health.gov.au