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Doherty Clinical Trials Ltd (DCT)

Influenza A and B virus

GM Influenza A and B viruses are produced using gene technology and are genetically similar to seasonal influenza viruses, thus sharing similar traits with them

This licence allows Doherty Clinical Trials Ltd. to conduct clinical trials involving recombinant influenza viruses produced through gene technology. These studies aim to investigate viral infections and the development of immunity. These trials also seek to evaluate methods for preventing and controlling influenza, including the effectiveness of new drugs or vaccines.

Influenza is an acute respiratory viral infection caused by influenza A or B viruses, with up to 650,000 deaths worldwide annually. For most healthy adults, seasonal influenza is a self-limited illness from which complete recovery is expected. These trials aim to better understand how the human immune system fights off influenza infections. Understanding the physiological and immunological responses of humans to these viruses is critical to develop vaccines and antivirals drugs for the control of influenza.

GMOs are produced from seasonal influenza viruses using a method called reverse genetics. The GMOs produced are similar to seasonal influenza viruses and are not more pathogenic than influenza viruses already present in the environment. The recombinant influenza viruses will be grown in a facility in the USA and imported to Australia. This is the first time that clinical trials with GM influenza will be used in healthy participants in Australia; however, these types of trials have been conducted in several countries including the USA. The first GMO to be used in the clinical trial proposed under this licence has been used in a trial authorised by the FDA in the USA. No serious adverse events were reported.

The DCT is authorized to conduct clinical trials with recombinant influenza viruses at DCT clinical trial sites over a 5-year period, with a maximum of 150 trial participants. The trial participants will be accommodated in an isolation room during the trial period. Only authorised staff will be allowed in the trial room while wearing appropriate personal protective equipment (PPE) during this time.

The consultation Risk Assessment and Risk Management Plan (RARMP) prepared for this application concluded that the clinical trial poses negligible to moderate risks to people or the environment are based on the pathogenicity of circulating influenza. A number of licence conditions have imposed to restrict the spread and persistence of the GMO. For example;

• All clinical activities must be conducted at the DCT clinical trial facility inside isolation room.
• Exclusion of trial participants who have close contact with vulnerable individuals such as pregnant or immunocompromised individuals.
• The staff members must be vaccinated against influenza viruses

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