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Australia is set to host the first human clinical trial of a genetically modified adenovirus vaccine for Covid-19 delivered via nasal spray.
Avance Clinical, an Australian contract research organisation, has applied to the office of the gene technology regulator for permission to conduct the phase 1 clinical trial on behalf US company Tetherex Pharmaceuticals Corporation.
The trial from June to September proposes using genetic modification to prevent the virus multiplying and insert a gene encoding the Sars-Cov-2 spike protein to help people produce antibodies against Covid-19.
A health department spokesman said the trial related to a vaccine that was “new to Australia” and was sponsored by Tetherex. It is seeking men and women aged 18 to 55 with no history of blood clot disorders.
Adenoviruses modified for nasal spray are a promising field for the second generation of Covid vaccines, potentially allowing prevention through sprays with less stringent refrigeration requirements or could even be administered at home.
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Nasal spray vaccine candidates are also being developed by US company Altimmune, a partnership between Bharat Biotech in India and Washington University, and AstraZeneca.
Guardian Australia understands that Australian science agency CSIRO has conducted preclinical studies, yet to be published, which found nasal sprays compare favourably with injections when it comes to effectively building immunity to Covid.
The Avance Clinical trial proposes importing a genetically modified human adenovirus from the US to clinical trial sites, including Nucleus Network (Brisbane), CMAX (Adelaide), Linear (Perth) and Scientia (Sydney).
The application seeks approval for up to 1,000 healthy participants to be administered the vaccine at the trial sites and hospitals in Australia, although information provided to the US government suggests its enrolment will be 40 people. The application rates the risk from the trial as “negligible”.
“Preclinical studies have been undertaken in animal models which showed good efficacy and no major adverse reactions,” it said.
In July Avance announced US pharmaceutical company Atossa Therapeutics had engaged it for clinical studies of its drug candidate AT-301, a preventive treatment to be administered daily by nasal spray. Phase 1 final results of that trial concluded in March.
Avance markets itself to US pharmaceutical companies to conduct clinical trials in Australia. Chief executive Yvonne Lungershausen said Australian clinical trials were “recognised globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the [Food and Drug Administration]”.
“Increasingly our clients are also tapping the generous 43.5% Australian government rebate to support their clinical research,” she said.
In March Altimmune announced its single dose intranasal vaccine adCOVID had shown in preclinical trials it prevents Covid-19 and blocks viral replication.
Studies in mice found it “provided 100% protection against a lethal challenge” from Covid-19, Altimmune said.
Altimmune recently started a phase 1 clinical trial of AdCOVID and anticipates having a data readout from this trial in the second quarter of 2021.
The AstraZeneca adenovirus vaccine was to form the backbone of Australia’s vaccine program, with more than 50m doses made locally by CSL.
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But a warning applied to its use by under-50s over a risk of a rare blood clot has caused a restructure of the program.
Australia has bought 20m extra doses of Pfizer, reserved Pfizer doses for under-50s and opted against purchasing the Johnson & Johnson vaccine, because it an adenovirus vaccine, like AstraZeneca.
On Thursday Labor leader Anthony Albanese announced that if elected Labor would use its national reconstruction fund to deliver mRNA vaccines and RNA medicine manufacturing capacity in Australia.
The announcement follows the Victorian government committing $50m to develop the manufacturing capacity and prime minister Scott Morrison indicating the federal government was likely to follow suit.
“The Morrison government has had over a year to invest in this capability and they haven’t, once again leaving Australia missing out on new jobs and manufacturing opportunities,” Albanese said.
The inability to produce mRNA vaccine “not only undermines our ability to tackle the Covid-19 crisis over the longer term, but it means we miss out on a new global industry estimated to be worth $5.5bn in just three years’ time”.