Australia advances first human trial of nasal spray vaccine

As the vaccination campaign progresses in different countries with the aim of alleviating the COVID-19 pandemic, Australian scientists prepare to launch first human clinical trial of genetically engineered adenovirus vaccine to prevent coronavirus administered by nasal spray.

Avance Clinical, an Australian contract research organization, has applied to the Office of the Regulator of Genetic Technology for permission to conduct the Phase 1 clinical trial on behalf of the US-based Tetherex Pharmaceuticals Corporation.

The rehearsal, scheduled from June to September, proposes to use genetic modification to prevent the virus from multiplying and to insert a gene encoding the SARS-CoV-2 spike protein to help people make antibodies against the disease.

A spokesperson for the Australian Department of Health said the trial was linked to a ‘new to Australia’ vaccine sponsored by Tetherex, in which men and women between the ages of 18 and 55 without a history of bleeding disorders were invited to participate.

Adenoviruses modified to be delivered by nasal spray are a promising area for what researchers are calling the second generation of COVID vaccines., potentially allowing prevention through aerosols with less stringent refrigeration requirements or could even be administered at home, as published The Guardian.

Other nasal spray vaccine candidates are also being developed by the American company Altimmune, a partnership between Bharat Biotech in India and the University of Washington, and AstraZeneca.

As UK media report, Australian science agency CSIRO has conducted pre-clinical studies, which have yet to be published, which have found that nasal sprays compare favorably to injections when it comes to effectively developing l immunity against COVID-19.

The application seeks approval for the vaccine to be administered to up to 1,000 healthy volunteer participants at Australian hospitals and testing sites., although information provided to the US government suggests that their registration will be 40 people. The application rates the risk of the test as “negligible”.

“Preclinical studies have been performed in animal models which have shown good efficacy and no major side effects,” the researchers said.

In July, Avance announced that the US pharmaceutical company Atossa Therapeutics had hired it to conduct clinical studies on its drug candidate AT-301, a preventive treatment administered daily by nasal spray. The final results of phase 1 of this trial were completed in March.

The CEO of the pharmaceutical company, Yvonne Lungershausen, said that Australian clinical trials have been “recognized around the world for their speed and accuracy and the fact that clinical data is accepted by all major regulatory authorities, including the US Food and Drug Administration.”

In March, Altimmune announced that its single-dose intranasal vaccine adCOVID had been shown in preclinical trials to prevent COVID-19 and block viral replication.

Studies in mice have found that it “provides 100% protection against a deadly challenge” of coronavirus disease, the company said.

Altimmune recently launched a Phase 1 clinical trial of AdCOVID and plans to read data from that trial in the second quarter of 2021.

The COVID-19 vaccine developed by AstraZeneca was to form the backbone of Australia’s vaccination program. But a warning applied to its use in those under the age of 50 because of the risk of blood clots and thrombosis caused a restructuring of the program.

Australia bought an additional 20 million doses of Pfizer, which it reserved for those under the age of 50 and chose not to purchase the Johnson & Johnson vaccine, as it is developed from adenovirus and has also been observed in vaccinated people. the same side effect.

Last Thursday Labor leader Anthony Albanese announced that, if elected, Labor would use its National Reconstruction Fund to provide mRNA vaccines and RNA drug manufacturing capacity in Australia.

The announcement follows the Victorian government’s commitment of $ 50 million to develop manufacturing capacity and Premier Scott Morrison has indicated that the federal government will likely follow suit.

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