A subsidiary of Dublin-based pharma services company Open Orphan said it is developing the world’s first human challenge model of the Omicron variant of Covid-19.

Open Orphan’s Hvivo subsidiary plans to manufacture a new Covid-19 “challenge variant” based on the Omicron strain of the virus. The subsidiary has signed an agreement with biotech company Vaxart, which will use the challenge model to test its oral vaccine candidate.

Hvivo aims to complete the manufacturing of the Covid-19 variant by the fourth quarter of this year. The subsidiary expects to conduct Omicron human challenge studies in 2023, after it receives regulatory approval and completes a characterisation study of the manufactured strain.

“Hvivo’s fight against the pandemic continues with the development of this new challenge agent,” Open Orphan CEO Yamin Khan said. “The benefits to Vaxart are immense, and we have already been contacted by a number of biopharma companies looking to test the efficacy of their products using this challenge virus.”

Human challenge trials involve the deliberate exposure of human volunteers to infectious agents, according to the WHO. Last year, Hvivo signed an £8.1m contract to test an inhaled antiviral product as part of its asthma human challenge study.

Hvivo was also involved in a human challenge study of Covid-19 which was published last March in the Nature Medicine journal. Khan believes the results of that trial gave customers the confidence to move forward with an Omicron challenge model, which he said is “less severe yet more infective”.

The characterisation study will give a dose of the Omicron challenge agent to a group of healthy male and female volunteers. Hvivo said these people will have been previously vaccinated against or infected with Covid-19, with no known risk factors for severe symptoms.

Vaxart chief medical officer Dr James Cummings said a human challenge study of the company’s oral vaccine against the Omicron variant is the “most rapid and direct way” to test its effectiveness.

“The results of this study will inform the next steps in the development of our COVID-19 vaccine candidate, which has the potential to transform personal and public health approaches to controlling the global pandemic,” Cummings said.

Open Orphan is a specialist contract research organisation that tests vaccines and antivirals through human challenge clinical trials.

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