Open Orphan gets final go-ahead for Covid-19 human trial

Open Orphan, the Irish clinical trials group, has secured ethical approval for a trial that involves deliberately infecting people with Covid in a controlled setting to see how much exposure is needed to start displaying symptoms.

The company's hVivo subsidiary will then treat the trial volunteers with a vaccine in what is called a human challenge study.

The Irish company is now calling for volunteers for the human challenge study that will take place in London. It needs 90 people between the ages of 18 and 30.

The study, funded by the British government, is due to commence shortly and is scheduled to be completed in May. The ethics committee approval was the last sanction required before the study can commence.

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Open Orphan and the Imperial College London, which is sponsoring the study, hope it will play a pivotal role in developing effective vaccines and treatments for Covid-19

"Covid-19 human challenge studies have the potential to play an important role in providing data and information that will help continue to develop vaccines to control the pandemic," said Dr Andrew Catchpole, chief scientific officer at hVivo.

“This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required,” he said. “Data from this study will immediately facilitate the challenge model to be used for vaccine efficacy testing as well as to answer a wide range of fundamental scientific questions that are not feasible with traditional field trials, such as exactly what type of immunological response is required to confer protection from re-infection.”

Dr Chris Chiu, the chief investigator of the study said the recent worsening of the pandemic and urgent need to vaccinate people quickly and effectively "have raised new questions about Covid-19 and how to best protect ourselves against it".

“This study will immediately tell us about mild and asymptomatic infection, which is a major driver of continuing transmission” he said. “While the first wave of vaccines are being rolled out, human challenge studies could also be pivotal in helping to shape the timings and doses of existing vaccines, finding out how long one dose is protective for, and if they are effective against new variants of the virus.”