Open Orphan, a specialist pharmaceutical services clinical research organisation (CRO) has been approved to develop the world’s first Covid-19 human challenge model, which will take place in the UK.
The Covid-19 characterisation study has received approval from a specially convened Research Ethics Committee (REC). This news follows the announcement on 20 October 2020 of Open Orphan subsidiary hVIVO's contract with the UK Government to develop a COVID-19 human challenge study model.
In a recent interview with Scientific Computing World, director of the laboratory operations, Adam French, noted that hVIVO had adopted the use of a LIMS from Labware to help scale up the sample throughput for this human challenge study. ‘We have got the facilities setup and we are planning on characterising the virus. We have manufactured a challenge virus and we plan to have the first subjects next month. Part of all of that is a massive increase in the number of samples and overall sample throughput which is why we have since purchased, set up and are in the process of expanding the use of - Labware LIMS.'
‘LIMS systems are amazing tools and allow us to track samples and have instant access to the data. Backend reporting tools are critical for us and being able to feed into stats and having that data much sooner. One of the key outputs is the viral load or the level of infection that each subject has had. We take multiple samples each day for each subject so all of that data needs to be put together,’ added French.
The initial virus characterisation study will inoculate up to 90 volunteers, between the ages of 18 and 30 years old, to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment.
The study is set to commence shortly and is funded by the UK Government. Imperial College London is the clinical study sponsor and the study will be conducted by hVIVO at the Royal Free London NHS Foundation Trust's specialist clinical research unit, under the scrutiny of highly trained scientists and medics. The virus being used in the characterisation study has been produced under hVIVO's supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.
The REC approval completes all the independent external body approvals required before the study can commence.
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said: ‘Ethical review of the research plan is a crucial part of conducting clinical studies and approval from the Ethics Committee represents a very important milestone in the development of the COVID-19 challenge model. 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.’
‘This study is a key enabling study to establish the COVID-19 challenge model and determine the lowest possible dose of virus required,' Catchpole continued. '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, Clinical Reader, honorary consultant and chief investigator of this 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. 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.’
‘The Research Ethics Committee has provided detailed independent scrutiny,' added Chiu. 'Their favourable opinion is a crucial step towards getting this study open and running, and greatly helps us in our efforts to minimise risks and enhance the quality of the research.’
