# Open Orphan Ethics Approval Granted for COVID-19 Human Challenge Study Model

- Link: https://www.directorstalkinterviews.com/open-orphan-ethics-approval-granted-for-covid-19-human-challenge-study-model/412961683
- Published: 2021-02-17T09:47:39+00:00
- Author: Giles

**Open Orphan plc** ([LON:ORPH](https://www.directorstalkinterviews.com/company/open-orphan-plc/orph.l)),
a rapidly growing specialist pharmaceutical services clinical research organisation(
CRO) and world leader in vaccine and antiviral testing using human challenge clinical
trials, has announced the world’s first 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.

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.   

Individuals interested in taking part in this research can visit [www.UKCovidChallenge.com](http://www.ukcovidchallenge.com/)
to learn more.

> **Chief Scientific Officer, 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.  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. 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.”

Open Orphan CEO Cathal Friel will be presenting at a Mello event on Monday, 22 February.
To register for this, please follow the link: [https://melloevents.com/mellomonday-22nd-february-2021/](https://urldefense.proofpoint.com/v2/url?u=https-3A__melloevents.com_mellomonday-2D22nd-2Dfebruary-2D2021_&d=DwMFAg&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=LArnpBofWu6Mctd-Pyznmb9dp49FvkABteO9dHUHaKA&m=NOh7rIBjstY6DcsaQtVP_mFZwNhbu4jvyY-XIOVUU20&s=8qRLlUJXFm6BhOh9aPQy37GGTY-1STrMl_cRr9epuPI&e=)

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