GOSH research facilities to play key role in world's first coronavirus Human Challenge study

19 Feb 2021, 5:20 p.m.

Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH) is playing a key role in the world’s first COVID-19 human challenge study, which will get underway shortly following approval from the UK’s clinical trials ethics body.

The first-of-its-kind study for this virus will see healthy, young volunteers infected with coronavirus to test vaccines and treatments. The virus used has been manufactured at GOSH in the brand-new facilities in Zayed Centre for Research into Rare Disease in Children, in collaboration with hVIVO and Imperial. The centre is the largest single academic manufacturing unit for gene and cell therapies in the UK and one of the largest in the world.

Due to begin in the next few weeks, the study aims to establish the smallest amount of virus needed to cause infection, which will give doctors greater understanding of COVID-19 and help support the pandemic response by aiding vaccine and treatment development.

Partners in the study are the Government’s Vaccines Taskforce, Imperial, hVIVO, and the Royal Free London NHS Foundation Trust and it is backed by a £33.6 million UK government investment. Up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment at the Royal Free Hospital.

The safety of volunteers is paramount, which means this virus characterisation study will initially use the version of the virus that has been circulating in the UK since March 2020 and has been shown to be of low risk in young healthy adults. Medics and scientists will closely monitor the effect of the virus on volunteers and will be on hand to look after them 24 hours a day.

The researchers are also working very closely with the Royal Free Hospital and the North Central London (NCL) Adult Critical Care Network to ensure the study will not impact on the NHS’ ability to care for patients during the pandemic. The study will not begin without their go-ahead.

Once this initial study has taken place, vaccine candidates, which have proven to be safe in clinical trials, could be given to small numbers of volunteers who are then exposed to the COVID-19 virus, helping to identify the most effective vaccines and accelerate their development.

Mat Shaw, Chief Executive of Great Ormond Street Hospital said; “Human challenge studies have played a vital role in pushing the development of treatments for a number of diseases, including malaria, typhoid, cholera and flu. We’re really pleased that GOSH can play our part in this important study that will help with the world’s response to the pandemic. The facilities we have at the Zayed Centre for Research into Rare Disease in Children are one of the only places in the world where this sort of study is possible and it underpins our commitment to supporting transformational research at our hospital.”

The Zayed Centre for Research opened to patients in October 2019 and the centre brings together pioneering research and clinical care under one roof that will help to drive forward new treatments and cures for seriously ill children from across the UK and international patients.

It was made possible thanks to a transformative £60 million gift from Her Highness Sheikha Fatima bint Mubarak, wife of the late Sheikh Zayed bin Sultan Al Nahyan, Founder of the United Arab Emirates, in 2014. Major contributions were also made by Research England, The Wolfson Foundation, John Connolly & Odile Griffith and the Mead Family Foundation. The centre is a partnership between Great Ormond Street Hospital, UCL and Great Ormond Street Hospital Children’s Charity.

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