World’s first coronavirus human challenge study gets green light in UK

Marco Green
February 19, 2021

An ethics board that oversees clinical trials in the United Kingdom today said a research team there can begin to intentionally infect volunteers with the virus that causes COVID-19, a world-first experiment meant to accelerate research into vaccines against the disease.

With the ethics approval secured, the Covid-19 human challenge study - the protocol for which was developed by Open Orphan's hVIVO for the UK Government - could begin within a month in Covid-19 secure facilities at the Royal London NHS Foundation Trust.

The trial, which will start in the coming weeks, will involve up to 90 carefully selected adult volunteers who will deliberately be exposed to the virus in a safe and controlled environment.

It aims to establish the least amount of virus needed to cause infection, and how the immune system reacts to the coronavirus. It is hard to study the efficacy of vaccines as those in traditional trials may not be naturally exposed to the virus, whereas human challenge studies deliberately infect volunteers with Covid-19.

As we learned more about this novel coronavirus over the course of 2020 calls for human challenge trials increased and in October a year ago the United Kingdom government announced a large investment into running these trials.

Scientists have used human challenge trials for decades to learn more about diseases such as malaria, flu, typhoid, and cholera, and to develop treatments and vaccines against them. The study was approved by the UK's clinical trials ethics body and expected to begin in a few weeks.

The study is not created to induce symptoms in volunteers and as soon as people start to shed virus from their nose, they will be given remdesivir as a pre-emptive treatment.

It will give doctors a greater understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.

The controversial trials, which will allow scientists to monitor the virus' behavior and how it responds to vaccines, were first announced last October. "Second, for vaccines which are in the late stages of development and already proven to be safe and effective through Phase III studies, human challenge studies could help us further understand if the vaccines prevent transmission as well as preventing illness".

"1Day Sooner congratulates Imperial College London and the UK Vaccine Taskforce on receiving ethical and regulatory approval for their planned COVID-19 human challenge trial", the organization said in a statement.

hVIVO chief scientific officer Dr Andrew Catchpole said Covid-19 "human challenge" studies have the potential to play a vital role in providing data and information that could firmly get the pandemic under control.

The trials will be conducted in "secure clinical research facilities" that are "specifically created to contain the virus", according to the government, which stressed that the safety of trial participants was paramount.

In this way, the participants are "challenged" by the virus.

The initial study has been reviewed by the Health Research Authority to ensure that it meets the highest ethical standards.

The virus researchers will use in the trials was produced at Great Ormond Street Hospital.

Other reports by Click Lancashire

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