Call for volunteers for world’s first coronavirus human challenge study

Cornelia Mascio
Febbraio 19, 2021

It will involve up to 90 carefully selected, healthy adult volunteers being exposed to the virus in a safe and controlled environment.

Business Secretary Kwasi Kwarteng said: "Researchers and scientists around the world have made great progress in understanding Covid-19 and developing critical vaccines to protect people, but we are only partway up the mountain we need to climb". This is the initial strain of the virus, which emerged in March 2020, as it is believed to present low risk to young, healthy adults. Medics and scientists then closely monitor the effect on volunteers 24 hours per day to see exactly how the vaccine works and to identify any side effects.

Interim chairman of the Vaccines Taskforce, Clive Dix, suggested that the study would help develop new vaccines and treatments for Covid-19.

British regulators have approved the world's first coronavirus human challenge trial, in which volunteers will be deliberately exposed to the virus to study how the infection spreads. "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".

"We are asking for volunteers aged between 18 and 30 to join this research endeavor to help us to understand how the virus infects people and how it passes so successfully between us", says Chiu.

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.

Third, "very early administration of antivirals will be given at the onset of infection as a pre-emptive intervention therapy as a precautionary measure for the first groups of volunteers" and finally "we will ensure very close medical monitoring throughout the trial and for year-long follow up visits".

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

Once the most appropriate dosage of the virus has been found, vaccines and treatments will be tested against it.

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

This includes how a person who is infected with Covid-19 virus transmits infectious virus particles into the environment.

The study is being conducted through a partnership between Imperial College London, the government's Vaccines Taskforce, the Royal Free London NHS Foundation Trust and the clinical company hVIVO.

The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) are the UK's regulators responsible for providing ethics and regulatory approval, respectively for all human clinical trials.

Its secure clinical research facilities are specifically created to contain the virus, the government said.

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

A specially-appointed independent REC has approved the study, and after reviewing the protocol, the MHRA concluded the virus characterisation study did not require its approval because the study does not involve an investigational medicinal product.

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