United Kingdom study that will infect volunteers with coronavirus approved

  • United Kingdom study that will infect volunteers with coronavirus approved

United Kingdom study that will infect volunteers with coronavirus approved

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.

The human challenge study is being delivered by a partnership between the Government's Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the industry-leading clinical company hVIVO, which has pioneered viral human challenge models.

Starting in the next few weeks, the human challenge trial will involve up to 90 carefully selected, healthy adult volunteers being deliberately exposed to Covid-19 in a safe and controlled environment.

The study will try to determine the smallest amount of virus needed to cause infection.

The doctors will use the original virus as there is much less information available about the new virus variants.

The study is backed by £33.6million Government investment and could speed up development of vaccines and care.

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".

Volunteers will receive around £4,500 (€5,181) to participate in the study which will involve some 17 days of quarantine and follow-ups over 12 months.

Teenagers to be exposed to coronavirus in world-first UK study

The Chair of the Vaccines Taskforce Clive Dix said: "No one vaccine is likely to be suited to everyone so we must continue to develop new vaccines and treatments for Covid-19 coronavirus".

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.

This is not the same as standard vaccine clinical trials, where the vaccine is given to participants who have acquired the infection naturally. "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".

Researchers say that younger adults have immune systems which are different from older adults and people who are more at risk of severe Covid-19, and so, it is not always possible to directly extrapolate findings from this study situation to patients in the community.

"The absolute priority, of course, is the safety of volunteers", said Peter Openshaw, a professor of experimental medicine at Imperial College London, which is co-leading the project with the United Kingdom government's vaccines task force and the clinical company hVIVO.

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

"hVIVO has been successfully undertaking challenge studies since 2001 and we have run challenges successfully for a range of infectious diseases and respiratory diseases, that includes Respiratory Syncytial virus, asthma...influenza, COPD, and many others", said Catchpole.

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.