United Kingdom approves trial deliberately exposing volunteers to virus

19 Février, 2021, 19:58 | Auteur: Auguste Feret
  • TOPSHOT-BRITAIN-HEALTH-VIRUS

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.

The study is due to begin in the next few weeks and will be delivered by experts from the Government's Vaccines Taskforce, Imperial College London, the Royal Free London NHS Foundation Trust and the company hVIVO, which has pioneered viral human challenge models.

The study will recruit up to 90 healthy volunteers between the ages of 18 and 30 with no previous history or symptoms of Covid-19, no underlying health conditions and no known adverse risk factors for Covid-19 such as diabetes or being overweight.

The aim of the human challenge trial is to establish the smallest amount of virus needed to cause infection. 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.

The volunteers, who are being encouraged to come forward for the study, will be between 18 and 30 and will be exposed to the variant circulating in the United Kingdom since March 2020. 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.

Volunteer hopefuls will register for the trials.

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.

Catchpole said: "The main benefits are that this allows us to test new vaccines that are required to deal with the new variations of Covid-19, ie. the second generation of vaccines which will be required later this year or early next".

There are certain limitations of HCTs, since they can not be conducted for diseases that have a high case fatality rate or for diseases for which no course of treatment is available.

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The aim of the study is to allow doctors to gain a better understanding of Covid-19 and help support the pandemic response by aiding vaccine and treatment development.

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.

Only vaccines that "have proven to be safe in clinical trials" will be used.

In the past, human challenge studies have played important roles in accelerating the development of treatments for diseases including malaria, typhoid, cholera, norovirus and flu.

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

"We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection", he said.

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.

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

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