United Kingdom to begin trials infecting healthy volunteers with COVID in early 2021
24 Octobre, 2020, 16:13 | Auteur: Yves Courtet
That phase is scheduled to be wrap up sometime next year. Thousands of subjects are recruited, randomized into either placebo or vaccine groups, and then followed for months. The aim of the United Kingdom challenge studies will be twofold: firstly to ascertain the level of virus that causes an infection; and secondly to assess the efficacy of vaccine candidates.
Challenge studies have been used to study vaccines and medicines against influenza and a range of other viral pathogens.
Human challenge studies are typically used to test vaccines against mild infections to avoid exposing volunteers to a serious illness if the vaccine does not work. As the prevalence of COVID-19 rises and falls in populations, it can make it hard for traditional vaccine trials to assess if vaccines work, because volunteers receiving the vaccine may not be naturally exposed to the virus. The approach, called a human challenge trial (HCT), is not unheard of, as similar trials take place in the US each year involving the influenza virus.
The studies would be conducted by Imperial College London in partnership with the Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVivo, a company that has experience conducting testing. The company is going to get around $13 million for conducting the characterization study depending on the number of volunteers involved.
The first stage of the project will explore the feasibility of exposing healthy volunteers to the SARS-CoV-2 coronavirus. The goal of this initial phase is to find the lowest dose of virus that can consistently lead to COVID-19 in most subjects.
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The study will take place at a specialist Royal Free Hospital unit in London.
This virus characterization phase is expected to run until May 2021.
That speed is one reason why the 1DaySooner.org volunteers have supported human challenge trials. The participants will remain under quarantine at a designated facility in London until they test negative for the virus, the researchers said. Belgium invested €20 million in a facility to run challenge studies early in the pandemic and Colorado State University has a US government contract to develop SARS-CoV-2 strains that could be used in human challenge studies. Katharine Wright, from the Nuffield Council on Bioethics, cites informed consent as perhaps one of the most important aspects of these kinds of trials. "These could nearly take the place of phase 3 trials or at least go alongside them", says Richards.
Marcos and other young volunteers say they want to take part to help bring an end to the pandemic after seeing the havoc it has wreaked.
A total of 184 countries and economies have now joined COVAX, an global initiative aimed at ensuring equitable access to COVID-19 vaccines across the world, according to World Health Organization Director-General Tedros Adhanom Ghebreyesus. However, he does add these kinds of trials can sometimes be of limited value as they only evaluate vaccine response in the youngest, healthiest populations. That's one of the main reasons that Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and member of the White House Coronavirus Task Force, said earlier this year that the studies are not ethically justified-at the time, mid-July, daily case numbers were peaking.
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