: Dozens of volunteers to be deliberately infected with COVID-19 in effort to speed up vaccine development

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The ‘human challenge trials’ would need to be approved by the U.K. health care regulator.

Vincenzo Pinto/Agence France-Presse/Getty Images

Young and healthy volunteers in London are to be deliberately infected with the SARS-CoV-2 coronavirus early next year, in a bid to accelerate the development of a vaccine.

Experts from Imperial College London, the National Health Service and Irish company Open Orphan’s ORPH, -7.92% hVivo unit will explore and establish the world’s first “human challenge trial” for COVID-19, the U.K. government said on Tuesday, as it pledged £33.6 million for the study.

The initial trial will involve up to 90 healthy adults aged between 18 and 30 with no underlying health conditions, who are at the lowest risk of harm. 

If approved by regulators and health and ethics committees, the study would start in January, with results expected by May 2021.

Human challenge studies, which have been successfully used in the past to develop vaccines for malaria and cholera, involve deliberately infecting volunteers to test the effectiveness of vaccines.

Critics of such trials say intentionally infecting people with COVID-19 poses an ethical dilemma, because there are few treatment options for the disease.

Opinion: Here’s the ethics case for deliberately infecting volunteers with COVID-19 to speed up a vaccine

However, the government said that the study can help speed up the process of demonstrating how effective the vaccines are.

“Human challenge studies can increase our understanding of COVID-19 in unique ways and accelerate development of the many potential new COVID-19 treatments and vaccines,”  said Dr. Chris Chiu, the study’s lead researcher from Imperial College London.

“My team has been safely running human challenge studies with other respiratory viruses for over 10 years. No study is completely risk free, but the Human Challenge Programme partners will be working hard to ensure we make the risks as low as we possibly can,” he added.

In the first stage of the trials, researchers will aim to discover the smallest amount of virus needed for a person to develop COVID-19 and elicit an immune response by slowly increasing the viral dose, a process known as a “virus characterization study.”  

The aim is to infect volunteers with the lowest possible dose to trigger viral replication but minimize symptoms. The volunteers will be monitored for up to a year after taking part in the study to ensure their long-term well-being, and they will be financially reimbursed for their time. 

Researchers will have Gilead Sciences’ GILD, -0.62%  antiviral drug remdesivir ready to administer during the trial to limit the risk of severe disease, Imperial College London’s Chiu said in a media briefing on Tuesday.

Read: Remdesivir didn’t reduce mortality among COVID-19 patients in WHO study

The results will then be used to study how potential vaccines work in the body to stop or prevent COVID-19, and to look at possible treatments.

It comes as hundreds of COVID vaccines are being developed around the world, and with several already in the final stages of testing.

Read: There are four coronavirus vaccines in late-stage studies — here’s how they differ

The proposed research still needs to be approved by an ethics committee and will need approval from regulators including the Medicines and Healthcare products Regulatory Agency before volunteers can participate.

The World Health Organization (WHO) issued ethical guidance in May on the use of COVID-19 human challenge studies. The WHO said the method can be “substantially faster” and requires far fewer participants to be exposed to experimental vaccines, while also being useful in comparing multiple vaccine candidates. However, it said any human challenge studies would have to meet eight strong criteria to be considered ethically acceptable.

The WHO said that included selecting low-risk volunteers — healthy adults aged 18-30 — reducing the number of participants, close monitoring, and providing “high-quality supportive care.” It added that there could still be risks of infection, serious illness, and death.