Human Challenge Trials Will Deliberately Infect Dozens in the UK

Young, healthy people will be intentionally exposed to the virus responsible for COVID-19 in a first-of-its kind ‘human challenge trial’, the UK government and a company that runs such studies announced on 20 October. The experiment, set to begin in January in a London hospital if it receives final regulatory and ethical approval, aims to accelerate the development of vaccines that could end the pandemic.

Human challenge trials have a history of providing insight into diseases such as malaria and influenza. The UK trial will try to identify a suitable dose of the virus SARS-CoV-2 that could be used in future vaccine trials. But the prospect of deliberately infecting people—even those at low risk of severe disease—with SARS-CoV-2, a deadly pathogen that has few proven treatments, is uncharted medical and bioethical territory.

Proponents of COVID-19 challenge trials have argued that they can be run safely and ethically, and that their potential to quickly identify effective vaccines outweighs the low risks to participants. But others have raised questions about the safety and value of these studies, pointing out that large-scale efficacy trials involving tens of thousands of people are expected to deliver results on several COVID-19 vaccines soon.

“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly. However, such studies are enormously informative about a disease,” said Peter Openshaw, an immunologist at Imperial College London and investigator on the study, in a press statement. “It is really vital that we move as fast as possible towards getting effective vaccines and other treatments for COVID-19, and challenge studies have the potential to accelerate and de-risk the development of novel drugs and vaccines.”

Dose testing

The planned COVID-19 challenge study will be led by a Dublin-based commercial clinical-research organization called Open Orphan and its subsidiary hVIVO, which runs challenge trials on respiratory pathogens. It will take place in the high-level isolation unit of the Royal Free Hospital in north London, says Open Orphan executive chair Cathal Friel.

The UK government’s COVID-19 Vaccine Taskforce has agreed to pay the company up to £10 million (US$13 million) to conduct the trial, with the possibility of contracting Open Orphan to run several more to test various vaccines. The UK Medicines and Healthcare Regulatory Agency (MHRA), which regulates clinical trials in the United Kingdom, and an ethical review committee, still need to approve the initial trial and its design, and that of future studies.

The initial trial will involve an estimated 30–50 participants, says Andrew Catchpole, a virologist and the chief scientific officer at Open Orphan who is leading the work. It is open only to healthy adults aged 18–30.

The precise design of the study has not been finalized. But it is likely that a small number of participants will receive a very low dose of a SARS-CoV-2 ‘challenge strain’ derived from a currently circulating virus and grown under stringent conditions. If none or few of the participants become infected, the researchers will seek permission from an independent safety monitoring board to expose

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UK plans COVID-19 ‘challenge’ trials that deliberately infect volunteers

LONDON (Reuters) – Britain will help to fund trials using a manufactured COVID-19 virus to deliberately infect young healthy volunteers with the hope of accelerating the development of vaccines against it.

The government said on Tuesday it will invest 33.6 million pounds ($43.5 million) in the so-called “human challenge” trials in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.

If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.

Using controlled doses of virus, the aim of the research team  will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are  at the lowest risk of harm, the scientists leading the studies said in a briefing.

Up to 90 volunteers could be involved at the initial stages, they said, and virus to be used will be manufactured in labs at London’s Great Ormond Street Hospital.

Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.

Critics of human challenge trials say deliberately infecting someone with a potentially deadly disease for which there is currently no effective treatment is unethical.

Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.

Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.

He said that while studies have show remdesivir has little or no effect on severe COVID-19 cases, his team has a “strong belief” that it will be an effective treatment if given in the very earliest stages of infection.

A spokeswoman for the World Health Organization said that there are “very important ethical considerations” when approaching such human challenge trials.

“What is critical is that if people are considering this, it must be overseen by an ethics committee and the volunteers must have full consent. And they must select the volunteers in order to minimise their risk,” she told reporters in Geneva.

Chiu said his team’s “number one priority is the safety of the volunteers”.

“No study is completely risk free, but (we) will be working hard to ensure we make the risks as low as we possibly can,” he said.

Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said last week it was carrying out preliminary work for the trials.

Reporting by Kate Kelland and Paul Sandle in London, with additional reporting by Stephanie Nebehay in Geneva, Editing by Michael Holden and Angus MacSwan

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UK Plans COVID-19 ‘Challenge’ Trials That Deliberately Infect Volunteers | Top News

LONDON (Reuters) – Britain will help to fund trials using a manufactured COVID-19 virus to deliberately infect young healthy volunteers with the hope of accelerating the development of vaccines against it.

The government said on Tuesday it will invest 33.6 million pounds ($43.5 million) in the so-called “human challenge” trials in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust.

If approved by regulators and an ethics committee, the studies will start in January with results expected by May 2021, the government said.

Using controlled doses of virus, the aim of the research team  will initially be to discover the smallest amount of virus it takes to cause COVID-19 infection in small groups of healthy young people, aged between 18 and 30, who are  at the lowest risk of harm, the scientists leading the studies said in a briefing.

Up to 90 volunteers could be involved at the initial stages, they said, and virus to be used will be manufactured in labs at London’s Great Ormond Street Hospital.

Chris Chiu, an Imperial College scientist on the team, said the experiments would rapidly increase understanding of COVID-19 and the SARS-CoV2 virus that causes it, as well as accelerating development of potential new treatments and vaccines.

Critics of human challenge trials say deliberately infecting someone with a potentially deadly disease for which there is currently no effective treatment is unethical.

Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.

Chiu said the plan for initial studies – which are aimed at assessing how much virus it takes to infect someone with COVID-19 – is to immediately treat volunteers with the Gilead antiviral drug remdesivir as soon as they are infected.

He said that while studies have show remdesivir has little or no effect on severe COVID-19 cases, his team has a “strong belief” that it will be an effective treatment if given in the very earliest stages of infection.

A spokeswoman for the World Health Organization said that there are “very important ethical considerations” when approaching such human challenge trials.

“What is critical is that if people are considering this, it must be overseen by an ethics committee and the volunteers must have full consent. And they must select the volunteers in order to minimise their risk,” she told reporters in Geneva.

Chiu said his team’s “number one priority is the safety of the volunteers”.

“No study is completely risk free, but (we) will be working hard to ensure we make the risks as low as we possibly can,” he said.

Britain’s hVIVO, a unit of pharmaceutical services company Open Orphan, said last week it was carrying out preliminary work for the trials.

(Reporting by Kate Kelland and Paul Sandle in London, with additional reporting by Stephanie Nebehay in Geneva, Editing by Michael Holden and Angus MacSwan)

Copyright 2020 Thomson Reuters.

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