Coronavirus Sars-CoV-2/Covid-19 Megathread

[Tamas]

Interesting story on vaccines - UK is starting trials in January on healthy people who are deliberately infected with covid. Apparently this is called a "human challenge" trial and I think is used to narrow down and focus when there are multiple candidates, so it's been done in the past in developing typhus and other vaccines. But really fascinating from a medical ethics perspective.

Yeah a common thing that can be run for vaccine trialing.

Yeah I'd not heard of it and I remember at the start someone saying it would be unethical to deliberately infect people to test vaccines or treatments. Presumably the ethics change once you've got a relatively solid vaccine/treatment option?

The ethics change with urgency.


I guess you can do this with a very low level of risk to the patient though so I don't think its a big deal.

[The Brain]

Will it be done on volunteers or on convicts that would have been shipped to Australia?

[Josquius]

Interesting story on vaccines - UK is starting trials in January on healthy people who are deliberately infected with covid. Apparently this is called a "human challenge" trial and I think is used to narrow down and focus when there are multiple candidates, so it's been done in the past in developing typhus and other vaccines. But really fascinating from a medical ethics perspective.

I wonder how payment factors into this. Seems certainly something you'd need to be well paid for....but at the same time will that not encourage those who are desperate to volunteer to be the guinea pigs of the rich

[garbon]

Here's some information on guidance from WHO on human challenge trials.

https://www.who.int/biologicals/expert_committee/Human_challenge_Trials_IK_final.pdf

[Sheilbh]

From the FT - paid volunteers (as I think is standard for medical trials it's always volunteers but you might get paid):

UK to test vaccines on volunteers deliberately infected with Covid-19
'Human challenge trials' intended to accelerate vaccine development programmes
A clinic run by hVivo has been earmarked for the initial challenge trials © Chris Dawes/hVIVO
Clive Cookson in London yesterday

London is to host the world's first Covid-19 human challenge trials — in which healthy volunteers are deliberately infected with coronavirus to assess the effectiveness of experimental vaccines.

The UK government-funded studies are expected to begin in January at a secure quarantine facility in east London, according to several people involved in the project, which will be announced next week.

The researchers, who did not want to comment publicly ahead of the launch, said the trials would play a vital role in narrowing the large field of promising Covid-19 vaccines likely to move into clinical testing early next year.

Volunteers will be inoculated with a vaccine and a month or so later receive a "challenge" dose of Sars-Cov-2, the virus that causes Covid-19, under controlled conditions.

About 2,000 potential volunteers have signed up for challenge studies in the UK through the US-based advocacy group 1Day Sooner, which campaigns for Covid-19 infection trials and has enlisted 37,000 people worldwide. Traditional clinical trials need tens of thousands of participants and researchers would struggle to attract enough for multiple vaccine studies.

Challenge trials have a long history dating back to 1796, when the vaccine pioneer Edward Jenner inoculated eight-year-old James Phipps with live cowpox virus. More recently, they have been instrumental in developing vaccines and treatments for typhoid, cholera and malaria and in understanding how the immune system responds to flu and other viruses.

1Day Sooner is launching a UK campaign this week with a petition to parliament asking for public funding of a biocontainment facility with enough capacity to quarantine 100 to 200 participants.


The project's academic leader is Imperial College London, and it will be run by hVivo, a spinout from Queen Mary University of London that was bought earlier this year by Open Orphan, a Dublin-based pharmaceutical research organisation.

A final decision about the site of the initial challenge trials has not been made. It may be at hVivo's 24-bed quarantine clinic in Whitechapel, London, or at another larger location nearby.

Dominic Wilkinson, professor of medical ethics at Oxford university, is one of several prominent ethicists in the UK who have signed the 1Day Sooner petition.

"When we are facing an unprecedented global threat from Covid, it is an ethical imperative to carry out well-controlled challenge studies to help develop a vaccine and then to identify the best vaccines," said Prof Wilkinson. "The ones emerging first from clinical trials are unlikely to be the best."

Any Covid-19 challenge trial will need to be approved by the UK Medicines and Healthcare products Regulatory Agency and an independent research ethics committee.

"Human challenge trials can be helpful for the development of vaccines and can provide early evidence of clinical efficacy, particularly when there are low rates of infection of the virus in the population," said the MHRA.

"The safety of trial participants is our top priority and any proposal from a developer to include a human infection challenge as part of a clinical trial for development of a vaccine would be considered on a benefit-risk basis, with risks monitored for and minimised in the proposed trial design."

The petition organiser of 1Day Sooner in the UK is 18-year-old Alastair Fraser-Urquhart who is devoting his time to the campaign before going to University College London to study cancer biology next year.

"By exposing just a few hundred carefully selected young, healthy people to coronavirus — a virus which for this group is far less deadly than routine procedures such as a live kidney donation — we can test a huge range of vaccines very quickly," said Mr Fraser-Urquhart.

One crucial aspect of challenge trials is to select and purify an appropriate strain of the virus that is genetically representative of Sars-Cov-2 currently circulating in the population, and choose doses that will infect volunteers without overloading their immune system.

It is also essential to have a "rescue remedy" on hand to prevent serious illness in participants. The London trial will initially use remdesivir, the only antiviral drug so far proven to work against Covid-19.

Volunteers who take part in hVivo's influenza challenge studies receive up to £3,750 compensation. The payment for Covid-19 trials is likely to be somewhat higher because the isolation will last longer — potentially as long as a month.

The hVivo facility could be divided into three zones of eight beds each, to test three different vaccines at the same time. There is likely to be intense demand for its services and larger facilities may be opened later.

In the US, the National Institutes of Health has awarded Colorado State University a contract worth at least $3.6m to support the manufacturing of two viral strains that could be used for human challenge studies. It is preparing the manufacturing process for one of the strains. NIH is also investigating the technical and ethical requirements for challenge trials.

But Nadine Rouphael, a leading vaccine researcher at Emory University in Atlanta and one of several scientists who are keen to carry out challenge studies in the US, said: "There is no urgency at NIH. The UK is well ahead — and that's great."

This story has been amended to make clear that the initial site for the challenge trials has not been decided.

[Syt]

Usually only Phase 1 participants are paid. At least during my time it was unethical to pay Phase 2 or 3 participants.

[alfred russel]

Another trauma you fuckers and your excessive lockdowns are imposing on me....

The leading republican senate candidate in georgia launched an ad announcing she is "more conservative than attila the hun". Her republican senate opponent is countering with a fact sheet on attila the hun including that he was nonchristian, killed christians, was in favor of post natal abortion, and nicknamed the "scourge of god" by the romans.

Late Roman history would now be watercooler talk at the office. This is my moment to shine, I've been waiting for this my whole life, and I can't go to work. 

[crazy canuck]

 

[Valmy]

Another trauma you fuckers and your excessive lockdowns are imposing on me....

The leading republican senate candidate in georgia launched an ad announcing she is "more conservative than attila the hun". Her republican senate opponent is countering with a fact sheet on attila the hun including that he was nonchristian, killed christians, was in favor of post natal abortion, and nicknamed the "scourge of god" by the romans.

Late Roman history would now be watercooler talk at the office. This is my moment to shine, I've been waiting for this my whole life, and I can't go to work. 

Sorry man.

Is this a state senate seat or the US senate? And why are two Republicans running against each other in either case? Will there be a runoff if nobody gets 50%?

[alfred russel]

Is this a state senate seat or the US senate? And why are two Republicans running against each other in either case? Will there be a runoff if nobody gets 50%?

It is an open US Senate seat. The election is without a primary, so there are democrats and republicans in the race: the top 2 move to a runoff. There are two major republicans and two major democrats, so probably it will end up with the top republican against the top democrat--I think that is why the republicans are attacking each other. But the polling shows the two republicans may finish 1 and 2 so there are calls for the second place democrat to drop out.

[celedhring]

Isn't the saying usually about being to the right of Genghis Khan?

[Eddie Teach]

Not around here. My dad used to make that Attila joke.

[Syt]

Isn't the saying usually about being to the right of Genghis Khan?

Not in the lyrics to Evita.

[crazy canuck]

Isn't the saying usually about being to the right of Genghis Khan?

Yeah, but that was a common saying 20 years ago.  At least around here.

[Barrister]

Isn't the saying usually about being to the right of Genghis Khan?

No, I've definitely heard Atilla, not Genghis.