UK starts COVID human challenge studies

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hedrick

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They expose people to the virus, then the vaccine? Or both at the same time? Isn't a vaccine supposed to prevent infection rather than treat it?
Yes. They don’t give details, but I assume they would give the vaccine first.

They are using only younger adult volunteers, who in principle aren’t likely to have serious problem when they get it. Since there is a control group, presumably at least half the group will get it.

I see two obvious problems. The first is that recent evidence suggests that there are often long term problems even from mild cases. The second is that the population is intentionally different from those we are most concerned to protect.
 
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ReesePiece23

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Well, that's in direct violation of: The Traffic Light System, The 'R', The Rule of Six, The Three Tiers, Track and Trace, Social Bubbling, "Hands, Face, Space", Catch it, Bin it, The Five Tests, "Stay Home, Save Lives", Eat Out to Help Out, "Stay Alert, Control the Virus", Ready Steady Cover Your Face, Stop The Spread - Stay in Bed, "Stay Home >>Go On TikTok>>Dance Badly, and Build Back Better - with a calamitous no deal crash out.

But I remain optimistic.
 
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Human challenge studies: UK government signs contract for first clinical trials - CNN

Which is to say deliberately infecting volunteers to test therapies. A number of adjectives spring to mind. Stupid, dangerous and unethical are on top of my list.

My position has shifted somewhat.

While there are ethical challenges that seem problematic, we live in extraordinary times. COVID-19 is threatening entire countries economies and political stability in a way that common diseases do not.
 
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ReesePiece23

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Joking aside, my problem wouldn't be the virus - if I was confident about the concept of a vaccine, I'd gladly volunteer. But my problem IS the vaccine itself.

I am NOT an expert, but it's fair to say that vaccines take a good decade to get established. Correct?

So why should this be any different? (Genuine questions here.)
 
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sesquiterpene

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I am NOT an expert, but it's fair to say that vaccines take a good decade to get established. Correct?

So why should this be any different? (Genuine questions here.)
1.The pace of medical science is ever increasing. The virus was sequenced within weeks of discovery, and prototype vaccines were also available within a couple weeks, partly because:

2. They had already been working on vaccines for SARS and MERS for over a decade.
 
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ReesePiece23

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1.The pace of medical science is ever increasing. The virus was sequenced within weeks of discovery, and prototype vaccines were also available within a couple weeks, partly because:

2. They had already been working on vaccines for SARS and MERS for over a decade.

Good points. AND, I had completely forgotten about SARS and MERS.
 
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hedrick

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Joking aside, my problem wouldn't be the virus - if I was confident about the concept of a vaccine, I'd gladly volunteer. But my problem IS the vaccine itself.

I am NOT an expert, but it's fair to say that vaccines take a good decade to get established. Correct?

So why should this be any different? (Genuine questions here.)
Remember, in a challenge study half the people are controls. They don't get the vaccine. So even if you think the vaccine is perfect, there is a significant risk in being part of a challenge study, because you know you'll be infected, and there's a 50% chance you're not getting the vaccine.
 
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sesquiterpene

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Remember, in a challenge study half the people are controls. They don't get the vaccine. So even if you think the vaccine is perfect, there is a significant risk in being part of a challenge study, because you know you'll be infected, and there's a 50% chance you're not getting the vaccine.
One of the ways that these studies are justified is that they can use the same control group for multiple vaccine candidates - you might have five different experimental groups, placebo 20%, and 20% each for four different vaccines. There might be arguments from statisticians as to how to analyze this.
 
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hedrick

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One of the ways that these studies are justified is that they can use the same control group for multiple vaccine candidates - you might have five different experimental groups, placebo 20%, and 20% each for four different vaccines. There might be arguments from statisticians as to how to analyze this.
Yes, but you’d need to do them all at once, or there would almost certainly be differences in the populations of volunteers.
 
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sesquiterpene

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Yes, but you’d need to do them all at once, or there would almost certainly be differences in the populations of volunteers.
Yes, this needs a high level of coordination, which I'm not sure exists. The article in the OP doesn't mention which vaccines will be included, and I've only seen one company (AstraZeneca?) express an interest. No doubt I've missed some.
 
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hedrick

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I'm not sure I see the point. The vaccines are already going to be doing normal phase 3. The article says this will be a followup to get more specific data. But it seems it would likely miss many of the major issues:
* are there any problems that show up over time? And immediate challenge study won't show it
* how well do vaccines work with various different populations? But it seems like this is going to be one fairly homogeneous group

It would great to get more info on how kids respond to the vaccine, but I think the ethical problems with the challenge study would make that impossible.
 
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Trogdor the Burninator

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My position has shifted somewhat.

While there are ethical challenges that seem problematic, we live in extraordinary times. COVID-19 is threatening entire countries economies and political stability in a way that common diseases do not.

Well, at least it will stop the anti-vaxxers from arguing that "proper double blind testing wasn't done" or some such nonsense - because of course giving people potentially fatal diseases or viruses as part of vaccine trials should be just another day in science.

Oh who am I kidding - anti-vaxxers will just go on being stupid....
 
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sesquiterpene

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I'm not sure I see the point.
At the moment, there's so little information as to what is proposed that I can't tell what the benefits might be. I'd like to think that there are people designing trials that are better at this than me. And that is a real good bet.
 
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ThatRobGuy

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Well, at least it will stop the anti-vaxxers from arguing that "proper double blind testing wasn't done" or some such nonsense - because of course giving people potentially fatal diseases or viruses as part of vaccine trials should be just another day in science.

Oh who am I kidding - anti-vaxxers will just go on being stupid....

They'll just say the study was rigged, or the people got sick and they're just covering it up...

Blah blah blah something about 'big pharma'
Yada yada yada 'my chiropractor said...'
"look at this blog post I found by a doctor that says vaccines are poison" (zoom in to find that the credentials say "N.D." (Naturopathic "Doctor") instead of "M.D.")
 
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ThatRobGuy

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I saw an article about this earlier...

Based on what I read, they're using 18-30 (or maybe it was 18-35?) fully healthy young adults, with no pre-existing conditions.

So, statistically speaking, the group they're testing with would only have a tiny fraction of a fraction of a fraction of a chance of having some sort of severe outcome if exposed to the virus and the vaccine ended up not working.

Obviously there would be major ethical concerns with conducting a trial like that using a 65 year old with diabetes and a lung condition given what we know about it.

So I don't see anything wrong with the proposed study.

18-35 healthy people with no preexisting conditions are at a very very low risk of anything dire happening...

If a healthy 22 year old wants to take the risk of a low grade fever, stuffy nose, and cough for three to five days in the interest of speeding up a safe effective vaccine for everyone else (who may not be so lucky in terms of age and overall health)

...I say we thank their for their altruism, and let the study move forward.

When it comes to clinical trials, they're very choosy in terms of who they'll accept to minimize all potential risk.

I actually volunteered to participate in a clinical trial Cleveland clinic was conducting where they were looking for people who had tested positive on an antibody test.

Submitted my info, the two positive antibody test results from two different labs, the results of a physical (with full lipid and blood sugar panel taken within the last 120 days), etc...

Got shot down because on the questionnaire, it asked about family health history, and I have 2 grandparents who had heart attacks, and diabetes runs on my mom's side of the family.

So even though I'm a healthy 36 year old (active, good body weight, blood work came back great, liver function, the whole nine yards), got weeded out due to family health history.

So reputable medical institutions aren't going to just be trying this stuff out on people willy nilly. They're going to be trying to mitigate as much severe risk as humanly possible.
 
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Yes, this needs a high level of coordination, which I'm not sure exists. The article in the OP doesn't mention which vaccines will be included, and I've only seen one company (AstraZeneca?) express an interest. No doubt I've missed some.
Not sure if it'd be AZ - the vaccine they're involved with (ChAdOx1/AZD1222 - which was already in/close to testing as a MERS vaccine) has already been in phase 3 testing for some time.
 
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