3 ms·

Covid-19: World's first human trials given green light in UK

23 points by BellLabradors 6y ago

BellLabradors 6y ago
More information: https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk https://www.gov.uk/government/news/worlds-first-coronavirus-...
- twoslide 6y ago
  Interesting, it implies that unvaccinated young people will be exposed to the virus in order to establish minimum levels of exposure required for infection. The BBC article is very poorly written, and based on it I assumed they were vaccinated (and also, I couldn't really see the point).
m12k 6y ago
I'm hoping this can answer some questions regarding how covid infection works. For example, are you less likely to have severe illness if the infection starts somewhere other than the lungs? How does the infection spread in the body, and is there any way to help prevent the neurological infection and cognitive side effects that have been reported? (loss of smell, loss of balance, reduced cognition and memory). If there's a way to consistently cause an infection that doesn't come with severe primary or secondary effects (cytokine storm in the lungs or organ/nerve damage) could that be used as a way to inoculate the younger part of the population while vaccine supplies are still scarce?
- iguy 6y ago
  And, does the severity of your case depend strongly on your dose? This could have been extremely interesting early on. If it turned out that (say) severe cases in young people required a huge does, then it might have been possible to "vaccinate" everyone under 40 by only-just infecting them.
iguy 6y ago
Title should (IMO) contain "human challenge". Most vaccine trials have involved humans, but none have involved deliberate exposure, i.e. "challenge". Seems crazy this took so long. Why didn't this happen last summer?
- cameronh90 6y ago
  Maybe the treatments and risk data for Covid in youth back then weren't good enough to be sure of the ethics of this study?
- twoslide 6y ago
  Definitely needs "challenge" - of course there have been many "human trials."
- mchusma 6y ago
  I was a huge proponent of challenge studies in April-September 2020. Now I don't really see the point except to build some sort of institutional process to try and make them more feasible in the next pandemic. Moderna's vaccine was developed in Jan 2020 and in human trials in March 2020. Most of this death could have been avoided if we only could figure out how to un-ban vaccines faster. We need new approaches. COVID was a regulatory disaster more than a biological one. Incorporating human challenge trials into the mix of things is a good thing.
  - tzs 6y ago
    I doubt that early human challenge trials would have speed up vaccine development much, if at all. You still need the non-challenge trials to determine that a proposed vaccine is safe and effective in a large diverse population, and those are what took most of the time. HCT trials involve people who we are either pretty sure won't get seriously ill from the virus being tested or pretty sure we can successfully treat if they do get seriously ill. That generally means subjects who are young adults in good health with no known conditions that might put them at extra risk (and early into a new disease, we don't know what those conditions might be, so you really want to limit your early HCT to young adults in near perfect health). The general population is full of people from children to the elderly, ranging in health from Captain America territory to Mr. Burns territory, with a plethora of already existing diseases and conditions. Testing in that limited demographic that qualifies for an early HCT just doesn't tell you much about the safety or effectiveness of your vaccine for everyone else.

23 points by BellLabradors 6y ago

More information: https://www.gov.uk/government/news/worlds-first-coronavirus-human-challenge-study-receives-ethics-approval-in-the-uk https://www.gov.uk/government/news/worlds-first-coronavirus-...

twoslide 6y ago
Interesting, it implies that unvaccinated young people will be exposed to the virus in order to establish minimum levels of exposure required for infection. The BBC article is very poorly written, and based on it I assumed they were vaccinated (and also, I couldn't really see the point).

m12k 6y ago

I'm hoping this can answer some questions regarding how covid infection works. For example, are you less likely to have severe illness if the infection starts somewhere other than the lungs? How does the infection spread in the body, and is there any way to help prevent the neurological infection and cognitive side effects that have been reported? (loss of smell, loss of balance, reduced cognition and memory). If there's a way to consistently cause an infection that doesn't come with severe primary or secondary effects (cytokine storm in the lungs or organ/nerve damage) could that be used as a way to inoculate the younger part of the population while vaccine supplies are still scarce?

iguy 6y ago
And, does the severity of your case depend strongly on your dose? This could have been extremely interesting early on. If it turned out that (say) severe cases in young people required a huge does, then it might have been possible to "vaccinate" everyone under 40 by only-just infecting them.

iguy 6y ago

Title should (IMO) contain "human challenge". Most vaccine trials have involved humans, but none have involved deliberate exposure, i.e. "challenge". Seems crazy this took so long. Why didn't this happen last summer?

cameronh90 6y ago
Maybe the treatments and risk data for Covid in youth back then weren't good enough to be sure of the ethics of this study?
twoslide 6y ago
Definitely needs "challenge" - of course there have been many "human trials."
mchusma 6y ago
I was a huge proponent of challenge studies in April-September 2020. Now I don't really see the point except to build some sort of institutional process to try and make them more feasible in the next pandemic. Moderna's vaccine was developed in Jan 2020 and in human trials in March 2020. Most of this death could have been avoided if we only could figure out how to un-ban vaccines faster. We need new approaches. COVID was a regulatory disaster more than a biological one. Incorporating human challenge trials into the mix of things is a good thing.
- tzs 6y ago
  I doubt that early human challenge trials would have speed up vaccine development much, if at all. You still need the non-challenge trials to determine that a proposed vaccine is safe and effective in a large diverse population, and those are what took most of the time. HCT trials involve people who we are either pretty sure won't get seriously ill from the virus being tested or pretty sure we can successfully treat if they do get seriously ill. That generally means subjects who are young adults in good health with no known conditions that might put them at extra risk (and early into a new disease, we don't know what those conditions might be, so you really want to limit your early HCT to young adults in near perfect health). The general population is full of people from children to the elderly, ranging in health from Captain America territory to Mr. Burns territory, with a plethora of already existing diseases and conditions. Testing in that limited demographic that qualifies for an early HCT just doesn't tell you much about the safety or effectiveness of your vaccine for everyone else.