11 ms·

I'm in the trial. Here's the participant information sheet, in case anyone's curious: https://drive.google.com/file/d/1WB5QPmECchlThnem9wcX0PDaKQWtmUgZ/view?usp

I'm in the trial. Here's the participant information sheet, in case anyone's curious: https://drive.google.com/file/d/1WB5QPmECchlThnem9wcX0PDaKQWtmUgZ/view?usp=sharing https://drive.google.com/file/d/1WB5QPmECchlThnem9wcX0PDaKQW...

mromanuk 6y ago
at what point you know (or will know) if you were given a placebo or the actual vaccine?
- garmaine 6y ago
  when the trial is ended.
  - xxs 6y ago
    ...or in this case if you get infected with the real thing as medical history is important.
- Bobblebobble 6y ago
  At the end of the study.
erikrothoff 6y ago
Are you given any monetary compensation or compensation at all for joining the trial?
- Bobblebobble 6y ago
  Yes, they pay a small amount and cover travel expenses.
- eznzt 6y ago
  From TFPDF: >You will be compensated for your time, the inconvenience of having blood tests and procedures, and your travel expenses. The total amount compensated will be approximately £235 - £625 depending on the exact number of visits and whether any repeat or additional visits are necessary.
  - SamBam 6y ago
    To add some context to this, medical trials generally only compensate time (at a low hourly rate) and expenses, occasionally increased slightly to compensate for hardship. They deliberately do not pay large amounts, because the money is not supposed to overly-incentivize the participation, to avoid ethical issues where someone might choose to participate in something very unsafe only because the reward seems so large.
    - xnyan 6y ago
      I did various medial trials in college for money and have mixed feelings about this. When sitting in the various waiting rooms, it was very clear that was only one kind of person that did "open" (not targeting people with a disorder but rather recruiting healthy volunteers) medical trials: the poor. I got to know lots of of people well (we were frequent flyers in the medical trial world), and our common characteristic was that we really needed the money. It's kind of like non-pay electoral offices. You only get candidates that can afford not to work. In medical trials, you get the kind of people that are willing to, for example, get infected with the common cold and have you blood drawn 6x a day for 4 days for about 80 bucks a day. It was not horrible, but often uncomfortable. Study recruiters still call me, and now that I have a decent paying job there is no way I would ever consider doing those kinds of studies again. Simply not worth it.
      - TheKarateKid 6y ago
        Exactly my thoughts. Hardly anyone from these groups is doing it “for science.” It’s for money. Thinking otherwise is willful ignorance, and this is clearly exploitation of lower income groups.
      - kortilla 6y ago
        The problem is increasing the reward makes the people “who need the money” much more willing to engage in trials with much worse possible side effects. As long as the pay isn’t life altering money for anyone, nobody will volunteer to do something with a high probability of life altering side effects.
teagee 6y ago
does anyone have a similar info sheet for the US trial?
eznzt 6y ago
Thank you very much for sharing this. >Until now, this vaccine has only been tested on laboratory mice and other animal species and this is the first time that the vaccine will be given to humans. Is it possible to know which species those are?
- kn0where 6y ago
  Don’t personally know but usually it’s monkeys.
- Bobblebobble 6y ago
  It has been tested on rhesus macaque monkeys.
  - mikeyouse 6y ago
    Yep, more detail here: https://www.nih.gov/news-events/news-releases/investigational-chadox1-ncov-19-vaccine-protects-monkeys-against-covid-19-pneumonia https://www.nih.gov/news-events/news-releases/investigationa...
fcsp 6y ago
Considering all the excluded groups on the trial (page 3, kids, 55+, obese, weak immune system, a lot more), it's a lot of exclusions, how does one get from results on a study like this to declaring the vaccine safe for general use?
- bun_at_work 6y ago
  Not really qualified to answer this, but I would imagine follow-on rounds of testing. Also, those groups should be protected through herd immunity if everyone else gets the vaccine.
- refurb 6y ago
  Extrapolation. Is there a scientific rationale as to why the vaccine would NOT be safe and effective in a new population? If not, approve it for that population. If there is rationale why it wouldn’t be, ask for more data.
  - bosie 6y ago
    Why would the reasons used to exclude those cohorts in the first place not be used to determine the vaccine is unsafe for said cohorts?
    - refurb 6y ago
      Noise in the data and ethics. Noise in the data - you want as clean a population as you can get. If you start including people with chronic conditions, as soon as someone in your trial dies you get to play a game called "prove that it wasn't the vaccine that killed them". Same with people over 55 years old - they are known to respond differently to vaccines. The worst thing in the world would be showing a 49.4% reduction in Covid infection rate (the FDA wants 50% minimum) and then being forced to do a bunch of handwaving about how your results were skewed by the 55+ patients in your study and "by gosh, I swear it would be over 50% if we adjust for them using this methodology we just made up". Nobody will believe you and you'll be relegated to "that vaccine that almost works". Ethics - Kids aren't (well, very rarely) dying from Covid, but they could die after getting your experimental vaccine. Kids sickened by experimental drugs makes for bad press, not only you, but also the FDA. Easier to just exclude them for now.
lifeisstillgood 6y ago
I think this is the apex of the HN effect - usually it's finding a world expert answering your question ... but we can beat that :-) And thank you for volunteering.
- qwertox 6y ago
  It's really a special place in the internet.
ilyagr 6y ago
I'm surprised they don't seem to do frequent and regular COVID testing of participants to catch asymptomatic infections. Naively, it would seem worthwhile in order to predict how well the vaccine would slow down the spread. I guess the reason is that the study is narrowly tailored to vaccine approval requirements?
- sjg007 6y ago
  It’s a pipe dream. We don’t have enough capacity. People won’t get tested either. This issue would be mute if people wore masks and stayed apart.
  - BenjiWiebe 6y ago
    *moot
  - ilyagr 6y ago
    More than 300000 people a day get tested for coronavirus in the UK according to [1], and the testing capacity is even greater than that. This is enough to cover study participants. I would imagine that volunteers would also be willing to get tested, though perhaps the worry is that such a requirement might cause more of them to drop out of the study. [1]: https://interactive.news.sky.com/2020/covid-19-coronavirus/tests-uk-barchart/index.html https://interactive.news.sky.com/2020/covid-19-coronavirus/t...
- mathw 6y ago
  The study is tailored to the standards of vaccine approval, of course it is. They need to prove safety and efficacy, so they design a trial which will allow those factors to be measured. Kind of difficult to prove efficacy if you don't know how many people in your trial were infected with the disease you're trying to vaccinate against though. But do bear in mind as mentioned in other comments this participant was not in the phase 3 trial, and phase 3 is where the immunity given by a vaccine is tested. Phase 1 and phase 2 are much more constrained studies intended to determine if it's safe to give the vaccine to enough people to evaluate immunity.
ixtli 6y ago
Thank you so much for volunteering.
Dig1t 6y ago
ChAd to the rescue!
- pageandrew 6y ago
  Virgin SARS-CoV- 2 vs Chad ChAdOx1
goldenkey 6y ago
Thank you for volunteering - an indubitably priceless service to humanity.
- vinay427 6y ago
  And yet there's a price on it. ;) https://news.ycombinator.com/item?id=24897311 https://news.ycombinator.com/item?id=24897311

mromanuk 6y ago

at what point you know (or will know) if you were given a placebo or the actual vaccine?

garmaine 6y ago
when the trial is ended.
- xxs 6y ago
  ...or in this case if you get infected with the real thing as medical history is important.
Bobblebobble 6y ago
At the end of the study.

erikrothoff 6y ago

Are you given any monetary compensation or compensation at all for joining the trial?

Bobblebobble 6y ago
Yes, they pay a small amount and cover travel expenses.
eznzt 6y ago
From TFPDF: >You will be compensated for your time, the inconvenience of having blood tests and procedures, and your travel expenses. The total amount compensated will be approximately £235 - £625 depending on the exact number of visits and whether any repeat or additional visits are necessary.
- SamBam 6y ago
  To add some context to this, medical trials generally only compensate time (at a low hourly rate) and expenses, occasionally increased slightly to compensate for hardship. They deliberately do not pay large amounts, because the money is not supposed to overly-incentivize the participation, to avoid ethical issues where someone might choose to participate in something very unsafe only because the reward seems so large.
  - xnyan 6y ago
    I did various medial trials in college for money and have mixed feelings about this. When sitting in the various waiting rooms, it was very clear that was only one kind of person that did "open" (not targeting people with a disorder but rather recruiting healthy volunteers) medical trials: the poor. I got to know lots of of people well (we were frequent flyers in the medical trial world), and our common characteristic was that we really needed the money. It's kind of like non-pay electoral offices. You only get candidates that can afford not to work. In medical trials, you get the kind of people that are willing to, for example, get infected with the common cold and have you blood drawn 6x a day for 4 days for about 80 bucks a day. It was not horrible, but often uncomfortable. Study recruiters still call me, and now that I have a decent paying job there is no way I would ever consider doing those kinds of studies again. Simply not worth it.
    - TheKarateKid 6y ago
      Exactly my thoughts. Hardly anyone from these groups is doing it “for science.” It’s for money. Thinking otherwise is willful ignorance, and this is clearly exploitation of lower income groups.
    - kortilla 6y ago
      The problem is increasing the reward makes the people “who need the money” much more willing to engage in trials with much worse possible side effects. As long as the pay isn’t life altering money for anyone, nobody will volunteer to do something with a high probability of life altering side effects.

teagee 6y ago

does anyone have a similar info sheet for the US trial?

eznzt 6y ago

Thank you very much for sharing this. >Until now, this vaccine has only been tested on laboratory mice and other animal species and this is the first time that the vaccine will be given to humans. Is it possible to know which species those are?

kn0where 6y ago
Don’t personally know but usually it’s monkeys.
Bobblebobble 6y ago
It has been tested on rhesus macaque monkeys.
- mikeyouse 6y ago
  Yep, more detail here: https://www.nih.gov/news-events/news-releases/investigational-chadox1-ncov-19-vaccine-protects-monkeys-against-covid-19-pneumonia https://www.nih.gov/news-events/news-releases/investigationa...

fcsp 6y ago

Considering all the excluded groups on the trial (page 3, kids, 55+, obese, weak immune system, a lot more), it's a lot of exclusions, how does one get from results on a study like this to declaring the vaccine safe for general use?

bun_at_work 6y ago
Not really qualified to answer this, but I would imagine follow-on rounds of testing. Also, those groups should be protected through herd immunity if everyone else gets the vaccine.
refurb 6y ago
Extrapolation. Is there a scientific rationale as to why the vaccine would NOT be safe and effective in a new population? If not, approve it for that population. If there is rationale why it wouldn’t be, ask for more data.
- bosie 6y ago
  Why would the reasons used to exclude those cohorts in the first place not be used to determine the vaccine is unsafe for said cohorts?
  - refurb 6y ago
    Noise in the data and ethics. Noise in the data - you want as clean a population as you can get. If you start including people with chronic conditions, as soon as someone in your trial dies you get to play a game called "prove that it wasn't the vaccine that killed them". Same with people over 55 years old - they are known to respond differently to vaccines. The worst thing in the world would be showing a 49.4% reduction in Covid infection rate (the FDA wants 50% minimum) and then being forced to do a bunch of handwaving about how your results were skewed by the 55+ patients in your study and "by gosh, I swear it would be over 50% if we adjust for them using this methodology we just made up". Nobody will believe you and you'll be relegated to "that vaccine that almost works". Ethics - Kids aren't (well, very rarely) dying from Covid, but they could die after getting your experimental vaccine. Kids sickened by experimental drugs makes for bad press, not only you, but also the FDA. Easier to just exclude them for now.

lifeisstillgood 6y ago

I think this is the apex of the HN effect - usually it's finding a world expert answering your question ... but we can beat that :-) And thank you for volunteering.

qwertox 6y ago
It's really a special place in the internet.

ilyagr 6y ago

I'm surprised they don't seem to do frequent and regular COVID testing of participants to catch asymptomatic infections. Naively, it would seem worthwhile in order to predict how well the vaccine would slow down the spread. I guess the reason is that the study is narrowly tailored to vaccine approval requirements?

sjg007 6y ago
It’s a pipe dream. We don’t have enough capacity. People won’t get tested either. This issue would be mute if people wore masks and stayed apart.
- BenjiWiebe 6y ago
  *moot
- ilyagr 6y ago
  More than 300000 people a day get tested for coronavirus in the UK according to [1], and the testing capacity is even greater than that. This is enough to cover study participants. I would imagine that volunteers would also be willing to get tested, though perhaps the worry is that such a requirement might cause more of them to drop out of the study. [1]: https://interactive.news.sky.com/2020/covid-19-coronavirus/tests-uk-barchart/index.html https://interactive.news.sky.com/2020/covid-19-coronavirus/t...
mathw 6y ago
The study is tailored to the standards of vaccine approval, of course it is. They need to prove safety and efficacy, so they design a trial which will allow those factors to be measured. Kind of difficult to prove efficacy if you don't know how many people in your trial were infected with the disease you're trying to vaccinate against though. But do bear in mind as mentioned in other comments this participant was not in the phase 3 trial, and phase 3 is where the immunity given by a vaccine is tested. Phase 1 and phase 2 are much more constrained studies intended to determine if it's safe to give the vaccine to enough people to evaluate immunity.

ixtli 6y ago

Thank you so much for volunteering.

Dig1t 6y ago

ChAd to the rescue!

pageandrew 6y ago
Virgin SARS-CoV- 2 vs Chad ChAdOx1

goldenkey 6y ago

Thank you for volunteering - an indubitably priceless service to humanity.

vinay427 6y ago
And yet there's a price on it. ;) https://news.ycombinator.com/item?id=24897311 https://news.ycombinator.com/item?id=24897311