Note: The studies currently being run here are regular Phase 3 trials, not challenge trials, so you don't have to be young or perfectly healthy to sign up.
Also, for any trial, they fully explain everything and you can leave at any time. Just signing up doesn't commit you to actually getting vaccinated if you change your mind later.
Not sure about these two points conflicting. You will not be infected but if you do we will help you get care.
Volunteers will not be exposed to the SARS-CoV-2 virus as part of the study. These are studies of preventive vaccines that we hope will keep people healthy.
If you become infected with SARS-CoV-2 and become ill with COVID-19, the study staff will work with you to make sure you get the care that you need.
They mean if you get it in the real world, they will be working with your doctors because they will want to run tests to determine why the vaccine didn't prevent the infection. As a side benefit, you might get slightly more attention and better care.
> they will want to run tests to determine why the vaccine didn't prevent the infection.
The answer to which could be as simple as "they were given the placebo"
Presumably if you're uninsured, they get you medical insurance. Testing drugs on uninsured people then leaving them untreated if they get ill during the study would be a bit cold, even for the american medical industry.
Eh, the cynic in me doesn’t think this is out of benevolence so much as it is to make sure they collect the best data possible. People without health insurance have worse outcomes because they forgo or delay necessary treatment.
Makes sense. It wouldn't really be ethical to do so with an unproven vaccine (and it was proven, this trial wouldn't be necessary).
If they do the trial in large enough numbers, many participants will get exposes in their normal lives anyway. I assume they will target hotspot areas.
I think the idea is, if you take the vaccine, and either it doesn't work, or before it works, you contract COVID-19 separately, they will help treat you.
Cool, I would definitely join if it wasn't US only :(
Even though I'm 'high risk' I'm not that worried about the virus myself, and I feel some higher risk than normal actions are necessary to protect people and to go back to our normal world ASAP.
Also, I assume it's good to have some not perfectly healthy individuals in the mix as they would probably be more likely to experience side-effects.
It does say they will expand their reach beyond the US though so that might be good news.
There are studies underway in other countries (e.g. Germany or the UK) as well, and they are also looking for volunteers (though often not as openly). Where are you located?
The one I know of is in Germany, and I only know of it through an acquaintance who is involved in the study. They're now looking for people for Phases 2 and 3. The job-ad for potential participants doesn't mention anything about COVID, though. I'm assuming this is either due to legal reasons, or something along the lines of "we want people to go into this unbiased". In any case, the wording is pretty general, something along the lines of "looking for participants in a clinical study for vaccinations. Applicants must not have contracted covid19 before".
He might even be willing to test out whether it works by intentionally getting exposed (human challenge study) so that he can then go club and drink at the pub etc.
I'm quite happy to let him go first, because I'd rather let someone else be the first person who has purple tentacles grow from their nipples, or whatever other nasty side effect this may turn out to have. There's a reason we do these trials.
This is the first time I hear about these folks so I'm not sure about how good this study is but AFAIK Moderna, from the US just like this study, were starting phase 3 tests with their medicine already. The more the better I guess? Here in Brazil as of early this month Sinovac (from China) started accepting health workers volunteers for their 9000 people phase 3 tests across the country. Just today, as you know, Oxford announced promising results too but in fact they had been already testing people with their vaccine in phase 3 tests last month here (5000 people from multiple covid epicenters). I would really love to know when we could expect to have minimal first results. Everybody got really happy with the results of phase 2 and all but I suppose the first data for phase 3 will be decisive whether we can build up REAL expectations or not. Somehow, sometimes, it also feels these folks are all racing for a Nobel prize more than anything else.
From this page, it sounds like they are mostly looking for people who are likely to encounter the virus, and are in high risk groups:
("For some of the antibody studies, you will not need to reach out to a site because the study staff will come to the nursing home or assisted living facility."):
If you are in the general area of Seattle, Kaiser is looking for people who might be interested in volunteering for studies. They included this in a recent email to Kaiser members:
> The Kaiser Permanente Washington Health Research Institute, which is currently leading a study for a COVID-19 vaccine, is seeking volunteers in the Seattle area to sign up for a COVID-19 vaccine registry. If you sign up and qualify, you may be called and asked whether you'd like to participate in a future trial. Learn more about the registry.
The "Learn more about the registry" was a link that ends up at [1].
Requirements to be registered are at least 18 years old, in good health or with stable medical conditions, live in the greater Seattle area, and can travel to the Kaiser Permanente Washington Health Research Institute clinic in downtown Seattle for multiple study visits. No need to be a KP member.
As someone very pro-vaccine, what are the risks of doing this? Is the worst case scenario you get the vaccine and not a placebo and it does nothing? Are there real health risks to doing this?
Vaccines in general have the potential to produce what's known as "antibody-dependent enhancement", where the disease will be even worse for you than if you didn't have a vaccine. Researchers don't think this is a factor for coronavirus vaccines, but if they're wrong it wouldn't have been detected in phase 1 and 2 studies.
Is there a standard set of potential side effects?
Lets say some of these potential vaccines are effective at producing an immune response enough to provide protection from Covid infection, is there a level of side effects that would cause a vaccine to fail clinical trials?
The podcast Science Vs. described one patient who received an experimental vaccine and had severe (but not life-threatening) fever-like side effects including fainting, nausea/vomiting, chills, and lethargy/weakness:
> When I woke up, I woke up this was at noon the next day, I had to get up to go to the bathroom, on the way there I felt really nauseous and actually ended up throwing up in the bathroom and then I just collapsed. I remember waking up on the floor, though, and looking up and seeing the underside of the kitchen table, which was a very confusing sight
So by taking an experimental vaccine you're risking these sorts of side effects. In this particular study there were 45 participants and 3 had severe side effects of this nature.
Not sure what people find interesting about this? Phase 3? I got a (test) vaccine this month not with this company. No idea on phase.
Interesting things I thought -
You might get the placebo. (No idea for Phase 3)
It was done by a generic testing company, as expected.
About minimum wage for time in hospital, probably pick a trial that's over night and quicker(C19 was 400 days and you can't do other trails) for better money.
Everyone is the cliche test subject (I mixed with other trials), backpackers and students and dodgy people.
We got generic info about trials, overnights (not for C19) had warnings about bring porn, bag searches and no bed sharing, which made overnight trials sound fun.
Given the wide range of questions, there would be a lot of lying to get admittance I would guess.
Drug tests each time you go in.
Double birth control is required, not sure the nurses even expected that to actually happen when they questioned you.
A lot of money is spent when you're bored and look around and start doing the $ being spent.
I'm very locked down, so interesting I volunteered for a challenge study but not this one (as I am unlikely to catch covid so a bad fit). The ideal group here are people at high risk of getting it.
39 comments
[ 3.1 ms ] story [ 88.1 ms ] thread[1] https://www.nih.gov/news-events/news-releases/nih-launches-c...
I'm not in the US but it says they might expand soon so I may just register anyway (I'm sure they ask where you live).
Volunteers will not be exposed to the SARS-CoV-2 virus as part of the study. These are studies of preventive vaccines that we hope will keep people healthy.
If you become infected with SARS-CoV-2 and become ill with COVID-19, the study staff will work with you to make sure you get the care that you need.
The answer to which could be as simple as "they were given the placebo"
Presumably if you're uninsured, they get you medical insurance. Testing drugs on uninsured people then leaving them untreated if they get ill during the study would be a bit cold, even for the american medical industry.
If they do the trial in large enough numbers, many participants will get exposes in their normal lives anyway. I assume they will target hotspot areas.
That is a thing that people do sometimes:
https://en.wikipedia.org/wiki/Human_challenge_study
There has been a debate about also doing it with COVID-19:
https://en.wikipedia.org/wiki/COVID-19_vaccine#Proposed_chal...
Even though I'm 'high risk' I'm not that worried about the virus myself, and I feel some higher risk than normal actions are necessary to protect people and to go back to our normal world ASAP.
Also, I assume it's good to have some not perfectly healthy individuals in the mix as they would probably be more likely to experience side-effects.
It does say they will expand their reach beyond the US though so that might be good news.
https://youtu.be/2I2PjLna4C0 .
If you're down, do it, then get an antibody test after the fact.
He might even be willing to test out whether it works by intentionally getting exposed (human challenge study) so that he can then go club and drink at the pub etc.
I'm quite happy to let him go first, because I'd rather let someone else be the first person who has purple tentacles grow from their nipples, or whatever other nasty side effect this may turn out to have. There's a reason we do these trials.
Hey, some people are into that.
[1]https://www.nhs.uk/conditions/coronavirus-covid-19/research/...
https://mobile.twitter.com/thesundaytimes/status/12695146159...
("For some of the antibody studies, you will not need to reach out to a site because the study staff will come to the nursing home or assisted living facility."):
https://www.coronaviruspreventionnetwork.org/what-to-expect-...
> The Kaiser Permanente Washington Health Research Institute, which is currently leading a study for a COVID-19 vaccine, is seeking volunteers in the Seattle area to sign up for a COVID-19 vaccine registry. If you sign up and qualify, you may be called and asked whether you'd like to participate in a future trial. Learn more about the registry.
The "Learn more about the registry" was a link that ends up at [1].
Requirements to be registered are at least 18 years old, in good health or with stable medical conditions, live in the greater Seattle area, and can travel to the Kaiser Permanente Washington Health Research Institute clinic in downtown Seattle for multiple study visits. No need to be a KP member.
[1] https://corona.kpwashingtonresearch.org/
Lets say some of these potential vaccines are effective at producing an immune response enough to provide protection from Covid infection, is there a level of side effects that would cause a vaccine to fail clinical trials?
> When I woke up, I woke up this was at noon the next day, I had to get up to go to the bathroom, on the way there I felt really nauseous and actually ended up throwing up in the bathroom and then I just collapsed. I remember waking up on the floor, though, and looking up and seeing the underside of the kitchen table, which was a very confusing sight
So by taking an experimental vaccine you're risking these sorts of side effects. In this particular study there were 45 participants and 3 had severe side effects of this nature.
Full transcript: https://docs.google.com/document/d/e/2PACX-1vQ78hrs4ldf6abmA... Episode: https://gimletmedia.com/shows/science-vs/dvh28wk/coronavirus...
Interesting things I thought -
You might get the placebo. (No idea for Phase 3)
It was done by a generic testing company, as expected.
About minimum wage for time in hospital, probably pick a trial that's over night and quicker(C19 was 400 days and you can't do other trails) for better money.
Everyone is the cliche test subject (I mixed with other trials), backpackers and students and dodgy people.
We got generic info about trials, overnights (not for C19) had warnings about bring porn, bag searches and no bed sharing, which made overnight trials sound fun.
Given the wide range of questions, there would be a lot of lying to get admittance I would guess.
Drug tests each time you go in.
Double birth control is required, not sure the nurses even expected that to actually happen when they questioned you.
A lot of money is spent when you're bored and look around and start doing the $ being spent.