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AstraZeneca [and other] vaccine trial experience

AstraZeneca [and other] vaccine trial experience

Old Nov 23, 20, 6:40 pm
  #1  
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AstraZeneca [and other] vaccine trial experience

As luck would have it, I had signed up for the AZ study and had my first in person visit today. I thought I would write a little "trip report", sharing the experience of driving to the next town over () for the study. For the purposes of this, I'll use vaccine to describe the shot I received as that's the language that was used in my visit. Of course, I have no idea at this point whether I received the study vaccine or a placebo.

Study Background
The study consists of the main study for the vaccine plus an optional genetic study to measure possible genetic markers to determine vaccine efficacy and COVID outcomes. The visits are the same whether you participate in the main or both studies and consist of the initial visit and vaccination (day 1), a phone call (8), second vaccination (29), phone call (36) and then follow-up visits at days 57, 90, 180, 360, 730. Blood will be taken at each visit, a nasal swab is taken at the initial visit; however, the nurse at the study site said it would only be processed if I report symptoms in the next few days. There is no other COVID testing unless I report symptoms.

If I report symptoms of COVID (fever, shortness of breath, difficulty breathing), then I will shift into the sick visit schedule which prompts a nasal swab, wearing of a home monitoring device, daily at home saliva collection, and in person visits with nasal swabs at days 14, 21, and 28

Today's Visit
My appointment was scheduled for 2:00pm and started right on time, however pre-visit beverages were not offered. I first had to fill out a few forms including contact details, health status, current medications, and a W9 for income reporting for study compensation (each in-person visit is paid at $125 and phone visits are $30).

After completing the initial round of paperwork, I was handed the 26 page study consent agreement that details the purpose of the study, what to expect, the study design, possible positive and negative outcomes, the dosing, visit and follow-up schedule, and how and what data will be collected and stored. There were approximately five others at my appointment time for the AZ study.

After reading the consent form, I was taken to an exam room to go through a detailed medical history review with the medical staff and electronically sign the consent agreement. There were lots of opportunities to ask questions. I asked the medical staff how the randomization worked and she said that each visit was randomized, meaning I could get the vaccine today and on my next visit, the placebo today and vaccine on my next visit, or visa-versa. I don't think that's accurate since the study protocol is measuring a two-dose course of the vaccine vs. placebo. In any case, from my reading of the study protocol (available here), the vaccine and placebo groups are randomized at a 2:1 ratio. I have a friend who is also in the study and she mentioned that should another vaccine get approval before the AZ vaccine, the placebo group will be vaccinated using that vaccine as a new control. That wasn't mentioned in my visit but was mentioned on the phone screening, so I'm not sure how that would work.

Next was collection of blood samples. They took three vials for antibody testing and the optional genetic study. Over the course of the study, they will take "88 teaspoons" of blood - what an odd unit of measurement. A nasal swab was also administered but, as I mentioned above, a COVID test will only be performed if I report COVID symptoms in the next "few days".

The site doctor then came in to do a very brief physical exam. He listened to my lungs, heart, and palpated my liver. Asked if I had ever been in a drug study before (I haven't) and said "if you feel like just a number, it's because you are." And then he left.

I then had to wait 30 minutes for the vaccine to sit out at room temperature. It was then injected, felt a bit longer than a flu shot, but I don't know if the volume was any different. A timer was set for 16 minutes and I was taken to the observation room to wait and make sure no immediate adverse reactions occurred. There were about seven people in the waiting room over the time I was there.

Finally, a reminder to download the study reporting app where I log my COVID symptoms, and then they handed me an envelope with my loaded Visa gift card to receive my study payments.

It's now about three hours later and I feel fine. A doctor at my wife's clinic is also in the study and reported rigors, fever, chills, and malaise the day after his first vaccination. Of course, I would like to feel something but I don't think I want to feel really awful so we'll see how the next day goes.

Edit:
I should probably also mention that there was a separate sub-study that more frequently monitored for SARS-CoV-2 infection. That study is now full (I think it was 3,000 total participants). In the sub-study, there are more in-person visits (at days 1, 15, 29, 43, 57, 90, 180, 360, 720). A COVID naval swab will be performed at each in-person visit as well as blood samples for "seasonal CoV" (not sure what that is). I presume the purpose of the sub-study is to measure the vaccines effectiveness at preventing infection in addition to preventing disease.

Last edited by TTT; Nov 23, 20 at 8:15 pm
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Old Nov 24, 20, 12:53 am
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Originally Posted by TTT View Post
As luck would have it, I had signed up for the AZ study and had my first in person visit today. I thought I would write a little "trip report", .
Thanks! Since this is flyertalk I have a travel related question.

I'm sure by now you've heard that Qantas is going to require a vaccine passport, and I'm sure many other airlines/countries will follow also.

By being part of this study, I'm assuming on day 720 or whatever you'll be told "you were given a real vaccine not a placebo". Is that correct, or will you never find out? If you did get a real vaccine, how will you get the proper proof documentation so that you can take a Qantas flight in the future do you know / was this covered or discussed at all?

Since you mentioned that the study followups run till day 720 does that mean you can not allowed to take a real vaccine if one becomes available before then (if you got a placebo), which means you won't realistically be able to go to countries requiring a vaccine till da 720?
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Old Nov 24, 20, 3:11 am
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Originally Posted by TTT View Post
It's now about three hours later and I feel fine. A doctor at my wife's clinic is also in the study and reported rigors, fever, chills, and malaise the day after his first vaccination. Of course, I would like to feel something but I don't think I want to feel really awful so we'll see how the next day goes..
Many thanks for taking the time to write that up, it's very interesting. But thank you, too, for your service here. If we get over this pandemic it will thanks to people like you who have taken on this important responsibility, to help humanity.

Originally Posted by nomiiiii View Post
Since you mentioned that the study followups run till day 720 does that mean you can not allowed to take a real vaccine if one becomes available before then (if you got a placebo), which means you won't realistically be able to go to countries requiring a vaccine till da 720?
It is mentioned in the report in respect of switching vaccines, but the standard protocol in this area is that people who volunteer for testing should not be disadvantaged. So if this or another vaccine is recommended to the OP, s/he wil be allowed to go ahead with that if they wish (and if you think about it, from a voluntary point of view it would be impossible to prevent anyway). As you can see, this study generates a wealth of information and even if there is a handbrake turn in the middle the OP's data will remain valuable. If the USA works like the UK, the rollout of vaccines will be a bit like boarding call. So group 1 boarding first, then boarding group 1 and group 2, and so on. So the OP's medical boarding card may be a little way down the process in terms of timing, and thus gives more information to the University of Oxford team.

There is also a separate provision where if the evidence is so overwhelming, for ethical reasons the placebo group will get fast tracked for the proper vaccine.
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Old Nov 24, 20, 3:30 am
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Originally Posted by TTT View Post
....

Edit:
I should probably also mention that there was a separate sub-study that more frequently monitored for SARS-CoV-2 infection. That study is now full (I think it was 3,000 total participants). In the sub-study, there are more in-person visits (at days 1, 15, 29, 43, 57, 90, 180, 360, 720). A COVID naval swab will be performed at each in-person visit as well as blood samples for "seasonal CoV" (not sure what that is). I presume the purpose of the sub-study is to measure the vaccines effectiveness at preventing infection in addition to preventing disease.
Every vaccine trial should have been doing that, this is critical. I mean what's the point otherwise, a job half done...

Moderna's chief medical officer says that vaccine trial results only show that they prevent people from getting severely sick not necessarily that recipients won't still be able to transmit the virus
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Old Nov 24, 20, 4:29 am
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Originally Posted by nk15 View Post
They have done this deliberately to ensure large effect sizes in the analysis. None of the trials will measure the degree to which candidate vaccines reduce viral transmission or mortality, although you can reasonably suspect a reduction in symptomatic cases to lead to a reduction in mortality (but this is not guaranteed by any means).

https://www.bmj.com/content/371/bmj.m4058

We've had the hygiene theatre/er. Watch this space for the vaccine theatre/er...
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Old Nov 24, 20, 7:01 am
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Originally Posted by nomiiiii View Post
Thanks! Since this is flyertalk I have a travel related question.

I'm sure by now you've heard that Qantas is going to require a vaccine passport, and I'm sure many other airlines/countries will follow also.

By being part of this study, I'm assuming on day 720 or whatever you'll be told "you were given a real vaccine not a placebo". Is that correct, or will you never find out? If you did get a real vaccine, how will you get the proper proof documentation so that you can take a Qantas flight in the future do you know / was this covered or discussed at all?

Since you mentioned that the study followups run till day 720 does that mean you can not allowed to take a real vaccine if one becomes available before then (if you got a placebo), which means you won't realistically be able to go to countries requiring a vaccine till da 720?
Great questions. I don't have specific answers, but I know the following:
  • I am free to leave the study at any time and for any reason
  • At some point it is unethical to keep a placebo group on a placebo for a potentially lethal disease if there are drugs that offer protection

I also mentioned that there was some reference to the placebo group being vaccinated with whatever vaccine becomes approved and using that as the control. With that, I might assume that should the AZ or other vaccine receive some level of approval that the placebo group will be notified and vaccinated. At that point, the vaccine group would probably be informed as well.

I'd love to hear other's thoughts though as that isn't specifically mentioned in the information I have. It would be interesting to also know if I leave the study, am I informed of what I received? I would think they might tell me but I don't know for sure.

Edit: In any case, I could always get an antibody test in 6 months and make a decision then. If I was antibody negative, assume I'm in the placebo group and get another vaccine should it be available.
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Last edited by TTT; Nov 24, 20 at 7:25 am
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Old Nov 24, 20, 7:09 am
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Originally Posted by nk15 View Post


I agree. I believe this sub-study is where AZ made the inference of some sterilizing immunity in their press release.

Additionally, there was a fascenating discussion on TWiV last week on the persistance of immunity where they discussed this pre-print. Immunological memory to SARS-CoV-2 assessed for greater than six months after infection

This very discussion was brought up and the virologist from that paper has some ideas as to whether the Moderna and/or Pfizer would provide steralizing immunity based on the immune responses they trigger - he seemed to think they would but couldn't say for sure. In any case, it seems logistically it would be hard to mandate weekly Covid testing for participants though that wouldn't be an insurmountable challenge.

TWiV 684: Persistence of SARS-CoV-2 immune memory (discussion starts at 47 minutes and goes for about an hour).
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Old Nov 24, 20, 7:21 am
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Originally Posted by TTT View Post

I agree. I believe this sub-study is where AZ made the inference of some sterilizing immunity in their press release.

Additionally, there was a fascenating discussion on TWiV last week on the persistance of immunity where they discussed this pre-print. Immunological memory to SARS-CoV-2 assessed for greater than six months after infection

This very discussion was brought up and the virologist from that paper has some ideas as to whether the Moderna and/or Pfizer would provide steralizing immunity based on the immune responses they trigger - he seemed to think they would but couldn't say for sure. In any case, it seems logistically it would be hard to mandate weekly Covid testing for participants though that wouldn't be an insurmountable challenge.

TWiV 684: Persistence of SARS-CoV-2 immune memory (discussion starts at 47 minutes and goes for about an hour).
(Bolding above mine) I agree, I think they sacrificed comprehensiveness for speed (and to save resources, or they did not have them, or preferred to spend them on recruiting more people), in order to be among the first that had a good vaccine on the primary outcome of interest.
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Old Nov 24, 20, 7:22 am
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Vaccine Update (FWIW):
Yesterday around 7:00pm I started to feel a little nauseous but am not sure if it was the leftover chili I had for dinner, my mind playing tricks, or the vaccine. The nausea persisted most of the night and I dozed a bit until my wife got home around 1:00am. We chatted for a bit but right at 2:00am I was hit pretty abruptly with large muscle aches in the lower back, legs, and shoulders. It felt like an illness but without the other stuff (cough, stuffy nose, fever). I took some Tylenol and dozed on the couch until 5:30am and then went back to bed and slept pretty well for an hour or so.

It's now 7:20am and the nausea is still there a bit but muscles aren't sore now (other than the jet lagged feeling of poor sleep on the couch). The injection site is not sore at all. I'm curious to see how I feel the rest of the day. If I received the vaccine, this is would be one of the more intense reactions I've had to vaccines as I usually tolerate them well.
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Old Nov 24, 20, 8:01 am
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Originally Posted by TTT View Post
It's now 7:20am and the nausea is still there a bit but muscles aren't sore now (other than the jet lagged feeling of poor sleep on the couch). The injection site is not sore at all. I'm curious to see how I feel the rest of the day. If I received the vaccine, this is would be one of the more intense reactions I've had to vaccines as I usually tolerate them well.
They chose the placebo to give some similarity with the actual vaccine's side effects, and if you got the MenB placebo your symptoms are on the list of side effects. There again, these side effects are quite rare with MenB, it is usually just lethargy and muscle punch.

Hope you get to full strength very quickly.
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Old Nov 24, 20, 8:04 am
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Originally Posted by corporate-wage-slave View Post
They chose the placebo to give some similarity with the actual vaccine's side effects, and if you got the MenB placebo your symptoms are on the list of side effects. There again, these side effects are quite rare with MenB, it is usually just lethargy and muscle punch.

Hope you get to full strength very quickly.
Thanks! I'm sure I'll feel back to normal soon.

Actually, in this study the placebo is saline. This is from my informed consent document:
The vaccine can give you side effects that will be explained below. The placebo is made up of salt water.
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Old Nov 24, 20, 8:09 am
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Originally Posted by TTT View Post
Thanks! I'm sure I'll feel back to normal soon.

Actually, in this study the placebo is saline. This is from my informed consent document:
Ah, well,the side effects from saline aren't usually in that category! I think someone said that in some places they couldn't use MenB due to uninsurable "external risks" (i.e. legal ramifications). I know Arizona was in this category.
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Old Nov 24, 20, 9:14 am
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Originally Posted by TTT View Post
Vaccine Update (FWIW):
Yesterday around 7:00pm I started to feel a little nauseous but am not sure if it was the leftover chili I had for dinner, my mind playing tricks, or the vaccine. The nausea persisted most of the night and I dozed a bit until my wife got home around 1:00am. We chatted for a bit but right at 2:00am I was hit pretty abruptly with large muscle aches in the lower back, legs, and shoulders. It felt like an illness but without the other stuff (cough, stuffy nose, fever). I took some Tylenol and dozed on the couch until 5:30am and then went back to bed and slept pretty well for an hour or so.

It's now 7:20am and the nausea is still there a bit but muscles aren't sore now (other than the jet lagged feeling of poor sleep on the couch). The injection site is not sore at all. I'm curious to see how I feel the rest of the day. If I received the vaccine, this is would be one of the more intense reactions I've had to vaccines as I usually tolerate them well.
I have huge respect for you and all the trial participants who have volunteered for vaccine trials. Without you there would be no vaccine so thank you and I hope you feel better soon.

Your experience mirrors others I know who have been involved in a ChAdOx1 nCov-19 trial. There is no way of knowing which arm you are in but if you are in a study with saline placebo, it's likely you were in the experimental arm. Anecdotally, moderate reactions do seem to be a feature of the ChAdOx1 nCov-19 vaccine thought to be due to how immunogenic the spike protein is. I believe the mRNA platforms also had this effect but exogenous RNA is also a potent inflammatory stimulus in itself. Interestingly, adverse effects seem to be fewer in older people which makes sense as they are likely to have a less "brisk" immune response (but I won't ask you to reveal your age!)
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Old Nov 24, 20, 9:27 am
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Originally Posted by doctoravios View Post
Anecdotally, moderate reactions do seem to be a feature of the ChAdOx1 nCov-19 vaccine thought to be due to how immunogenic the spike protein is. I believe the mRNA platforms also had this effect but exogenous RNA is also a potent inflammatory stimulus in itself. Interestingly, adverse effects seem to be fewer in older people which makes sense as they are likely to have a less "brisk" immune response (but I won't ask you to reveal your age!)
I thought about including my age and am happy to reveal - I'm latter half of mid-30s, male. I imagine the vector vaccine is also prompting an immune response, perhaps compounding the side effects.

Interestingly, I read through some of the study protocol and the site vaccine administrator actually doses the syringe with either locally sourced saline or from the vaccine vial, based on the randomization software's output; they are not blinded. I had no interaction with the vaccine administrator other than to receive the injection. This process may be common for studies but I would have thought everyone at the site was blinded.
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Old Nov 24, 20, 9:33 am
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Originally Posted by TTT View Post
I thought about including my age and am happy to reveal - I'm latter half of mid-30s, male. I imagine the vector vaccine is also prompting an immune response, perhaps compounding the side effects.

Interestingly, I read through some of the study protocol and the site vaccine administrator actually doses the syringe with either locally sourced saline or from the vaccine vial, based on the randomization software's output; they are not blinded. I had no interaction with the vaccine administrator other than to receive the injection. This process may be common for studies but I would have thought everyone at the site was blinded.
Yes, I believe most of the phase III COVID-19 vaccine trials are single blinded. I guess this is to reduce costs of preparing a comparable placebo, which for deep-frozen mRNA candidates could be substantial. It shouldn't affect outcomes as long as there is no conferring between vaccine administrator and participant and I am sure they have been emphatically told they must not do this.
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