Would you volunteer for CV-19 Clinical Trial?

[Moonlady]

Originally Posted by cjseliga

I just had my first visit for the AZD1222 (AstraZeneca/Oxford) Phase III clinical trial study.

There were 3 different waivers I had to sign, the 1st being 25 pages, the 2nd had 4 pages and the 3rd had 3 pages, I think. There's a 66.6% chance I got the vaccine and a 33.3% chance I got the placebo.

Being a so-called "vaccine-aholic", every vaccine, that I can remember getting in my lifetime, Tetanus/Tdap, Yellow Fever (2x), Flu shot (20x), HepA/B, etc. my arm is always sore for at least a day if not 2 or 3.

This time, nothing, zilch, nada, no pain, no redness, no soreness, which makes me believe I got the placebo. Supposedly for every country outside of the US, they are using a meningitis vaccine as their placebo, where as the US is just using saline.

If I did get the vaccine I would love to know what AstraZeneca did which didn't cause my arm to be sore and do that for all vaccines that I get!

I have a blood draw in 2 weeks, and then in 4 weeks, I get the second shot, then more blood draws after that, science!

Just curious - did they say that if a vaccine became available that they would unblind your study to know if you received the vaccine or not? That was my major concern going in - if I did get a placebo, I wanted to make sure that I could get an actual vaccine when it became available. As I understand it, the studies are double blind so only the person giving you the injection knows for certain. The study I had signed up for had a 2 year monitoring period.

[cjseliga]

Originally Posted by Moonlady

Just curious - did they say that if a vaccine became available that they would unblind your study to know if you received the vaccine or not? That was my major concern going in - if I did get a placebo, I wanted to make sure that I could get an actual vaccine when it became available. As I understand it, the studies are double blind so only the person giving you the injection knows for certain. The study I had signed up for had a 2 year monitoring period.

I didn't ask that, but thought the same thing. Most of the Phase 3 clinical trials are for 2 years, because they want to know the long term effects, and I knew that going in.

The interesting thing about SARS-CoV-2 and these vaccine clinical trials going on now, is that you can test to see if have the antibodies, basically knowing which group you are in, where as 99% of the other double blinded Phase 3 clinical trials for all the other new drugs out there, who can't do that.

Obviously, if they start rolling out the vaccine to the masses from the study you're in, it would be nice to get that vaccine if you are in the placebo group.

The thing with these studies, there is no binding contract, sure they want you to stay in them for the 2-year duration, but you can "opt-out" at any time. Lets say you're in a study and you do the antibody test and find out you got the placebo, and all these companies start rolling out these SARS-CoV-2 vaccines, just tell them you want to drop out and then go get the vaccine if you like!

But like you said, if it comes to that point, maybe they will stop the Phase 3 trial you are in and either give you the vaccine (if you didn't get) or you are free to get whichever vaccine you want then. The point I'm trying to make, there is no one holding a gun to your head making you stay in the trial.