UPDATE: my Phase 3 COVID19 vaccine trial experience

DogBunny

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One week ago, I became a trial participant in a Phase 3 COVID19 vaccine study, and got a shot in my arm. There is a 50/50 chance that I either got the test vaccine or placebo.

I am testing the Johnson & Johnson/Janssen Pharmaceuticals vaccine candidate. The basis of their vaccine is significantly different from the two vaccines that you hear the most about in the news, the Moderna and Pfizer vaccines. If you are interested in the top 5 major U.S. vaccine candidates, a nice, very succinct summary of them can be read here:
https://labblog.uofmhealth.org/rounds/top-5-covid-19-vaccine-candidates-explained

I signed up to be a test candidate way back in April or so. At that time, I was pretty freaked out by the virus. We didn’t know how deadly it was or wasn’t. I figured that a 50/50 chance that I might get a vaccine that might save my life was better than nothing.

The reason that it took so long for me to get a call-back is because J&J has just now started Phase 3 with volunteers who are over 60, which is me.

The J&J vaccine only uses a single shot. I got a nice little monetary compensation, but that’s not why I enrolled.

I have to fill out a one-question questionnaire twice a week. The question is “do you have signs of COVID19”. I have to return to the clinic five times in the next year for blood draws and physicals. Each time, I get compensated. I think the study continues for another year after that.

Last Sunday was a combination of Visit 1 and Visit 2. Visit 1 is screening, and Visit 2 is the administration of the shot. It was supposed to take about 3-1/2 hours, but the clinic was short-staffed, and they had some computer problems, so I was there for about 5 hours. During which I was injected, inspected, detected, infected, neglected and selected (bonus points to everyone who gets that). Actually, it was mostly just waiting around. The only unpleasantness was that I was given a nasal swab, in order to make sure that I didn’t already have the virus. The swab was “only” inserted about an inch in each nostril. Maybe I’m somehow susceptible, but it felt like I’d been punched in the face for about 5 minutes. Some of the other nasal swab tests go 2-1/2” in. I told the clinic person that I’d have to be anaesthetized before getting one of those. In any case, not having to get a nasal swab is one more reason that you should try to avoid getting the virus.

I had pretty much absolute zero reaction to the shot that I received. This leads me to believe that I received placebo. The Moderna and Pfizer vaccines commonly cause well-publicized reactions. However, the J&J vaccine is a different technology, and I don’t know if it typically causes a reaction or not. So, I really don’t know what I got.

Anyone else out there in a Phase 3 COVID19 vacine study?
 

kshansen

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During which I was injected, inspected, detected, infected, neglected and selected (bonus points to everyone who gets that). Actually, it was mostly just waiting around. The only unpleasantness was that I was given a nasal swab, in order to make sure that I didn’t already have the virus.

Were there any glossy pictures with writing on them and notes on the back?
 

DogBunny

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That's the vaccine that's dangerous to pregnant women, so I hope it was a placebo!
Where did you hear that? I couldn't find anything saying that the J&J vaccine, also known as the Janssen vaccine, is dangerous to pregnant women. To the contrary, this vaccine is an AD26-based vaccine, which is what the Ebola vaccine is, and the Ebola AD26-based vaccine is safe for pregnant women.

In any case, I'm not currently pregant, nor is there very much likelihood that I'll become so. Either way, I hope that I did NOT receive placebo. This vaccine, if it works, has a couple of advantages over the Pfizer and Moderna vaccines. It can be stored in a normal refrigerator, and it only requires one shot. So, I'm hoping that it is a success.
 

YamadudeXS650C

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Sounds like the J and J vaccine works. Will they ever tell you if you got the vaccine or the placebo?
The latest reports on the J&J vaccine is that it is only 66% effective in preventing moderate disease, the poorest result of all the current vaccine's. I would rather not receive it, if I had the choice.

I don't think that any participants in clinical trials are ever told what injection they received, and are informed of this ahead of time..
 
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GLJ

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Just heard 60% ish on the J&J
One dose, regular refrigeration.
I read everywhere from the 60s to mid 80s. It has been mentioned that it does not seem to be as effective against the African variant.

I don't think that any participants in clinical trials are ever told what injection they received, and are informed of this ahead of time..
That kinda sucks.
 

YamadudeXS650C

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I read everywhere from the 60s to mid 80s. It has been mentioned that it does not seem to be as effective against the African variant.


I don't think that any participants in clinical trials are ever told what injection they received, and are informed of this ahead of time.
That kinda sucks.
This is the nature of volunteering to be a clinical trial participant, which is why it is regarded to be a courageous personal commitment.
 

YamadudeXS650C

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I would think when the trial is over they would tell you so if you got the placebo you could get protected.
To the best of my knowledge, drug experiments are not regarded to be "over" within any particular time period, since psychological (or placebo) factors are involved, but some may vary from this, I imagine.
 

Jim

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RE the J&J vaccine: Dr. Jha was just on the ABC Evening News. Said it's 66% eff. in preventing covid. 85% eff. in preventing severe cases, and %100 eff. in preventing hospitalization and death. I'll take those odds.
 

jetmechmarty

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RE the J&J vaccine: Dr. Jha was just on the ABC Evening News. Said it's 66% eff. in preventing covid. 85% eff. in preventing severe cases, and %100 eff. in preventing hospitalization and death. I'll take those odds.
I’d take them too! The latest study shows vaccine by fire (getting sick) most effective, but speaking from experience, I don’t recommend it.
 
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