H7N9 Influenza Vaccine Trial: Being a Guinea Pig for Science

So I came across a COVID-19 Vaccine Trial:

"Velocity Clinical Research... is looking for healthy participants that have a passion for research and a dedication to help fight COVID. We have a phase 1 COVID-19 vaccine trial... This vaccine is created using a plant based approach."

That was interesting, so I signed up. The ad I saw didn't mention the age range, which was 18 to 49, so, being 53, I didn't qualify.

As a consolation prize, the fellow who contacted me said they were doing a trial on a bird flu vaccine, for which I qualified.

OK, so I signed up for that one instead.

Probably a good thing that I wasn't getting a "plant based" COVID-19 vaccine, whatever the heck that means!

So happily this is not the first test of this vaccine: "Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults."

"All adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9% versus 23.2%, 28.6%, and 17.2 for the nonadjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the nonadjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination."

Well, I'm not suicidal, or a masochist, so this looked reasonable to see from the inside what a vaccine trial looks like.

This is a seriously dangerous virus, compared to SARS-CoV-2.  It's far less contagious, so far, but far more lethal, with a case fatality rate in the 40% range. Yikes! Up until 2020, this was considered one of the prime candidates for a serious pandemic virus, which is why they are developing a vaccine for it.

The trial I seem to be in is this one:

"A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older."

I say "seem" because at the time I went to the office and found out the details (April 7), this study was listed as "not recruiting", which surprised the physician who saw me, as she said it had been recruiting for a while. It was updated yesterday, however, and now says it is recruiting guinea pigs. Typical bureaucratic SNAFU, in other words. The information that Velocity provided to me suggested going to the clinicaltrials.gov site to look up the details, but didn't provide any information by which one could identify the trial. However this is the only one listed for H7N9. Sigh. 

At any rate, they were all quite surprised that I had actually looked up the trial, and had read the results of the previous trial, and was fully briefed on what was going on. I guess no one does this.

Dry hole.

So I went to the office on the 7th and went through the process. 

1. Fill out the paperwork, including a medical history, read the disclaimer information and then go through the process of them making sure I'm actually willing to be a guinea pig.
2. Answer some further questions about my medical history, and get a basic physical. I'm apparently quite healthy, and, most importantly, have no auto-immune diseases, and am not on any immune-suppressing drugs, which I gather would have been disqualifying. Allergies and asthma don't count.
3. Get a blood draw. Took three tries to get a good draw, but I think the first person to try this wasn't too good at it, the second person had no problem.
4. Get the vaccine. There are 7 arms to this trial, and only one is the placebo, so it's an 86% chance (6 in 7) that I got something injected.
5. Go sit in the observation room to see if I grow a third arm or something.

Much to my surprise, I did have a little bit of a reaction to the shot. They injected the vaccine (86% likely) into my right deltoid (shoulder) muscle, and shortly thereafter, I got a mild shooting pain lower down in my arm. I got a few more joint pains around my body, but most noticeable, I got pretty spacey. Not dizzy, but spaced out.

So the physician came out and chatted with me for a few minutes, and decided I was well enough, and sent me on my way. I stopped by a store, and forgot my phone number. Whoops!

But I was well enough. Got a tiny bit of a headache too, but that went away quickly enough.

Running cures what ails you!

Went for a run in the afternoon, and was fine after that.

The joint pains and headache are expected reactions to the injection, btw, so no worries so far.

So now I have to keep a diary each day, and take my temperature—they gave me a digital thermometer for this, which is good, because I don't know where mine is.

Oddly, my temperature has been just above 99F, including before they gave me the shot. 100.4F was their cutoff for a fever, so that didn't disqualify me.

No reaction at the injection site, it's just a tiny bit sore if I press on it, which is typical for any vaccination, but not nearly so bad as a tetanus shot, for instance.

No reactions at all after the first day.

Study protocol. They skipped the pregnancy test.

I have to keep the diary for seven days, then go back for a second shot in a couple of weeks, then follow up by phone to see if I'm still alive for several months after that. The whole trial lasts 13 months.

Oh, they do pay a nominal amount for participating in the trial, and they will cover your medical expenses if you get sick from the shot.

This also means that I am not allowed to get a COVID-19 vaccination for a couple of months, as that would ruin this experiment.

Since I was already either infected or exposed to COVID, I'm not worried about that, especially since the risk to me of being seriously ill with COVID is minute.

Amusingly, they gave me a COVID-19 surveillance form, to see if I come down with COVID-19.

"But the symptoms are the same as the flu", I observed.

"Yes, we know."

So I'll find out in 13 months what they did to me.

P.S. Follow-up 1.