Pogue Mahone
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Vaccine clinical trials - guinea pig's eye view - part 2.
Novavax trial. 21 days after jab 1 (of something), it's time to return to base for jab 2 (of something). The trial is based in the sports centre again - the sports hall is kitted out with a series of socially distanced stations - laid out as a numbered circuit of activities, you stick to your table number loop as you move.
Summary: a brief medical - as with jab1 day this is actually a longer "hands on" physical checkup than I've had from a GP in the past 30 years- medical history, any changes in medications/conditions, any after effects from jab 1. A trip to the nurse to get jab 2. A stay in observation, with another check of bp, pulse O2, temperature, vaccination site then release.
Front door - a new (disposable) mask as they prefer you to wear theirs, a temperature check, and "have you had any symptoms, met anyone who has tested positive?"
Reception - check-in, they give you your paperwork to carry round with you.
Introduction - a brief status report to the group in your timeslot on the trial from one of the senior trial doctors and a chance for questions. Mostly focused on the question, "what if I get a call to go for a (real) vaccine" again.
Doctor - go to your numbered station to see your doctor. Quick checkup of bp, temperature, pulse O2. Medical history update, including any changes. Any reactions to the jab. Physical checkup (in screened privacy booth) concentrating on lymph nodes, but with a quick "no changes" look at other things. A final check that you're willing to continue the trial.
Nurse - next numbered station. There's a pause now, while you wait for your jab to warm up (the vaccine is kept in the fridge) and dispensed in a screened pharmacy area. We had a nice chat and then it was jab time. Dose labels, name date of birth, patient number, checked by pharmacist, nurse and second nurse. Again, I don't actually feel the vaccination at all, there's not really even any mark beyond a tiny pinprick dot of blood.
Observation - 30 minutes in the comfy chair, with the coffee and biscuits. Choice of biccies available today I got the lemon cream. Another nurse checks your bp, pulse O2, temperature and asks how you're feeling, and makes sure you've still got your covid test kits at home and that the app is on your phone. Then you're done.
Appointments - book your next session in 14 days for a checkup
What's striking from the guinea pig side is just how smooth and professional the whole thing feels - and how seriously they take their responsibility for the volunteers. It's slick, the only pauses/waits are part of the trial - wait for the jab to warm up because it's in the fridge, then wait in observation - and that gives you time to talk to doctor for longer, or chat with the nurses as you wait together. It's also very labour intensive, which is a reminder why "normal" clinical trials don't get done this fast. They require lots of funding, clinical support and volunteers.
The staff are clearly enjoying the trial (as odd as that might sound). They believe in what they're doing. They're also very aware of what they aren't doing. One of the nurses I spoke to is normally involved in new cancer treatment trials, but has spent most of the year dealing with covid patients and then later with covid treatment trials on hospitalised patients. The vaccines come as a huge relief to them and running the trial has given them a boost.
And me? Well I don't know what I got - placebo or vaccine. I had a pain in the injected muscle after jab 1 (not bad, but enough that I couldn't sleep on that side on that first night). Same again after jab2, but for a couple of nights. Placebo or vaccine - it's an injection into the deltoid muscle (high on the arm) - maybe I just don't like them at all, maybe it's a coincidence. It won't change anything in my behaviour but obviously I hope I had the vaccine. I'll happily admit that I've become bizarrely committed to the Novavax vaccine - I want it to be the +90% efficacy, fridge storage, low side-effect vaccine of choice! But who knows.
What’s the placebo in this study? Saline? Or an active substance?