Covid Vaccine Trial - First VisitJune 26, 2020
Oxford university is running a phase II/III trial for their vaccine (ChAdOx1 nCoV-19 - hereafter CHAD). I heard about it on Twitter and decided to apply for the trial back in March/April time. I’d previously done a trial for the same organisation in Oxford investigating new ways to infect people with malaria (no really), and I was used to the idea of clinical trials.
I’ve decided to do a few posts chronicling my experiences in case anything happens, and also because I find it interesting to note the differences in normal hospital care vs during a pandemic.
A couple of weeks/a month after applying to be on the trial I received calls from an unknown number. The second one I actually picked up (not my normal policy) and they invited me to go to a screening appointment for the vaccine trial. They wanted me in the next day at a convenient place in London.
I arrived a couple of minutes early, hospital was open as normal apart from:
- Facemasks being given out on entry (Along with mandatory hand wash)
- Lifts had 4 person capacity limit
- My temperature was taken and noted when I moved between different parts of the hospital (unclear why not on entry)
- All receptionists were behind perspex screens.
- Mask usage was around 90%, though some staff were eating and talking in the corridors without masks.
- Staff very keen to know why I was there - suspect they didn’t want people wandering around. My normal experience with hospitals is that you can more or less walk in most of the time.
- Screening was in an outpatients area and I was taken to a room with a doctor straight away. Doctor had mask off in the room but put it on as I approached.
- They were keen to know where I lived and if I’d used public transport to get there (I walked). There was a short debate as to whether that was okay, as they wanted me to come in to the hospital if I was sick for some tests. (Why not use a private ambulance in that case? Perhaps they already had enough participants and could be picky?)
- Briefly went through the study documentation (which I’d read beforehand). Answered my question about immune overreaction in some SARs vaccines - what I view as the main risk of taking part. Doctor seemed to think the main risk was a neurological condition.
- Then on to consent forms. They wanted to keep all my blood forever and do what they wanted with it. Also wanted to use it as a serum for commercial purposes if they wanted. These parts were optional.
- Medical history - the standard stuff, as well as some family history. My anxiety + sertraline medication didn’t bother them. Took temperature (only time I lowered my mask so the probe could go in my mouth).
- Measured height/weight/blood pressure. Interestingly they had one machine to do all three, but the blood pressure wasn’t well calibrated and they had to measure with a different machine to get the true result.
- Took a venous blood sample, testing for HIV, Hep A/B/C and COVID antibodies.
- Hygiene pretty good throughout, though doctor’s mask kept falling off and we passed a pen around without washing our hands. All surfaces wiped down after we’d touched them (e.g. blood pressure cuffs).
- Paperwork somewhat out of date and whole thing slightly rushed, but that was understandable.
The study lacked a unified place to have all it’s data - I was enrolled in the portal of the hospital itself, as opposed to one for the study itself.
- Some of the data wouldn’t even be available there, as it would go to Public Health England. Shockingly, they wouldn’t get the PHE results unless I told them (the explanation was that it was easier to do it that way and they’re trying to move as quickly as possible).
Clarifications from the paperwork:
- Study is aiming for at least 20k participants in the UK, paperwork indicated up to 10k. Doctor said they only really needed 4k to get the statistical power they needed, but wanted more to test various things.
- I asked why they didn’t do a challenge study and they said that Oxford wanted to, but was hamstrung by ethics constraints. They said a couple of challenge studies had been done on very sick elderly patients but were inconclusive. A challenge study might happen but probably only in the 18-25 age group, which might not be enough to validate the vaccine.
- The groups 1-6 stuff mentioned on the paperwork was confusing, but I’m in group 6 which is a larger dose, and only for healthy adults.
- Pending results of the blood sample testing negative for COVID antibodies, they will vaccine me with CHAD or with a meningitis vaccine this week.