For people who are curious about what clinical trials look like from the guinea pig's point of view – a first look at the Novavax trial that I’ve just joined. First, I'll declare my background - I've been on both sides of a trial (30 years back) and also just on the guinea pig side before - but always in much more leisurely, non-pandemic circumstances, without the need for masks, social distancing or involving the sheer volume of volunteers/medical personnel being used over a short period.
The trial centre they were using was the sport’s hall of a leisure centre. Big car park and lots of space indoors – ideal for the job really. The venue was set up as series of stations/zones that you go through in sequence. We’d already completed an online questionnaire and had a telephone interview, and received a trial information pack to read a few days before the session. The appointment is for a specific start time – the whole thing took around 2 hours with no waiting, other than those implicit in the process (like the vaccine warm-up time and the monitoring period)
What did the trial say it would do if a vaccine gets approved?
If it’s approved and available (to your age group etc) – then you can ask for your status in the vaccine trial – placebo or vaccine. If you’re in the placebo group, then you’ll be advised to go and get the approved vaccine. If you’re in the vaccine group, they’ll give you the choice – and give you whatever efficacy and other data they’ve got as guidance.
What happens in the trial group after the Day 0 start?
A checkup, to review side effects, give you another jab, and do a couple of bloodtests etc, 3 weeks after jab1.
A checkup 2 weeks after the second jab, including a bloodtest and a review of any side-effects/health changes.
A checkup 3 months after the second jab.
A checkup 6 months after the second jab.
A checkup 12 months after the second jab.
What if you get covid symptoms, serious side effects or some major health change happens?
You have a phone number for the team doctors, they give immediate advice on what to do and arrange for a follow-up appointment.
An email address in case you want to send them any new information.
Incidentally, the trials are just as labour intensive as they sound. It takes a lot of resources to run a trial.
The trial centre they were using was the sport’s hall of a leisure centre. Big car park and lots of space indoors – ideal for the job really. The venue was set up as series of stations/zones that you go through in sequence. We’d already completed an online questionnaire and had a telephone interview, and received a trial information pack to read a few days before the session. The appointment is for a specific start time – the whole thing took around 2 hours with no waiting, other than those implicit in the process (like the vaccine warm-up time and the monitoring period)
First stop, right on the door – a temperature check, a mask change (they want you to wear their disposables) and a quick “do you have any symptoms”, “have you met anyone who has tested positive recently.” Then on to the next stop.
Reception – they get your name, and give you your personal documentation pack, and a pen, that you’ll be wandering around with.
Consent – they were working on small groups of volunteers, up to 6 at a time (all socially distanced) etc. The group listen to one of the trial leads explaining the basics of the trial, how the vaccine works, what the trial is looking for (side effects, efficacy) and the role of the placebo/blind trial, side effects observed so far (and typical side effects of vaccines) and what they’ll do if another vaccine gets approved and rolled out (in your age group or whatever) before the trial completes. Also a chance to ask questions – though it looked like the group I was in had already read the paperwork.
Medical history – we were then sent to our next station, 6 doctors at 6 well-distanced tables, doing the one to one interviews. More questions to check on obvious safety hazards (allergies, autoimmune disease etc – that might mean they don’t put you in the trial) + a general set of questions on pre-existing medical conditions/medicines/or food supplements etc, that were mostly gathered for info/reporting rather than for exclusion purposes.
Medical – the same doctor then gives you a basic checkup, working on you in a screened booth assigned to that doctor. Temperature, blood pressure, pulse O2, height/weight, a stethoscope to listen to the heart/lungs, a look into the throat and a manual inspection of the glands in the neck. A final chance to ask any questions, express any worries, add any undocumented comments/background you think of to the file – and a final go, no-go from you and the doctor.
The test and vaccination – Another desk and a different nurse or doctor. Another couple of checks on allergies/current symptoms etc. They collect a blood sample, then do a (swab) covid test and give you an explanation of how to do a covid test on yourself. They also gather together all the paperwork including the consent form, crosscheck the numbers and get it copied. If you’re going ahead with the jab – they request a dose for you (to the dispensing staff working behind a partitioned area at the back of the room - to help preserve the placebo/vaccine blinding). Twenty minutes later (to give it time to reach room temperature) – you get the jab – name, patient ID and vaccine code get cross checked.
Monitoring – they send you to the comfy (socially distanced) chairs to wait for half an hour. One of the nurses tries to keep you entertained by offering you bottled water and packets of biscuits. They give you a bag containing your copy of your signed consent, a patient ID card (with your patient code and the trial team phone numbers etc), three Covid test kits, a thermometer, and a ruler (in case they want you to measure a rash). They give you a reminder to phone the trial doctors if side effects are worrying or you get covid symptoms and help you register in a clinical trials reporting app. Finally, a check on your pulse O2, blood pressure, temperature – to check they’re back to (your) normal.
Checkout – a final desk where you get schedule your appointment for the next mini-medical and second jab.
Reception – they get your name, and give you your personal documentation pack, and a pen, that you’ll be wandering around with.
Consent – they were working on small groups of volunteers, up to 6 at a time (all socially distanced) etc. The group listen to one of the trial leads explaining the basics of the trial, how the vaccine works, what the trial is looking for (side effects, efficacy) and the role of the placebo/blind trial, side effects observed so far (and typical side effects of vaccines) and what they’ll do if another vaccine gets approved and rolled out (in your age group or whatever) before the trial completes. Also a chance to ask questions – though it looked like the group I was in had already read the paperwork.
Medical history – we were then sent to our next station, 6 doctors at 6 well-distanced tables, doing the one to one interviews. More questions to check on obvious safety hazards (allergies, autoimmune disease etc – that might mean they don’t put you in the trial) + a general set of questions on pre-existing medical conditions/medicines/or food supplements etc, that were mostly gathered for info/reporting rather than for exclusion purposes.
Medical – the same doctor then gives you a basic checkup, working on you in a screened booth assigned to that doctor. Temperature, blood pressure, pulse O2, height/weight, a stethoscope to listen to the heart/lungs, a look into the throat and a manual inspection of the glands in the neck. A final chance to ask any questions, express any worries, add any undocumented comments/background you think of to the file – and a final go, no-go from you and the doctor.
The test and vaccination – Another desk and a different nurse or doctor. Another couple of checks on allergies/current symptoms etc. They collect a blood sample, then do a (swab) covid test and give you an explanation of how to do a covid test on yourself. They also gather together all the paperwork including the consent form, crosscheck the numbers and get it copied. If you’re going ahead with the jab – they request a dose for you (to the dispensing staff working behind a partitioned area at the back of the room - to help preserve the placebo/vaccine blinding). Twenty minutes later (to give it time to reach room temperature) – you get the jab – name, patient ID and vaccine code get cross checked.
Monitoring – they send you to the comfy (socially distanced) chairs to wait for half an hour. One of the nurses tries to keep you entertained by offering you bottled water and packets of biscuits. They give you a bag containing your copy of your signed consent, a patient ID card (with your patient code and the trial team phone numbers etc), three Covid test kits, a thermometer, and a ruler (in case they want you to measure a rash). They give you a reminder to phone the trial doctors if side effects are worrying or you get covid symptoms and help you register in a clinical trials reporting app. Finally, a check on your pulse O2, blood pressure, temperature – to check they’re back to (your) normal.
Checkout – a final desk where you get schedule your appointment for the next mini-medical and second jab.
What did the trial say it would do if a vaccine gets approved?
If it’s approved and available (to your age group etc) – then you can ask for your status in the vaccine trial – placebo or vaccine. If you’re in the placebo group, then you’ll be advised to go and get the approved vaccine. If you’re in the vaccine group, they’ll give you the choice – and give you whatever efficacy and other data they’ve got as guidance.
What happens in the trial group after the Day 0 start?
A checkup, to review side effects, give you another jab, and do a couple of bloodtests etc, 3 weeks after jab1.
A checkup 2 weeks after the second jab, including a bloodtest and a review of any side-effects/health changes.
A checkup 3 months after the second jab.
A checkup 6 months after the second jab.
A checkup 12 months after the second jab.
What if you get covid symptoms, serious side effects or some major health change happens?
You have a phone number for the team doctors, they give immediate advice on what to do and arrange for a follow-up appointment.
An email address in case you want to send them any new information.
Incidentally, the trials are just as labour intensive as they sound. It takes a lot of resources to run a trial.
