novavax vaccine trial - anyone else?

[Frazzled2207]

Have just had the call and am going tomorrow. Very excited. Anyone else doing this?

There's an article i read in BBC new. Basically some countries donate a certain amount of money to ensure that the poorest countries will be able to vaccinate their vulnerable. If you look in the Corona section on bbc news app it may still be there.

Bit late to the party here! Had my first appointment today, the clinic was busy with a lot of waiting between each section. Tried to get a sneaky look at the colour of the injection but it was completely covered by a sticker. Was quite surprised at the lack of any system for reporting side effects, was told I only have to fill in the app if I have any Covid symptoms. Currently feel completely fine so am convinced I had the placebo!

@Maiyakat - by the sounds of it I think the vast majority on this thread have had the placebo

@Maiyakat I was surprised too. I think it's because by the time they get to phase 3 they're only looking for serious adverse events, otherwise it's all about efficacy.

I've been looking at the Pfizer vaccine stats. It's interesting. 95% of people on the trial who contracted COVID were in the control group, 5% had the vaccine. But there's too many confounding variables for that to mean that it's 95% effective - not everyone on the trial has the same level of exposure to the virus.

andadietcoke - but it is randomised so on average the exposure of people in both groups is the same. So the statisticians plug all the variables in and work out the numbers needed so that they can be confident in what they see.

I'm convinced I had the vaccine. Quite strong reaction 24 hours/48 hours afterwards.

I must admit I don't really understand how it all works with the statistics and exposure to Covid.

So the third visit I presume they will take blood and then look for antibodies?

They are doing Phase 3 trials for the Oxford vaccine at a hospital a few miles from me, so I have been pondering on whether to take part or not. I have started a separate thread about that, but am very inspired by this thread.

I'm a bit anxious about what is involved - 6 to 8 appointments over 12 months or more. It's quite a commitment in some ways (well, more than just the 2 or 3 appointments I imagined, to have a screening appt and 2 jabs). The traffic near the hospital is awful and parking is expensive - I wonder if they might give free parking for trial participants? I'm also a bit wary about being inside the hospital at all - in my mind it's Covid central! So, on a selfish note I am telling myself not to put myself in line for all the aggro, but part of me does want to do my bit, especially as I have been made redundant and feel a bit useless right now.

Thanks for everyone taking part in this trial....I'm a clinically extremely vulnerable health care professional and I'm currently working from home on this trial doing remote data entry for trial- we have already recruited over 400 patients in a few days at our site, which is incredible !....my colleagues and I are working round the clock and putting in many extra hours work to run this trial so it's refreshing to hear so many reassuring stories and hope that trial leads to a positive outcome ... medical research is a fascinating ( and often frustrating) area in which to work

@BG2015 hope you're feeling back to normal now. Yes, third appointment is bloods. Mine is tomorrow so I'll report back!

There was free parking at the trial location I went to. It was a pay and display car park but they gave me a pass to put in my car.

@Stopyourhavering64
Nice to hear from the other side!
I asked upthread and maybe you can help... I was saying there must be a vast amount of data input needed. Obviously I am pleased you have something to do which you can do from home but what is the reason for the mountains the paperwork and why can this not all be inputted electronically in the first place? Is it just lack of hardware? And presumably it slows down all the results. Not a criticism just would like to understand

@Defenbaker - our trial will pay reasonable travel expenses so they should pay for your parking. If it's any comfort you are unlikely to be anywhere near any Covid patients. At my first appointment I was in the medical school, and there were no patients around at all, just impossibly young looking med students!

My second appointment is tomorrow, I will report back on anything interesting...

@Defenbaker
It’s great to help in a small way. Your specific fears might be unfounded though. The hospital running our trial is not actually seeing us at the hospital. They have set up in a rugby club of all places with plenty of space and parking etc and is easy to get to. All appointments are there. So don’t assume the appointments will be at the hospital running the trial for starters! They will want to make the process as convenient as possible for those taking part.

[quote Frazzled2207]@Stopyourhavering64
Nice to hear from the other side!
I asked upthread and maybe you can help... I was saying there must be a vast amount of data input needed. Obviously I am pleased you have something to do which you can do from home but what is the reason for the mountains the paperwork and why can this not all be inputted electronically in the first place? Is it just lack of hardware? And presumably it slows down all the results. Not a criticism just would like to understand[/quote]
It's an electronic database which is centrally monitored by the trial RAVE database, used by many different companies around the world for input of trial data) ....so all centres input their data directly on to this database which is stored securely ...so in fact data is monitored in real time and any errors picked up immediately so that we can amend/update the electronic case report file...a very efficient way of data capture
I have to input that correct protocol has been followed and then enter data like previous medical history, conmeds, observations ( BP, Temp etc) ....my colleagues on the ground physically do not have time to enter this data electronically as there time is taken up collecting this data for source documents ie taking your BP etc and administering the vaccine ....there are 18 pages of data to upload for 1 visit per patient !.....then this process will be repeated for subsequent visits as well as noting any adverse events ( side effects) which trial participants make note of in their diaries/app
All this data has to be available in source documents ( ie patients's notes) so that if /when trial is monitored it can be shown that we are adhering to Good Clinical practice (GCP) which is how all clinical trials are run and monitored and if an inspection was carried out by MHRA it could be shown that trial was being carried out safely and correctly !
There are trial monitors working on this trial 24/7 around the U.K./ world where this trial is being run....it's a massive undertaking and I'm so glad to be a tiny cog in a huge wheel as obviously I'm hoping that this vaccine ( or in fact any of the current vaccines) will allow me to get back to clinical work....
There's so much work that goes on behind the scenes of running trials but one good thing that has come out of all this is that it has shown that it is possible to shorten the time take to open trials ( from proof of concept, ethics application/approval to administration of medication) so the hope is that future medical trials will benefit from this streamlining of process which used to take months
I've been working from home since first lockdown in March and was shielding until August and workplace risk assessment still puts me at high risk due to my underlying illness and medication , so still can't work in hospital . However I'm desperate to get back to 'a new' normal, as my 'main' job is running oncology trials which have unfortunately taken a back seat during the pandemic and I miss my colleagues and patients

I have a question just generally... with so many people having asymptomatic presentations of COVID it could be possible for someone on the trial to have contracted COVID and never tested +ve for it. They would presumably then have antibodies present at one of the later visits - would they then 'count' towards the numbers of people contracting COVID in the control group, as obviously there are milestones in terms of number of cases reached to be able to report on results. Has anyone asked this?

@andadietcoke I don't know if there would be a difference between the antibodies from the vaccine and the antibodies from contracting covid . There is also the question marks of false positives with covid testing. Many people saying that this explains the numbers who apparently are symptomless.

Im part of a pro- vaccine fb group. This woman in the group. ( not sure if UK or US) said that she had had her antibodies checked before the study and they were negative.
She wasnt in our trial, she had her 2 injections and then a certain amount of time later she got antibody tests and they were positive.
I'm not sure how i feel. I mean it is tempting to know. However does it hurt the study if participants are doing this.

Thanks for this thread OP.

I had my first jab today and I asked to use the desktop version of the app. They said yes but they forgot to give me the web address. I have my activation code. Does anyone know the web address for the desktop version? Or can anyone tell me what the app is called? If I know that I can probably google it and find the desktop version. Thank you!

It's called Patient Cloud.

I had my 2nd injection yesterday. Didn't have any effects from the 1st jab but have had a very sore arm and achy legs all day this time. Starting to think I might have had the actual vaccine now!

I see a few people have put which trial they are on - it's really interesting to see where you all are! I'm Norfolk and Norwich.

I'm Lancashire so I get a day trip to Chorley :)

@Torvean32

Im part of a pro- vaccine fb group. This woman in the group. ( not sure if UK or US) said that she had had her antibodies checked before the study and they were negative. She wasnt in our trial, she had her 2 injections and then a certain amount of time later she got antibody tests and they were positive. I'm not sure how i feel. I mean it is tempting to know. However does it hurt the study if participants are doing this.

I worked as part of a research team in April that developed an antibody test. We are repeat tested so I know that in September I didn't have antibodies and I will know after the next wave of testing if I do or not now. However, at that stage it doesn't affect the integrity of the study if I unblind myself. I would have asked not to receive the results between dose 1 and dose 2 in case it affected any reporting of side effects but we're past that stage now.

@Anatomical

It's called Patient Cloud.

I had my 2nd injection yesterday. Didn't have any effects from the 1st jab but have had a very sore arm and achy legs all day this time. Starting to think I might have had the actual vaccine now!

Thank you!

It sounds like you might have had the real thing. Fingers crossed.

Interesting thread. I had my first appointment at Cheadle last Wednesday. I'm pretty much convinced I had the placebo. Although my arm still aches 8 days later, I had zero other symptoms, whereas I had the flu vaccine in October and felt rough for days

@andadietcoke

I have a question just generally... with so many people having asymptomatic presentations of COVID it could be possible for someone on the trial to have contracted COVID and never tested +ve for it. They would presumably then have antibodies present at one of the later visits - would they then 'count' towards the numbers of people contracting COVID in the control group, as obviously there are milestones in terms of number of cases reached to be able to report on results. Has anyone asked this?

At the first visit before the vaccine/placebo is injected, blood is taken to look for antibodies.