Com-COV2 vaccine trial

[RogerS]

This is a limited number trial to test possible interactions/benefits/drawbacks/side-effects etc of using different vaccines between Jabs 1 and 2. I'm on it and had my second jab today. But of what I know not. Could be AZ again Or Moderna. Or Novavax.

So far no side-effects. We have an e-diary to fill in each day and one of the questions is redness or hardness of the injection site. Well...I would if I could see it or knew whereabouts it was. Nothing. Not a red spot. Nowt.

 

[Mike G]

Good for you for doing this, Roger. How did you hear about the trial?

 

[Steve Maskery]

I've signed up for the same trial, but not yet heard whether or not I have been accepted.

 

[RogerS]

Good for you for doing this, Roger. How did you hear about the trial?

I chanced upon it on another non-woodworking forum.

 

[MattS]

Need people to volunteer for trials well done.

I've been wondering when I hear the percentages, how do they test the effectiveness of a vaccine to get the statistics?

 

[RogerS]

Need people to volunteer for trials well done.

I've been wondering when I hear the percentages, how do they test the effectiveness of a vaccine to get the statistics?

I'm not an expert but this is my understanding having taken part in a Phase 3 trial and now this one.

In the Phase 3 trial, Novavax, for example, recruited 45000 trialists IIRC. If we caught Covid then we were supposed to let them know. So at the end of the trial if x % of those who caught Covid had had the placebo then I think they then calculate the stats based on that. of course, it dies beg the question as to just how exposed might some of the trialists have been. I hardly went out and so myexposure was minimal. If everyone was like me then the figures would be very skewed and bear no relationship to real-life. But with 45000 I think the sheer numbers even things out.

But I'm not a statistician !

Regarding the latest Com-COV2 trial, we get our bloods taken and analysed throughout. So they can get a very good understanding as to just how well our immune system is responding. Bloods taken before the jab and thence at intervals. Next one is 28 days time.

They also offer some participants the opportunity to take a slightly more in-depth involvement to see how the t-cells are responding (involves nasal swabs and saliva samples and a couple more visits) but because these samples need processing down in Oxford the same day, Newcastle is too far away !

Arm marginally sore but apart from that OK...I think. Odd little moments of this and that but nothing worth mentioning.

 

[RogerS]

Need people to volunteer for trials well done.
....

The ones that really need the plaudits are those in the Phase 1 trial for that is the largely unknown territory. By the time you get to Phase 3, the risks are pretty well known and so much, much lower.

 

[MattS]

Thanks Roger, confirmed what I thought. It's a big subject group but also a very big unknown about people's exposure to determine effectiveness.

 

[Villa Chemist]

I think the trials are slightly different as I understand it. The large trials judging vaccine effectiveness against the virus are randomised and the results are reviewed after so many (e.g. 100) of the volunteers have tested positive. Someone then unblinds the results and sees how many of the positive cases had the placebo and how many had the vaccine. The more prevalent the virus is in the general population, the quicker 100 people will become infected and the quicker you get the results. That’s why they switched some of the trials to Brazil as the infection rate was higher at the time.

The new mixed vaccine trial is monitoring antibody and T-cell persistence as far as I’m aware.

 

[RogerS]

I think the trials are slightly different as I understand it. The large trials judging vaccine effectiveness against the virus are randomised and the results are reviewed after so many (e.g. 100) of the volunteers have tested positive. Someone then unblinds the results and sees how many of the positive cases had the placebo and how many had the vaccine. The more prevalent the virus is in the general population, the quicker 100 people will become infected and the quicker you get the results. That’s why they switched some of the trials to Brazil as the infection rate was higher at the time..

I don't think so. Our infection rate was pretty high at the time.

The new mixed vaccine trial is monitoring antibody and T-cell persistence as far as I’m aware.

Not for everyone. There is a separate Immunology Cohort (as I mentioned above) who also get involved with the T-cell stuff.

 

[AndyP]

Kudos for doing it Roger and all the other guinea pigs out there that put themselves up for these trials. We felt with kids the way they are that we could not take the risk but I am damn glad that you and others like you did.
Thank you.

 

[Villa Chemist]

I think the trials are slightly different as I understand it. The large trials judging vaccine effectiveness against the virus are randomised and the results are reviewed after so many (e.g. 100) of the volunteers have tested positive. Someone then unblinds the results and sees how many of the positive cases had the placebo and how many had the vaccine. The more prevalent the virus is in the general population, the quicker 100 people will become infected and the quicker you get the results. That’s why they switched some of the trials to Brazil as the infection rate was higher at the time..

I don't think so. Our infection rate was pretty high at the time.

The new mixed vaccine trial is monitoring antibody and T-cell persistence as far as I’m aware.

Not for everyone. There is a separate Immunology Cohort (as I mentioned above) who also get involved with the T-cell stuff.

I heard some discussion at the time the phase 3 trials were being planned that, as the infection rate in UK was falling, they might get quicker results by moving to countries with higher infection rates (like Brazil). Could be wrong though

Yes, they’re separate tests. I had antibody and separate T-cell tests when I was part of a therapeutics study in Oxford when I got the virus in December. That’s when I got my superpowers...that’s what I tell the kids at school anyway.

 

[RogerS]

Wowzer! Got up this morning as usual, didn’t feel hungry though and also very bloated. Just about finished the washing up from last night when I felt myself coming over all weak and thought I’d faint. Scuttled upstairs to bed. Very, very tired. Just want to sleep.

Only typing this as LOML had made an ‘illegal’ sortie to the outside freezer in the workshop and opened the drawer that should never be opened as it’s a right sod to get back in. So had to get up and go sort it!

Back to sleep.

 

[RogerS]

Back to normal apart from no appetite.

Really impressed with the trial team as I delightful young lady doctor called me to discuss my daily e-diary entries that I'd been submitting and check up on me. 10/10