novavax vaccine trial - anyone else?

[Frazzled2207]

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

My app hasn't kicked in yet - it's 7 days after the first injection that it starts so I guess tomorrow.

There is a subset of the trial where they give you the flu vaccine plus the placebo / active vaccine, but nothing was mentioned about this at the weekend. I understand there are no contraindications to having 2x flu jab as long as they're well spaced, and I was given the same advice re 7 days before / 7 days after the second one.

@Torvean32

That’s interesting at mine I was the youngest there (am 42) and lots of the other definitely did have some preexisting conditions and their chat with doc took ages. I was told that right now they are not taking the 65+ age group though there is space in the trial for them at some point too.

@Torvean32 is yours the same trial? Just thought with you saying about a 2w gap between injections (mine is 3) and it being via a clinic - mine is NHS run.

@Frazzled2207 Lots of underlying health conditions with me too (Stepping Hill), including me. But there was the loveliest couple in their early 80s who were really struggling with the app. I think it's so interesting how different centres are dealing with it slightly differently. I think round us they're struggling to recruit anyone from BAME backgrounds. It was very white on Sunday.

@andadietcoke
Also stepping hill! Yes indeed at my session not a single non-white person. Though one of the nurses told me they was also a trial at Bradford and they were more successful there.

[quote Frazzled2207]@andadietcoke
Also stepping hill! Yes indeed at my session not a single non-white person. Though one of the nurses told me they was also a trial at Bradford and they were more successful there.[/quote]
Ahh how exciting! Hope they manage to recruit a more diverse set. More young'uns in my group - one was born in 2000 (I felt so old). I used to go to school discos at Manchester Rugby Club so plenty of unpleasant flashbacks!

A huge thank you to everyone involved in this. What you at doing is wonderful and so important.

@Frazzled2207snap we are the same age. I only saw 3 others in recovery room. Id say the woman was 40s. Then a man id guess 50s and very rude plus a man id have guessed was over 65. Certainly nothing about age in guideline.

I made an error in vaccination times. I saw it is in 3 weeks not 2. Its an NHS trial. Our hospital has multiple building. This one is used for a lot of trials on the door it said clinic for the study.

Yeah i believe there's a sub study with flu jab, but i wonder if its not the same strains as used in the main UK one,?

I was suppossed to start the diary on the app the day after the first vaccination. It sends me a reminder but i cant access it. I can do the daily questionnaire bit about effects from the vaccination.

I think they'll struggle with BAME participants here too. We do have a fairly big Nigerian community. There are smaller communities from areas of India and Pakistan. The city is very majority white Scottish though.
We have a large medical university so i hope there might be students from BAME being involved.

@Frazzled2207 do you have anything to do in the app? I contacted the trial people and they said nothing for 7 days but seems odd that it wouldn't be the same for everyone. Also doubt that it could be based on participant group otherwise it's a very easy way to unblind ourselves!

@Torvean32 I haven't got anything to do in the app. I'm on a thread on twitter and some people have, some haven't. So odd!

Got a call and made an appointment for the study vaccine for late October. They confirmed that I can participate in the trial as long as 1st vaccine is 7 days after a seasonal flu jab.

Can anyone please shed light on the timeline of the clinical trial and the approval?

The document I received tells me not to get any other vaccines during the duration of the trial, which lasts a year (well into autumn next year). Yet, the general expectation/hope is that Covid vaccines will be available to the public as early as early next year or spring/summer. Will the clinical trial cease once they have enough ground to believe it is safe and effective? Does it mean that people given placebo will be informed at that point and be given real vaccine (or at least free to get anything available)? The last thing I want is to be stuck with placebo for a whole year of the clinical trial, whilst the whole nation is being offered with newly developed Covid vaccines.

@Woventabby we were told that if another licensed vaccine is available and we would be eligible for it then one option would be that we withdraw from the trial, unblind ourselves and find out which group we were in. They also said that they were going to ask if the placebo group would be given the licenced Novavax vaccine in the event it was approved. Someone else down thread has been told they will I think.

Thank you @andadietcoke for the information. That has given me a peace of mind!

@andadietcoke i read the reviews on the app on google play. Quite a few ppl that must be on the study are having issues. Some say they cant do the diary or the questionnaires.
Seems like the app is a mess. No idea if it's any different if you have apple via android.
I was called by a tech person all the way from Australia, he couldnt make it work and has regiatered the problem with his senior. I emailed the study so they knew why i did the questionnaire but not the diary.

Why did they call it “nova vax”
Or “No go vaccine”
Bad name.

@Woventabby, sounds like we are all being told slightly different things.
The flu thing is the same. At least 1 week before first vaccine then not til 1 week after the second vaccine.

We had no mention of no access to any other vaccines. Maybe they forgot.

@PlanDeRaccordement
Nova= new

Blame America if you don't like it, its an American vaccine.

[quote Torvean32]@PlanDeRaccordement
Nova= new

Blame America if you don't like it, its an American vaccine.[/quote]
Lol
Because “no va” is Spanish for “no go” and it’s the second language in the US behind English. What were they thinking?

I’m in this trial, went to first appointment yesterday. Did everyone have a pregnancy test? I thought it was extremely odd given that I’m late 50s but they said everyone under 60 in possession of a womb had to have it 🙄🤔.
Re the app, I was told we do nothing with it unless we develop symptoms. If we get symptoms we phone the number on the card and they activate the app, then you start the diary 🤷‍♀️.

Yeah.
Might get renamed if it gets licenced?

Did anyone else see the news clip with vaccines in China. Basically the vaccine isn't licenced however the govt have said if ppl can pay and get to this place they can have it.

@JosephineDeBeauharnais

I’m in this trial, went to first appointment yesterday. Did everyone have a pregnancy test? I thought it was extremely odd given that I’m late 50s but they said everyone under 60 in possession of a womb had to have it 🙄🤔. Re the app, I was told we do nothing with it unless we develop symptoms. If we get symptoms we phone the number on the card and they activate the app, then you start the diary 🤷‍♀️.

Yeah i think legally they have to check. Its a new drug with no idea what it could do to a developing baby. So they have to check. I'm early 40s but it would have been a miracle if i had a positive test.

Seems the app is being used very differently in areas.

@Torvean32, regarding other vaccines, @andadietcoke's information matches what is in Participant Information Sheet, which I have just finished reading.

"If other COVID 19 vaccines do become available in your region, and you may be eligible and recommended to receive them, then the study doctor will consult with the Sponsor and advise you on the options available for you. This may involve your withdrawing from the study, and your being told if you received the study placebo. In this case you could benefit from receiving a newly authorised COVID 19 vaccine available in your region, but this will not be provided to you as part of the study. Rather it will be provided through whatever routine guidelines are in place in your country. "

Thanks @Woventabby that's really useful to know going forward with the study.

I had a really intense physical exam , and I'm thinking the consultant maybe just ran out of time in discussing some things.
It's quite handy getting a medical issue referred by the study when i didn't think anything like that would happen. I'm very grateful.

I'm in this - at the Bradford uni and I'm pretty sure all volunteers I saw where white.
I feel as if I got placebo. No discomfort, no after effects...
Chuffed with the thermometer though as mine had just died!

Day 3 for us now and I've had no side effects other than slight tenderness to touch at the injection site.
DH had a fair old headache this evening but it seemed to pass within an hour or two so probably unrelated. He's logged it anyway.
I think most people in the first trial who had side effects had them after the second dose so I'm trying not to obsess too much about any symptoms, or lack thereof. It really is like the 2ww symptom spotting though