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Have you agreed to be approached to take part in Covid vaccine trials?

Discussion in 'off topic' started by TheDecameron, Oct 1, 2020.

?

If you’ve put your name forward, have you agreed to participate in a trial yet?

  1. Yes

    5 vote(s)
    45.5%
  2. No

    6 vote(s)
    54.5%
  3. I’m already enrolled in a vaccine trial

    0 vote(s)
    0.0%
Multiple votes are allowed.
  1. TheDecameron

    TheDecameron Unicorns fart glitter.

    I put my name in the hat via NHS trial recruitment and today I agreed to be screened for entry into a vaccine trial.
    It’s a randomised placebo controlled double blind trial. After randomisation you can go into a further sub group where seasonal flu vaccine is given or not.
    I have a number of questions before I agree to entering which you too might want to consider-

    Am I able to receive the NHS vaccine when it’s available even if I’ve had the experimental vaccine? ( I can leave the trial at any time).
    Can I go ahead and receive the NHS flu vaccine if I’ve been entered into the no flu vaccine sub-group?
    Do I want to receive inactive placebo when there’s another trial that might give all entrants active vaccine?
    Do I want to forgo my regular flu vaccination to take part?
     
  2. sean99

    sean99 pfm Member

    I don't really understand your poll. I've volunteered for a trial, but not yet been called upon. I think they already have too many volunteers with my background (white and unlikely to catch COVID). Still, it seemed like the right thing to do (never having been asked to go to do anything particularly risky on behalf of society).
     
    George J likes this.
  3. TheDecameron

    TheDecameron Unicorns fart glitter.

    The NHS advertised asking for trial volunteers and provided a link to register. I filled out a brief online form some weeks ago and got an automated replay saying I might be contacted by a trial.
    Link-
    https://www.nhs.uk/conditions/coronavirus-covid-19/research/coronavirus-vaccine-research/

    Today a trial contacted me by email saying as I’d expressed interest in participating in vaccine trials, would I complete open online eligibility questionnaire which I did. I was informed I was eligible and told I would be approached by my nearest trial site for screening. So I ticked yes above- I’ve been approached and agreed to participate ( in being screenened first).
    It’s the Novavax trial being run through NHS hospitals.
     
    Last edited: Oct 2, 2020
  4. gintonic

    gintonic 50 shades of grey pussy cats

    why?

    I have had a flu vax and volunteered for every trial I could. Not been approached yet.
     
  5. TheDecameron

    TheDecameron Unicorns fart glitter.

    Got phoned today out of the blue by research nurse at local Novavax NHS trial site who was keen to crack on with a phone assessment, with a view to being started next week- blood test for antibodies, swab then randomised double blind to placebo or vaccine. Instantly excluded when I said I was allergic to one foodstuff and one type of drug with no history of allergy to vaccination. I suspect they’ve got a huge number of volunteers and are doing everything to exclude protocol violations and drop outs but I see this as the exercise of very strict exclusion criteria.
     
  6. gintonic

    gintonic 50 shades of grey pussy cats

    Had my ethics committee approved the trial, i would say that is exactly how i would have expected them to behave.
     
  7. hc25036

    hc25036 pfm Member

    This ^^

    The exclusion criteria would have been decide months ago and strictly reviewed by, and agreed with, the MHRA and at least one Ethics Committee. The only reasons for any exclusion are patient safety and absolutely not screening for patients more likely to give a good result. A history of any kind of allergy (ie an abnormal response by the immune system) is a deinite risk factor for an injection that is designed purely to evoke a reaction by the immune system and which has not yet been proven not to misbehave.
     
    gintonic likes this.
  8. TheDecameron

    TheDecameron Unicorns fart glitter.

    I’ll need to stop getting my annual flu vaccine then
     
  9. JensenHealey

    JensenHealey pfm Member

    That is a strange conclusion. Talk to your doctor rather than a forum.

    Contra-indications for the normal flu vaccine are extremely few - which is why it is handed out so commonly.

    A new vaccine under development? - you had better hope that the developers will be exercising extreme caution!

    Related news - I have had a home anti-body test delivered today. Will be doing it as soon as practical - a quick read of the instructions - it seems very easy.
     
  10. Nick_G

    Nick_G pfm Member

    I'll have to investigate as I would in theory be up for this.

    After having vague symptoms which were a bit suspicious in March I did have an antibody test done in July which came back negative. It may have been a case of the flu kept at bay by my annual flu jab, but with the latest results on antibody efficiency it's still possible I had a very mild case of COVID-19 and then antibodies had dropped below detectable levels 4 months later.

    So any chance of a vaccine would be good as far as I'm concerned.
     
  11. TheDecameron

    TheDecameron Unicorns fart glitter.

    To be fair to the research nurse, I’ve subsequently read the Novavax trial registration file and section 7 of exclusions includes “allergic conditions”. You almost never see this in flu vaccine trials which limit the exclusion to known prior hypersensitivity to any constituent of the vaccine or allergy to eggs.
    Of course I’ll keep getting vaccinated because I’m able to respond (when asked) that I’ve never had an allergic reaction to any vaccine.
     
  12. hc25036

    hc25036 pfm Member

    As I had to keep reminding the medics who did trials for me - there's a world of difference between a trial and normal practice. By the time a drug is approved, the risk of being injected will have been shown to be outweighed by the expected benefits of the protection it offers, for instance, people with a history of allergy. During a trial, that calulation will not have been done, so an abundance of caution is required.

    Before anyone asks if those patients are excluded, how will 'they' know, the answer is that there will be a separate, smaller study specifically in patients with a history of allergy which will be carried out very carefully indeed. No point in starting that study before the larger one is well under way.
     
    gintonic likes this.
  13. gintonic

    gintonic 50 shades of grey pussy cats

    I was specifically asked (this year) about allergies to diary and chicken, in addition to eggs.
     
  14. gintonic

    gintonic 50 shades of grey pussy cats

    indeed, often going through the REC and then their parent institution ethics committee. I sat on a REC for a period of time, as a layperson, and it was very interesting.

    https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/
     
  15. TheDecameron

    TheDecameron Unicorns fart glitter.

    Allergy disease is the most prevalent chronic disease in Europe, 20% of the U.K. population is estimated to have it! I’m unclear how a large scale efficacy trial enrolling 30,000 subjects can exclude that proportion of the general population and claim efficacy in such a large sub-population. Why weren’t they enrolling these patients in their phase 2 safety trial? I assume it’s ‘warp speed’?
     
  16. hc25036

    hc25036 pfm Member

    It is normal to do separate studies in ‘at risk’ groups. It would not be cost effective or ethical to include ‘at risk’ patients in a huge study. All patients in a single study have to be treated and assessed in the same way and ‘at risk’ would need extra monitoring (maybe more blood samples) that wouldn’t be justified in ‘routine’ patients. That is extra cost and extra risk to the routine patients. Also, bear in mind that one study has one defined outcome that is assessed statistically. Thus your huge study is designed to assess the outcome of ‘protects against infection’. It cannot, ever, assess a second outcome of ‘also doesn’t unacceptably damage at risk patients’.

    What happens then is a separate smaller study that is designed only for at risk patients which can have smaller numbers and closer monitoring.

    As an example, I designed the developmental process for an agent that is given in huge doses to, literally, billions of people. The agents are really pretty benign (fortunately), but can cause potentially serious complications in a tiny percentage of patients, especially those with serious kidney problems. So we had a few studies of a few thousand patients which excluded patients with kidney problems. Once those studies showed the drug was acceptably safe and effective, we started a couple of much smaller studies which only had patients with severe kidney problems. Those patients were hospitalised for the study and were monitored very closely, including many more blood samples than would be ok in routine patients. The cost was almost as much as one of the much larger studies, but the results were available in time not to delay the approval process.

    If the results showed unacceptable further kidney damage in those patients, then the drug would have been launched to be used only in patients with sound kidneys.
     
    TheDecameron likes this.

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