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When will this shit end?


Chrisp1986

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1 minute ago, priest17 said:

Sad news about Q magazine biting the dust, I used to read it when I worked on Tesco and dreamed of growing old enough to actually appreciate it. Some great writers though, hopefully this just improves journalism elsewhere

ah no! That's the only magazine left that I buy, and is (was, anyway) my plane or train magazine of choice..... 

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2 minutes ago, Ryan1984 said:

I don’t want to put the dampeners on but should we be worried about the word ‘appears’?

What does this mean going forward? Larger trials and then it gets distributed? Anyone have a rough idea of timelines?

Yeah they’re reporting a larger sample to be done.  Tested on just over 1000 so far 

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1 minute ago, sisco said:

Yeah they’re reporting a larger sample to be done.  Tested on just over 1000 so far 

The good news is that these larger trials are already underway in Brazil and South Africa (testing 10,000 people), as I believe the prevalence of virus in the community was too low in the UK, so they are testing it in countries where it is more prevalent to increase the chances of those who are part of the trial being exposed to the virus.

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1 minute ago, Ryan1984 said:

I don’t want to put the dampeners on but should we be worried about the word ‘appears’?

What does this mean going forward? Larger trials and then it gets distributed? Anyone have a rough idea of timelines?

Hi Ryan, "appears" is used as this is the phase1/2 trial, still have to see the phase 3 data to firm things up a bit more...obvious side effects are picked up at this stage, but some rare ones can be missed since the number of participants is relatively small (there were 1077 participants in this study though, so that's a good sized phase 2). The side effects observed were all pretty standard, were predominantly mild to moderate in nature and were mostly managed with paracetamol for 24 hours (without paracetamol, there were a few patients who experienced more severe headache, malaise and fatigue...certainly higher than the control group, though none required hospitalisation as far as I can see and all were self-resolving...side effects at the second dose were much milder than first dose). We'll have to see whether rare side effects are picked up in the bigger trial that is currently underway...only monitoring long term will pick up side effects that develop later on, so this will form part of the regulatory approval (I'd expect emergency use designation rather than full approval, but maybe not). On the plus side, the backbone of this vaccine has been in humans for nearly 2 years with no known longer term side effects, so it bodes well (and other vaccines using this vector produced similar side effect profiles but are considered safe).

The other interesting part of the study was that the antibody response was dose dependent, so a second boost 4 weeks later led to almost all individuals developing a strong neutralising antibody response (suggesting it could be protective). They looked at the neutralising activity out to 42 days and it persisted in individuals that got the booster (and was just as strong at day 42 as it was the week before...placing it around the median neturalising antibody activity of antibodies from convalescent plasma). The other interesting thing is that some of the participants had neutralising antibodies on the day of vaccination, suggesting they probably had an asymptomatic infection prior to receiving the vaccine. Vaccination boosted their antibody response, which tentatively could mean that it might help to prolong immunity where it might naturally wane. Another interesting finding is that the levels of neutralising antibodies detected were in excess of those observed in pre-clinical studies looking at whether reinfection can occur, again, suggesting possible protective effects. All very promising really, needs the phase 3 to go well and also needs more at risk individuals to be tested (since those recruited to this study were aged between 18-55)

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11 minutes ago, JoeyT said:

@Toilet Duck your well written, easy to digest posts are absolutely brilliant.

I genuinely find more useful information in regards to covid on this forum than I do anywhere else.

Thank you.

 

Thank you once more Toilet Duck!

Can you please advise when the results are likely to be published for the older/younger trial - is this Phase II(b)? - mentioned here -

https://www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials

and how long do Phase III trials usually take and results to be published - I think they started on the 20th June

 

 

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Just now, crazyfool1 said:

Thanks @Toilet Duck detailed and helpful as ever ... so is it at the next stage that people outside that age bracket are tried ? and what about people that are vulnerable due to health conditions ? presumably a certain number with each condition need to be tried ... or is that not how it works ? 

Howdy,

Yes, they are recruiting older individuals for the bigger trial (as well as younger ones too). I just had a quick look at the ongoing trials with the vaccine and they are recruiting lots of different types of individuals (e.g., in South Africa, they are recruiting patients with HIV). Exclusion criteria include those with a history of cancer, asthma, prior anaphylactic reactions to vaccines, chronic cardiovascular disease, and any other immunosuppressive condition other than HIV infection (among many others)....so lots of at risk individuals not eligible at the moment. Only the phase 2 trials are listed at the moment, so while the phase 3 is planned, it's not currently recruiting (or if it is, it isn't on clinicaltrials.gov yet!). 

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9 minutes ago, onthebeach said:

Thank you once more Toilet Duck!

Can you please advise when the results are likely to be published for the older/younger trial - is this Phase II(b)? - mentioned here -

https://www.ox.ac.uk/news/2020-05-22-oxford-covid-19-vaccine-begin-phase-iiiii-human-trials

and how long do Phase III trials usually take and results to be published - I think they started on the 20th June

 

 

No worries!

The big question in the phase 3 trial is efficacy, which is why they need to run it somewhere where there is a lot of virus spreading at the moment. The trials to date have been looking at safety (what are the common side effects) and also does the vaccine induce an immune response. If so, at what dose and do you need repeated doses (looks like booster is better). They have answered these questions so far and it looks good...the actual real world data on whether it protects from infection, or if it doesn't then does it protect from severe disease, will become clearer at the next step (preliminary data suggested the second one at least, phase 2 data suggests the first might be possible). It's a massive logistical undertaking to run an large phase 3 vaccine trial, with 10s of thousands of participants spread across different countries, but the team from the Jenner and their partners are ploughing ahead full steam! In places where the virus is rampant, they may well start to see a signal in terms of efficacy in a few months, you basically need enough events to occur for it to be statistically significant (unless it's a home run and absolutely nobody in the vaccinated group gets infected and loads of people quickly get infected in the control group...I wouldn't really expect that, but you never know!). In follow up, they may also see an efficacy signal in their completed phase 2 data since they had a reasonable number of volunteers...most of them live in the UK though where prevalence of the virus has dropped significantly. 

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3 minutes ago, zahidf said:

Interestingly, the Chinese vaccine they are forcing their military to take also had very positive phase 2 results

According to this it’s at ‘Approved stage’ for limited use??

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

Does anyone know what happened to this? It was a big thing about a month ago - has it been quietly dropped due to what appears to be disagreements between scientists/politicians? What level are we currently?

 

 

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