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Hi FatherTed,
It's a small world....
https://en.wikipedia.org/wiki/Chris_Whitty
..." Chris Whitty, until becoming the UK's Chief Medical Officer, was Professor of Public and International Health at the London School of Hygiene & Tropical Medicine (LSHTM) where he was also Director of the Malaria Centre.
He worked as a physician and researcher into infectious diseases in the UK, Africa and Asia.
In 2008, the Bill and Melinda Gates Foundation awarded the LSHTM £31 million for malaria research in Africa.
At the time, Whitty was the principal investigator for the ACT Consortium, which conducted the research programme..."
Enjoy the rugby !
ATB
Hi FatherTed,
.."And gaining ethical approval for a Covid study might well make future approvals easier to grant too?.."
Rahm Emanuel, borrowing from Churchill : ""You never let a serious crisis go to waste. And what I mean by that it's an opportunity to do things you think you could not do before."
Martin and Meta (Matt less so) at the 1Day Sooner event both made comments to the effect that CHIM UK would give a 'road map going forward' and that, 'whilst we can't - and shouldn't - do things at 'warp speed', the UK will provide a benchmark/pathway'.
So, yes, absolutely .
ATB
Hey Extrader
'hearts and minds campaign'
The more I've been thinking about this - the more I think you are right.
The Covid Challenge Studies are going to put (and have been putting) a global spotlight on Human Challenge Studies . This is the perfect time to push the entire sector forward.
And gaining ethical approval for a Covid study might well make future approvals easier to grant too?
Hi FatherTed,
Thanks for this nuance/link, which prompts a bit of speculation on my part :
Melissa Kapula's description of the challenges (boom boom!) and frustrations in malaria research highlight the value of anything that can contribute to a new approach.
(1) Melissa talks about malaria (a mainly tropical disease, with respiratory side-effects) the time/effort spent in getting a 'standardised' infector...and the problems of finding a 'naive' ie uninfected local supply of research volunteers ie people without NAI Naturally Acquired Immunity;
(2) Andrew talks about typhoid/paratyphoid (now mainly tropical, bacterial) and MrsQuailes, the 'standardised' infector...and mentions that a key issue for regulator was how well the CHIM 'bridged to the population at large'; he mentioned the concern as to how well data /immunogenicity translated from high income to low/middle income countries ;
(3) Chris talks at length about all the precautions and safeguards built into CHIM UK (for the current, global pandemic, with respiratory side-effects) , including use of a GMP GoodManufacturing Process strain of the virus.
The equal airtime given to the 3 makes me wonder if this is part of a wider 'hearts and minds' campaign to encourage a more 'globalist' approach to finding solutions to some of these hitherto intractable diseases.
.."In 2018, there were an estimated 405 000 deaths from malaria globally [ from about 225 million cases, with attendant economic losses] , compared with 416 000 estimated deaths in 2017, and 585 000 in 2010.
Children aged under 5 years are the most vulnerable group affected by malaria. In 2018, they accounted for 67% (272 000) of all malaria deaths worldwide. One in 12 child deaths is attributable to malaria.
The WHO African Region accounted for 94% of all malaria deaths in 2018."
And, circling back, our Dr Chiu is also currently embarking on a Wellcome-sponsored proposed CHIM study in VietNam into dengue, another mosquito-borne disease that ORPH is interested in.
Hmmmmm...
ATB
Hi Extrader and Father Ted thank you both for your in -depth replies ..onwards and upwards..
Hi GG
Just my opinion... but my key take-away is
"Roundtable zoom chat under the auspices of Bill+ Melinda Gates Foundation"
Again, the Gates Foundation pops up (the Foundation's Global Health Investment Fund was set up by Glenn Rockman who currently sits on Codagenix board ). They have a stated aim of eradicating Malaria. Imutex has a Phase 2 ready universal Mosquito saliva based vaccine). I know I keep banging on about this - but it does look as though some rather big ducks might be getting themselves into a row...)
More generally, publicity and discussion like this is great news for the industry. As ORPH is a leader in this industry then great for ORPH too. And it is good to have counter arguments and safety concerns - these move the discussions forward and, quite frankly, I'd be nervous if there weren't proper discussions around this.
The willingness to share is also good news. I can't see anyone wanting to do this without Hvivo/ORPH's expertise (and we do lead the Welcome Trust / hic-vac collaboration).
There will be a lot of people watching the Covid Challenge Studies. If these go smoothly (as they should) then other countries regulators might start green lighting challenge studies. What price the USA?
All in all, the last week or so has been pretty fantastic for ORPH.
Again Extrader - thank you for taking the time to post your notes on this
Hi GGG1111,
.."the relevance to HVIVO is in relation to DIM is this a positive. ?'
Short answer ? I don't know.
Pity there's no edit function here, I meant to add at the end :
.."What is in 'the model', what in 'the protocol' and what in 'the data' would be 'nice to know' info !"
Chiu referred to' IP considerations re the GMP virus', which I'm guessing is CHIMAgents; I'm not clear where /whether data fits in (ie was it just an oversight/not thought relevant in what was a quick 'live chat reply') , which I think is the bit of greatest interest to us from a possible monetisation/wearables perspective.
HTH
DIM has became an additional lottery ticket. I'm eager to see what unfolds. Hopefully a bidding war between the tech giants.
Extrader thank you for your post ..I suppose the relevance to HVIVO is in relation to DIM is this a positive..
Father Ted I would be interested in your opinion on EXT post from yesterday..Cheers
Extrader - thanks for the great notes, much appreciated!
Earache, I would question any direct comparison between flu and covid for the simple reason we have never tested people for flu like covid and also the figures do not show percentage of people hospitalised as a result of flu v covid because they are simply not available.
Continued/....
The Q and A was mostly on the ethics side
Andrew Pollard was asked about doing CHIMS for 'local disease in a local setting'. He said that for a regulator a key question was how well a CHIM bridged to the population at large. He said that if you wanted to protect children in Asia from paratyphoid, it was better to CHIM in the target population.
OTOH, if you were looking to treat 'naive' children in the tropics for malaria, you would be unlikely to find many 'naive' adults locally for your CHIM study. But using readily available 'naive' volunteers in Northern Europe might introduce other ethical issues- immunogenicity was one he mentioned (data not always transferable from high-income to low/middle income countries).
Chris Chiu was asked about risk mitigation steps, he repeated the 'relatively low risk' and various precautions - minimal dosages; clinician involvement; time invested in making sure that consent was 'informed'; time invested in getting ethics committee on side, public consultations, focus groups etc.
Finally - and perhaps most interesting for ORPH investors - he was asked :
" Will you or hVivo own any intellectual property or data relating to the CHIM C-19 study model and how do you plan to share these assets with other entities ?"
Chris replied initially with :
.." Our aim is to share the model and expertise as widely as possible. we will be publishing the protocol and are very open to collaboration. There are IP considerations relating to the GMP virus, contact me if you wish to discuss."
In follow-up, he expanded on this, I understood him to say that
- UK Vaccine Task Force/HMG 'own the data and the GMP virus' and would share;
- hVivo was willing to share with ' safe' (I took this to mean clinically equipped) partners;
- Wellcome Trust also wanted to share the 'model'.
IMO, E and OE
HTH
Hi all,
Roundtable zoom chat under the auspices of Bill+ Melinda Gates Foundation, keynote speaker yesterday Fauci, today Bill himself.
Presentations and Q + A from Melissa Kapula (Kenya, malaria); Andrew Pollard (Oxford, typhoid, lead on UK CHIM); and Chris Chiu (Imperial, immunologist specialist in respiratory, co-lead on UK CHIM).
From Melissa's presentation , I learned of the back-breaking work in finding an effective treatment for malaria : 434 trials since 2000, including 40 CHIMS.....but only a total of 724 volunteers in 10 countries in the last decade. [So the UK CHIM is actually quite a big deal].The challenge is to research solutions suitable for 'naive' populations (people without 'naturally acquired immunity' NAI) , since the disease is mostly a killer of the young. So a lot of time has to be diverted to understanding the effects of NAI and how to 'unpick' its effects from the research results.
Andrew Pollard spoke about his work on CHIMs for typhoid. His narrative highlighted the importance of a standard strain of 'infector' for benchmarking purposes : a Black American Mrs Quailes has been immortalised by Maryland Uni using 'her' virus as the standard for 1950-1970 and still used for several hundred studies over the last decade.
Chris Chiu opened by putting C-19 in context : 100m cases and 2m deaths attributed; this compares with'flu : 5m cases and 250-500k deaths pa; and RSV : 60m cases and 200k deaths pa. RSV is respiratory syncytial virus, eg bronchitis and pneumonia , bad for kids and the elderly.
Traditional research is 'after the event' : you only see the patient when already unwell; they appear randomly (at different stages of disease progression); there may be random environmental 'confounders' and non-standardised dosages/treatments.
CHIMs offers standardised dosage; reproducible infection rate ; homogeneity of subjects/volunteers; and access to them during all the pre-infection/pre-symptomatic stage; and again afterwards, for long-term follow-up.
Through 'head-to-head' at Phase 2, CHIMs will enable quick elimination of less promising candidate vaccines and significantly de-risk Phase 3 candidates.
Factors that weighed in eventual ethics OK for the UK CHIM included a GMP (good manufacturing practice) grade agent; hVivo track record; containment facility (Royal Free); clinical monitoring; and controlled dose escalation.
Why CHIM now, if vaccines are available ?
- vaccines may confer immunity, but asymptomatic transmission is still a risk to others;
- we need to understand effects/effectiveness of new formulations; different/differently timed doses; durability of protection;
-as 'naive' population shrinks, field testing becomes impractical - and a placebo control almost unethical.
This was all good background for the ensuing Q and A.
Continued/.......