Yahoo Finance’s Alexis Christoforous, Brian Sozzi, and Anjalee Khemlani discuss hVIVO’s human challenge trial launch for COVID-19, in a Yahoo Finance exclusive interview with Dr. Andrew Catchpole, hVIVO Chief Scientific Officer.
BRIAN SOZZI: Some very important news out this morning on the COVID-19 front. The world's first human challenge trial for COVID-19 will launch in the UK in 2021. This means that healthy volunteers will deliberately be infected with the virus in order to study condition and vaccine treatments. In a Yahoo Finance exclusive interview, I'd like to bring Dr. Andrew Catchpole, he's the Chief Scientific Officer of HVIVO, the company that's spearheading this trial. Yahoo Finance, health care reporter, Anjalee Khemlani, also joins us as well. Dr. Catchpole, good to see you this morning. Take us through this. What's the strategy behind the trial?
ANDREW CATCHPOLE: Good morning. So the ultimate strategy is to set up the challenge models to be able to test vaccines. But the first trial that we need to do is purely to understand what is the lowest amount of virus that we can safely use to establish an infection in the volunteers. So this first trial will have no vaccine involved at all. It's just about establishing the lowest amount of virus. And then we move on to vaccine testing after that point.
ANJALEE KHEMLANI: Doctor, Anjalee here. Thanks for joining. When we're talking about the way that this type of trial is done, I know that your company has done challenge trials before, but this is a little bit unprecedented, because there is no proven sort of very effective treatments against COVID just yet, and that is I think, some of where the controversy of these types of trials is coming from. So can you explain what the, where the confidence is coming and sort of what treatment you're relying on for this?
ANDREW CATCHPOLE: That's right. So this is being done with a lot of care and a lot of caution, so a lot of planning has gone into this. And indeed, not just HVIVO, but world experts across have been inputting into the study design for this. So really, there's three main factors that we're doing to minimize risks on this trial. Firstly, we'll only be enrolling participants into this study that have no known risk factors for more severe disease. So for example, only the very young, 18 to 30-year-olds will be enrolled in this trial. And equally, they would need to be in very good health.
Secondly, we're working with a very controlled amount of virus. So we'll be looking at using very low doses of the virus and very known low controlled amounts of the virus. And thirdly, we're also going to be administering antivirals extremely early on. So as soon as we've detected that these subjects are infected, then they will be administered with an antiviral. So this is very much earlier than you would expect to happen in normal clinical trials or a normal setting where you might need it in hospital. And it's very well known that the earlier you could administer an antiviral, the much more effective it can be.
ANJALEE KHEMLANI: So looking at this, you're infecting healthy individuals. And one of the really key issues here in the US now is the diversity of clinical trials. And so we've talked about diversifying existing vaccine trials to ensure that a broad range of the population is tested in order to ensure that the vaccine works in this broad population. If you're only infecting young healthy individuals, how does that then translate when you do get to the point of vaccine trials, into the broader market?
ANDREW CATCHPOLE: So challenge studies are never use in isolation. So they're used to initially establish whether a vaccine has efficacy, whether it has the potential to then be used and rolled out further. So if we start with a vaccine being tested in this very healthy, safe young individuals, if it isn't effective in them and it's equally important to stop a vaccine in its progress, so that those vaccines which are able to be used and are efficacious, are the ones which are then prioritized for the more field trial testing where at risk, wide diversity populations can be vaccinated.
ALEXIS CHRISTOFOROUS: Doctor, are you able to get the volunteers that you need in the volume that you need them? I'm wondering how this may stack up against other trials that you've done in the past. And are you finding willing participants, young healthy folks who are willing to do this?
ANDREW CATCHPOLE: You know, we're really all seeing a lot of interest in volunteers for this trial, which is really reassuring. Just as at HVIVO, we're keen to do our bit for the pandemic and using our vast experience during challenge studies, we're seeing the volunteers are the same. They just want to do their part to help the pandemic. So yes, we are seeing a lot of interest from volunteers to participate in this study.
ANJALEE KHEMLANI: Looking forward, I know that the UK is just one stop on the journey. There is also discussion about Australia and possibly elsewhere. Can you fill us in?
ANDREW CATCHPOLE: Absolutely. So this very first study will be conducted exclusively in the UK. And once we've completed that study and then determine what is the safe dose of virus, of course, we'll be able to move on to vaccine studies. And then it becomes a matter of how many beds do you have available equals the speed you can conduct these vaccine studies. So we certainly do anticipate that we'll be able to partner with other sites in the UK, as well as globally, perhaps the US, perhaps Australia, to be on a fast track moving forward with vaccine studies. But those plans are very much in the planning stages at the moment.
BRIAN SOZZI: Doctor, what are some of the risks to these volunteers? Do they have, would they have the same condition as people getting infected with COVID on the outside world?
ANDREW CATCHPOLE: So because we're using very low doses of virus, and also in healthy subjects, which are on the younger age demographic, actually what we're expecting to see is the majority of these subjects probably won't even have any clinical symptoms at all. So it's quite possible that there'll be no symptoms or very minimal symptoms. And that's actually not dissimilar to this demographic in the community where there's a lot of asymptomatic infections in this age group.