Our next guest is Dr Andrew Catchpole, hVIVO’s Chief Scientific Officer, who joined us in Washington for the Clinical Development and Trials track. Here we learn more about how hVIVO approaches challenge studies, and how beneficial these can be for efficient and effective vaccine development. We are very grateful to Dr Catchpole for his time and insights into the smooth running of these trials. We hope you enjoy the interview!
Introducing Dr Catchpole
As Chief Scientific Officer, Dr Catchpole has “overall responsibility for the scientific conduct” of hVIVO’s studies and laboratory services, and oversees the manufacturing of their challenge viruses. He runs the team that designs the studies and supports their clients with data interpretation.
How hVIVO tackles the task
hVIVO describes itself as an “industry leader” so we asked Dr Catchpole to tell us a bit more about how challenge trials work at the company. He emphasises that challenge trials are “really the main part of our business”. From the “people who are picking up the phones and recruiting volunteers” to the clinical staff, it’s all about “how we can optimise” the studies, create the “best experience for our volunteers”, and provide the “best possible data” to clients.
Having build up a “big body of data”, hVIVO uses this to improve study design, always “challenging ourselves – can we hone this, can we hone that” to give the client the “best possible interpretation” whatever the result.
The volunteer experience
As Dr Catchpole mentions, the volunteer experience is paramount. We asked how hVIVO is able to balance enthusiastic recruitment and participation with stringent safety processes.
“Our first priority, with all challenge studies, is the safety of the volunteer.”
This is in the “absolute fundamentals” of every stage of the operation. Dr Catchpole suggests that “truly informed consent” is central.
“We’re very open about what can happen on a challenge study”.
For example, volunteers need to understand that they will be quarantined!
Patient populations
We were conscious that some discussions at the Congress were centred on the importance of the right patient population for each study. Dr Catchpole suggests that “we always have that in mind”. He emphasises the importance of understanding why clients are using challenges studies in the first place. Typically, the need to establish proof-of-concept necessitates a study in “young, healthy adults”.
“Safety is of absolute vital importance.”
However, when it’s safe to do so, hVIVO tries to adapt the studies to translate into more specific populations. An example is RSV, where the model recruits over 60-year-olds. Likewise, challenge studies can be conducted with asthmatic populations.
“It is possible to go step-wise into patient populations, but you need to build up a really good body of data in the healthy, younger adults first to demonstrate the safety, before you move forward in a progressive manner.”
Pandemic purposes
Our penultimate question was concerned with how challenge studies can contribute to pandemic preparedness. Dr Catchpole believes they can make a “great” contribution.
“In a pandemic, everything’s about speed.”
Thinking about pandemic preparedness with a vaccine in advance, Dr Catchpole explores the difficulty of testing flu vaccines in field trials where the viruses are not circulating.
“In a challenge study, you can build up a body of data specifically targeting a range of viruses.”
At hVIVO, the “world’s first SARS-CoV-2 challenge study” was conducted during the pandemic. Therefore, it “can be done”, but “safety is the absolute first priority”. With a “big enough body of data” you can exclude the most at-risk populations and go forward with less vulnerable groups to test a vaccine.
The Congress in Washington
Our final question, as always, allows us to understand what is bringing our interviewees to the Congress. For Dr Catchpole and his team, the focus is on networking.
“It’s really important networking for us, and really informative to see what’s on the horizon.”
He describes hVIVO’s challenge studies as a “service”.
“They’re only a service to our customers if they’re giving them what they need.”
Therefore, learning about current vaccine and treatment goals, “getting that early knowledge”, is important.
We are so grateful to Dr Catchpole for his time and insight into how hVIVO is leading the field in challenge studies. For more interviews like this, make sure you subscribe to our newsletter here. To get more information about the Congress visit this link to download the post-event report.
