‘People assume you’re crazy for doing it’: Melbourne clinic infecting healthy patients
Ggreen plants, cool tones, casually placed decorative cushions: this living room in East Melbourne could belong to any millennial – or at least rentable. The squeaky hallway floors are a giveaway, though; along with the beds on wheels.
This is not a real estate opportunity, but Doherty Clinical Trials (DCT) – Australia’s first unit dedicated to human challenge studies, where trial participants are given a dose of an infectious disease in a controlled environment. An offshoot of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne, it opens on Monday – an incubator, its owners hope, for discoveries that could redefine the future of disease.
Human challenge studies, or controlled human infection models (Chim studies), are “highly valued as one of the most efficient ways to evaluate the efficacy of new vaccines and therapies,” says Andrew Brockway, CEO of the facility. They serve two main purposes: to provide insight into diseases, such as influenza or malaria, or “to more quickly determine whether and how well a specific vaccine or drug in development works” by administering it to a small cohort, all of whom are subject under the same conditions.
According to Brockway, this could provide more reliable and reproducible results than larger studies, where variables are less controlled, and could help explain which types of immunity influence disease by comparing how different participants respond to the same infection. These types of studies could shave years off the usual 10 years it takes for a vaccine to be approved. Speeding up this process can also have major financial benefits.
Challenge trials, which started more than a century ago and are led by Britain, Australia, Europe and the US, are expensive to run and recruiting healthy volunteers can be difficult.
That has done little to dampen the ambitions of DCT, which plans to move to a larger location in 2027. On the slate in his current home are studies in which participants will become infected with influenza, malaria, streptococcus A and oral gonorrhea. Other trials, carried out in collaboration with academic researchers and biotech companies, will test new technologies including a microneedle patch and a prophylactic nasal spray for Covid – both of which are designed to replace jabs entirely – while a Moderna partnership will look to accelerate the development of new technologies to develop. mRNA vaccines. Brockway hopes that the data collected here “may also contribute to the management of future pandemics.”
Meta Roestenberg, professor of vaccinology and clinical lead of the Controlled Human Infection Center at Leiden University in the Netherlands (not affiliated with the Doherty clinic), says trials with human challenges have provided “very fundamental insights that are extremely useful” when it comes to arrives for research into infectious diseases. She points to the development of Vaxchora, the first cholera shot approved in the US in 2017, and RTS,S, a malaria vaccine now being rolled out in sub-Saharan Africa, as examples of vaccines that are “very clearly show how challenging research can be’. assist in the development of new products”.
But who would sign up? Brockway says the participants are “often young college students.” “We have a lot of backpackers coming through,” he says, likely encouraged by the financial reward, which is set at the minimum wage of $23.23 for every hour spent at the clinic, which can stretch to weeks. fallen. ‘It’s not like we can just say, ‘Hey, are you here for malaria?’ We will give you $2,000 for this visit,” says Brockway. The compensation is a standard hourly rate, not illness-related.
Between observations and blood tests, participants can peruse the neatly kept bookshelf or visit the game room, stream movies or have Zoom calls. The idea is to make it attractive – extra wide beds, nice linens – to encourage participants to come back or tell their friends. As far as short-term rentals go, it’s not too bad.
Some volunteers do it for science. Keller Scholl, a 29-year-old PhD student, signed up for a Zika challenge trial in the US last year after seeing a tweet urging participants: “I want to make the world a better place. This was something I could do and we don’t have enough volunteers,” he says of his decision to sign up. Although he adds that he “couldn’t have done it without the pay,” which amounted to about $7,500 for nine days.
Scholl and three other participants were placed in a hospital. They had a five-bed dorm to themselves and shared book recommendations, ordered food (although one volunteer did “great scrambled eggs”) and watched Netflix. The days passed easily until a rash developed on Scholl’s forehead and upper arms. On day nine on the way home, fatigue started to set in “and the itching became painful and continued to escalate.” It turned out to be “nothing serious,” he says, admitting that he would have preferred to be in the placebo group and given a dose of saline instead of Zika.
Still, he would ‘absolutely’ do it again – a sentiment shared by 22-year-old Jenny McMichael, who recently completed a whooping cough challenge trial in Britain and is now looking for another to take part in . “People assume you’re crazy for doing this,” she says. “(But) I actually really enjoyed it.”
Volunteers are crucial to challenging the future of research, but Roestenberg appreciates that the idea of “intentionally causing symptoms in healthy volunteers, causing people to develop diseases” is very counterintuitive when you think about the ‘first, do no harm’ principle of medicine” – the promise made by all physicians when taking the Hippocratic Oath.
There are other problems at play. Together with the fact that infections with known diseases ‘scare people’ (again, counter-intuitively, even more so than experimental drug trials), they also raise major ethical concerns. I ask Scholl if he felt he fully understood the ethical implications. “I have a minor in philosophy: I have no confidence in the ethical implications of anything,” he says.
Challenge studies require approval by an independent ethics committee that has previous experience in reviewing such studies and are bound by Australian National Health and Medical Research Council guidelines. Subjects must sign a consent form – detailing all benefits and risks and how to request compensation – which is also reviewed by the ethics committee before the start of the study. Medicines Australia is the administrator of the Voluntary Compensation Guidelines, which require trial sponsors to pay compensation to participants in the event of injury.
Brockway says DCT, like all facilities contesting trials, “will operate under the highest standards of scientific, clinical and ethical conduct.”
Patrick Foong, a senior law lecturer specializing in bioethics at Western Sydney University, says “there is a risk-benefit analysis that needs to be justified” for human experimentation. “The human participants in research may not really know what they are getting into.” That there is now so much trial recruitment taking place on social media, apparently promising thousands of dollars in exchange for a few scratches with a needle, “is what we are a little concerned about,” Foong adds. “When people are desperate, they’re not really in the right frame of mind to make an informed decision.”
This issue was brought into sharp focus during the pandemic, when pilot trials for Covid vaccines were launched. Concerns were expressed that “many people would have lost their jobs, leading to financial desperation and the potential attraction of vulnerable participants,” Foong wrote in a co-authored article at the time. “The serious concern is that the money offered to them could act as an inducement/undue influence to participate in the experiment, which could raise further ethical concerns.”
Ultimately, the benefits were deemed to outweigh the risks, and the trials continued (another Covid challenge trial did). announced earlier this month). Contrary to what it looked like at the time, the opening of DCT is a signal, Roestenberg thinks, that there is now a better understanding of the value of human challenge trials.
“I think it makes perfect sense that there are more institutions around the world developing the capacity to actually do these types of studies and ensure that we don’t end up in a capacity problem,” she says. “I’m very happy to see (them) expanding.”