"It might be one of the most important things I ever do in my entire life."

Human volunteers explain why they're ready to get Covid-19 on purpose

Scientists are considering studies that intentionally infect people with coronavirus to speed up vaccine development. Here's why people feel moved to participate.

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A classically trained violinist who watched as the disease spread New York City’s theaters in March. A graduate student in mechanical engineering. A 20-year-old college student who donated a kidney last year.

Most people are trying to avoid from coronavirus, which sickened more than 7 million people and killed over 400,000 people worldwide. These three, and thousands like them, are ready to embrace it.

The violinist, Gloria Lee, is signed up to participate in a human challenge trial for the novel coronavirus. If she is selected, Lee will intentionally be infected with Covid-19 by scientists looking to test a vaccine. The idea to be a part of a trial struck her in May when she realized she might not play another concert until 2021.

“I moved to New York to ‘make it,’” she tells Inverse. Lee is also an adjunct instructor at New York University.

“During the lockdown, it was very odd to go out and see New York completely dead and no bustling, no concerts. The fact that life has stalled so much has allowed me to really think about what I can do to contribute.”

Lee has signed up to be a human challenge trial volunteer through the organization 1 Day Sooner, an advocacy group made up of scientists, and now, 28,280 would-be volunteers from 102 different countries. While the trial she’s signed up for hasn’t even been approved yet, there is a growing amount of support for the idea.

As wild as the idea might seem, numerous scientific papers published since March argue that a human challenge trial is ethically sound. Even the World Health Organization has developed ethics criteria for human challenge studies for coronavirus. In April, 35 members of the House of Representatives sent a letter to the FDA arguing that human challenge trials of coronavirus vaccine candidates should go forward.

Would-be trial volunteers interviewed by Inverse said they were partially motivated by the feeling of helplessness that comes from living during a pandemic. None of them are scientists or epidemiologists, so avenues to help are limited. But as their real lives have disappeared around them, volunteering either gives them a sense of purpose or fills the gaps that were once occupied by normal life.

Gloria Lee playing violin during 2020's coronavirus pandemic.

Abie Rohrig is a rising junior at Swarthmore College. He doesn't know what he wants to major in, but now he's effectively majoring in making a human challenge trial happen. He's working full time with 1 Day Sooner to get such a trial approved. If it goes through, he’s committed to participating.

“I would be willing to take on some small risks to myself if it means that we could end this chapter in history — and all the misery that's going on right now — just a little bit sooner,” he says.

Experimenting on ourselves – SARS-CoV-2, the virus that causes Covid-19, is very new. The idea that we should experiment on ourselves is very old.

Back in the 18th century, British physician Edward Jenner inoculated an 8-year-old boy with material from a cowpox blister. He then repeatedly exposed the boy to smallpox. While the boy never actually developed smallpox, something else emerged: an early, not-exactly-ethical, proof-of-concept for vaccination.

A drawing of Edward Jenner inoculating a child against smallpox.

Wellcome Collection/Wikipedia Commons

Human challenge trials, which also paved the way for Tamiflu, might be old but a question at their cornerstone is timeless: Who would actually volunteer for such a thing?

Part of the answer hinges on the fact that it hasn't always been a volunteer position. “There’s been a whole history — extremely fraught — where minorities were used as experimental subjects without their understanding or consent, oncologist Siddhartha Mukherjee told The New York Times in June.

It hasn't always been a safe position, either. After a previously healthy 21-year-old patient developed a heart condition in a trial, human challenge studies on the flu “came to a halt” in the early 2000s, a 2019 review paper notes.

A resurgence of interestMatthew Memoli, director of the laboratory of infectious diseases clinical studies unit at the National Institute of Allergy and Infectious Diseases, says more people are willing to submit themselves to find a cure.

“I would say in the past 10 to 15 years there has been an increase in acceptance," Memoli tells Inverse.

Now, scientists run human challenge trials that infect people with illnesses ranging from malaria to cholera. Memoli specializes in influenza challenge studies and conducted one of the first since the early 2000s, which he published in 2014. More recent flu challenge studies have happened in hotels converted into long-term research centers — St. Louis University's Salus Center was formerly known as the Watertown Inn.

The general attitude towards human challenge trials “kind of ebbs and flows,” Memoli says. But even if people and scientists are interested in them at the moment, the coronavirus poses unique challenges compared to past human challenge trials.

Abie Rohrig, a volunteer with 1Day Sooner who has volunteered to participate in a human challenge trial for a coronavirus vaccine.

Abie Rohrig

There’s no perfect treatment (though Memoli argues that there’s no “cure” for flu, either). To make things more complicated, we don’t actually know that much about the coronavirus, which causes extreme illness and death in some patients and no symptoms in others.

Finally, there are logistical hurdles to accompany the ethical ones – scientists have to make a virus that actually causes disease in people but doesn’t kill them. That process alone could take as long as two years, by which point we’ll hopefully already have a vaccine.

The scientific and political machinery to create a human challenge trial move slowly. But advocates for them highlight the fact that once set in motion, these trials allow scientists to move fast.

If a Covid-19 vaccine were to enter a large-scale phase III trial, where the vaccine is tested on thousands of people for safety and efficacy, we would likely try to find a population that would end up with coronavirus anyway, says Memoli. As the curve flattens, those people may be hard to find.

"For someone who saves a single life, it's as if they've saved an entire world."

If you did find them, you would still be making a guess about how many people would naturally be exposed to the virus in that population should they never have gotten the vaccine. If your calculations are off or the virus behaves unexpectedly, says Memoli, it might be hard to tell just how much the virus spread through the population and whether it was truly the vaccine that protected people.

In a human challenge trial, you know that everyone has the virus. You can see if the vaccine made a difference and how big that difference actually is. Numerous vaccine candidates can be tested in a few months, says Memoli.

“You determine whether it’s worth moving on to larger trials or if you should just forget about this one,” he says.

Picking the right vaccine and not wasting energy on dead ends has big upsides. Per an article on human challenge trials and Covid-19 published in March in the Journal of Infectious Diseases, "such an approach is not without risks, but every week that vaccine rollout is delayed will be accompanied by many thousands of deaths globally."

Adair Richards, an honorary associate professor at the University of Warwick, affirms that every day we wait means lives will be lost. He published a paper in May on the ethics of human challenge trials in the Journal of Medical Ethics.

The next year and beyond — “The key factor for Covid-19 human challenge trials is the very large number of deaths anticipated to occur in the next 12 to 18 months due both to the direct effects of Covid-19 and the indirect effects such as reduced routine childhood vaccination programs in some parts of the world,” Richards tells Inverse.

For volunteers, the goal is also a speedy vaccine. But participating in the trial also fulfills emotional and spiritual needs. That's the case for Gavriel Kleinwaks, a 23-year-old pursuing her Ph.D. in mechanical engineering. She learned about volunteering for a human challenge trial in March when she came across a Facebook post.

“I’m Jewish and since childhood, Jewish philosophy has been very ingrained in me. For someone who saves a single life, it's as if they've saved an entire world,” Kleinwaks tells Inverse.

But if Kleinwaks does successfully become a part of a human challenge trial, the road to saving lives will not be easy.

Volunteers would undergo initial health screenings and tests to make sure they don’t have Covid-19 or any existing antibodies. Then, each class of volunteers would enter a study facility where they'll have a few days to acclimate before they are dosed with Covid-19 or any test vaccine.

They’ll be there for a month at least. It could be longer depending on how long it takes for them to beat the coronavirus. For some, that could take months, not weeks. Scientists will also have to confirm that people aren't shedding the virus when they're released.

A room in a 24-room research suite that housed volunteers intentionally exposed to flu during a Saint Louis University study.

Ellen Hutti/Saint Louis University

A day in the life of a research volunteer — While in the unit, people can play video games, watch movies, or bring their computers, says Memoli. Participants will eat the food provided to them by staff members. Maybe they’ll get the chance to socialize with other study participants. Not all studies do allow this, but Memoli thinks this would be “reasonable” for a coronavirus challenge study.

In his experience with flu human challenge trials, the hardest thing for people tends to be staying longer than expected, Memoli says. The longest time he ever had to keep someone was 15 days. Once that person got past the 10-day mark, their expected departure time, they started to feel antsy.

“It gets difficult for people to stay away from their friends, their family, their job, their life for that long a period of time," Memoli says. "Anyone who would consider participating in such a trial should really carefully consider if they’re going to be comfortable with that before enrolling."

Kleinwaks says the trial feels so far off that she’s not too worried about spending a month or more in quarantine. That said, “it could be pretty stressful to be under medical observation for a month," she acknowledges.

Lee isn't worried, either, as long as she knows that patients will be taken care of long term. Compensation for trials is an ethical minefield, but she’s hoping that she wouldn’t be missing out on any money she could have gotten teaching should she be selected. In the long run, she'd like to continue to have access to healthcare if she suffered some unforeseen consequence of a vaccine.

“I wouldn't want to go into debt to solve that issue because of the vaccine,” she says.

As for the month of confinement, that doesn’t really sound so different from what we’re all living right now.

“I have thought about the situation, and I would be fine as long as I had my violin and some books. And I know I would be monitored by a well-equipped staff and have access to great healthcare during this time,” Lee says.

Consent is the heart of the human challenge study for scientists, volunteers, and their family members.

The biggest hurdle that Memoli sees towards conducting a trial is that we simply don’t know that much about Covid-19. Some people in high-risk groups develop severe illness and die. Typically, young, healthy people don’t suffer that severely, but it has happened before. That uncertainty makes it hard for volunteers to totally know what they're in for.

“In any challenge trial, no matter what it is, you can never be sure,” says Memoli. “Weird things can happen.”

It’s crucial that patients really understand the risks to conduct an ethical trial, says Richards. The three defining pillars of an ethical human challenge trial are:

  1. Volunteers are told of the risks and benefits in understandable, jargon-free language.
  2. Volunteers have the mental capacity to make these decisions.
  3. Volunteers feel free to stop at any time.

Lee has yet to tell her family, who are mostly based in Korea, about her decision to volunteer. Kleinwaks thought about asking her parents before signing up in March. She slept on the decision, but then decided to ask for forgiveness, not permission.

She didn’t even need forgiveness. When she Skyped her parents and told them the news, they were proud — and worried. During that conversation, she also learned that her dad was preparing to donate plasma.

“I told him I think what I’m doing is safer in a lot of ways, and my dad kind of laughed and said, ‘Yeah, but you’re my kid,'” Kleinwaks recalls.

When Rohrig told his mother about his intent to volunteer for a coronavirus trial, he says she was nervous at first, but unsurprised – he voluntarily donated a kidney last summer. He calmed her by reminding her than he is in a low-risk group (the only ethical population for such a trial, Memoli notes).

The more they talk about it, the more she’s feeling comfortable with his participation, Rohrig says.

She has plenty of time to warm up to the idea. A trial, even if it does happen, could be months or years away. Scientists have time to learn more about the coronavirus. Volunteers have time to sit with their convictions.

“It might be one of the most important things I ever do in my entire life,” says Kleinwaks.

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