Many New Yorkers spend their days doing all they can to avoid COVID-19. Some people in New York and across the county, however, are volunteering to willfully expose themselves—and potentially become infected with the virus—through so-called “human challenge trials” in hopes of contributing to the speedy development of a vaccine.
In human challenge trials aimed at a virus, volunteers are either given a vaccine or a placebo. They are then exposed to the virus to test the effectiveness of the vaccine. Right now, a vaccine is predicted to be at least a year away. But these trials can potentially trim that time down to a few months, according to Peter Smith, an epidemiologist who last month co-authored a paper on such trials in The Journal of Infectious Diseases. While unconventional, these kinds of experiments were used in the development of the typhoid, seasonal fly, and malaria vaccines.
Josh Morrison, an advocate for living organ donors in Brooklyn, is organizing volunteers for the trials. Since no tests are starting yet, volunteering through Morrison is like volunteering to volunteer when the time comes. Morrison and the researchers have contacted vaccine manufacturers, and have heard “murmurings of interest,” according to Morrison. Through a website Morrison created a week and a half ago, nearly 1,000 people have signed up already, about 70 percent of them from the United States. Morrison is a volunteer himself.
“Saving just one day of not having this situation would be thousands or tens of thousands of lives saved, and three months would be an amazing achievement,” he said. “In New York, it’s been very depressing and very scary, so I feel like if I could actually do something useful to help fix this and stop this, I would.”
Human challenge trials may be able to accelerate the development of a vaccine because they use a small sample size over a short period of time. According to the authors of the paper, vaccine development typically has three phases, Phase I makes sure the vaccine is not dangerous for humans, Phase II looks at dosages and side effects; and Phase III tests the vaccine on a large sample, usually in the thousands. Typically, in Phase III, participants receive the vaccine or the placebo and return home where they may or may not be exposed to the virus on their own environments. In human challenge trials, volunteers are all exposed to the virus in a controlled area, where results are easier and faster to see. Human challenge trials need fewer participants, as few as 100, and require less time.
“A typical trial takes six months to a year to determine the effectiveness of the vaccine,” Smith wrote. “This is how long it takes for enough cases of naturally acquired disease to have occurred to assess the effectiveness of the vaccine.” In a human challenge trial, researchers do not have to wait for participants to naturally acquire the disease.
Dr. Rajaprabhakaran Rajarethinam, a psychiatric specialist in Michigan, says he volunteered because he wants a vaccine available as quickly as possible, and trials are just a necessary job in that process. “The vaccine is the only thing that can get us back to life,” Rajarethinam said. And, like Morrison, he wants to do his part in fighting COVID-19. “I have a lot of friends who are doctors seeing patients every day. Every single morning they go and do what they can do,” he said. “This is what I can do.”
Megan Herceg, a computational biology Ph.D student in Maryland, does not second guess her decision to volunteer. “The problem is immediate in our everyday lives,” she said. “I’m not too nervous, mostly because of the way that challenge trials work. They are still going to set up the circumstances in which you have a pretty good chance of being helped in the situation. You have to trust people that made it their life to make sure these things are okay for humans.”
Although lethal consequences are possible, scientists reduce the risk to the volunteers as much as they can. According to Nir Eyal, a bioethicist at the Rutgers Institute of Health and co-publisher of the paper in the Journal of Infectious Diseases, those selected to participate in human challenge trials will have a low chance of severe complications. Participants will mostly be between the ages of 20 and 45 and will come from areas like New York City, where they are likely to be exposed to the virus anyway, according to Eyal. If volunteers contract the virus, they will have access to intensive care and medications.
Eyal says that the risk of these trials is worth it, considering the threat COVID already poses. “The low relative risk—that is, the risk as compared to the risk that participants would be facing outside the trial—is what makes human challenge studies a happy marriage of accelerated vaccine testing and ethical treatment of study participants,” he said.
Eyal and his colleagues recognize that there are potential dangerous consequences for volunteers, but they conclude that the benefits the study could have on the world are worth the risks to the small number of volunteers.
As Morrison gathers volunteers, he asks each to write why they want to participate. These are some of their statements, lightly edited and with the names omitted for privacy reasons.
- Over the past few weeks, I’ve found it frustrating that the most valuable thing I can do as a young and healthy person seems to be sitting at home. Participating in a vaccine trial would be a good alternative. When I consider the modest risks of participating in a trial compared to the value of possibly speeding up the release of a vaccine, I feel like the choice would be easy.
- Quarantine sucks, and dying sucks more. So let’s reduce the amount of those things in the world. I’m healthy and young and can very likely survive coronavirus, and I can be more useful as a test subject than sitting on my computer playing dominion all day. It would also reduce the economic impact to low income individuals who have lost their livelihood in this shutdown. In comparison to these huge society-wide factors, the risk of my death is relatively low (though I recognize, not zero). If there isn’t a vaccine, there is a good chance that I will get sick at some point and experience the same odds of death without the benefits of potentially helping people. I feel that this is such a clear and obvious choice for someone healthy and young.
- I just want this to be solved already.
- This image
- I’m an Air Force vet and FEMA certified, but out of the loop because I’m in law school. I want to do what I can to help the effort, and this is a way to help. I’m willing to be informed of the risks and understand them before making a final decision, and interested in learning more.
- Out of college my first job was advocating for investment in developing tuberculosis vaccines, so it’s a cause that’s familiar to me. Also, I’m extremely healthy, so while I recognize that young otherwise-healthy people also develop severe symptoms, I feel like the risk is quite low.
- I want to do something to help in this time of crisis, of course. I’m in a position—no kids, healthy, young (35)—where it’s easier for me to take this risk than many people. I’m a historian. I think what I do is invaluable and vital and so important, but it will never make the kind of impact that doctors do. This feels like something tangible.
- I am a doctor who works in public health research. The prospects of a faster vaccine promise a great humanitarian benefit. As someone who is young, healthy, and with a medical background, I believe I may be a ‘better human subject’ for a study like this due to low baseline risk and being well-positioned to give informed consent.
- I am young (24) and in good health. I care about a lot of people who are not young and in good health. Times like these call for people who are able to be brave and put themselves forward for the greater good of society. I’m optimistic that some developed countries will manage to control the spread of COVID19 in the next few months, but I don’t think global control of the virus will be possible until a large portion of the world’s population acquires immunity either through either infection or vaccination.It’s plausible that the global death toll from the disease will be something on the order of hundreds of thousands per month. Given the possible death toll, I think unprecedented approaches to vaccine testing are warranted. A marginal improvement in how quickly a vaccine is released could be extremely valuable.
- I’m currently not studying in college (though I would like to finish my degree sometime) and am not currently employed. I was in the job search before this all started, but am not thrilled with my chances anymore… As a result of this, I don’t have a lot going on and feel listless and as if I could be doing more to help society out (not in a “I’m useless”/depressive way, but in a “I want to perform a service for humanity but am not sure how” kind of way). I have a deep appreciation for the work that researchers do and I would be thrilled to help them. If I can’t analyze a dataset for a study, I’d be proud to be a guinea pig!
- How often do we get the opportunity to do so much good in our life? I acknowledge there is risk involved; SARS-CoV-2 is a very dangerous virus, but I do think the risk is less than might be perceived at first glance. I live in Brooklyn, so how likely am I to be infected in a counterfactual life and by practicing strict social distancing? I am a healthy 32-year-old and so the risk is less for me than it is for my parents and grandmother. If I were to participate in the trial I would get much better care than I would be able to obtain now at my local hospital.
- I believe in this idea and want to help. I also believe controlled infection is better than random/accidental (easier to avoid passing it on). I’d also would like to gain immunity.
- Human trials make sense in a situation like this. I think my personal risk of dying or becoming permanently impaired would be low, but even if I did die my attitude would be that as a society we should be willing to take such risks in a situation like this. If others do this instead then that’s well and good, but if I participated I’d be happy to have taken part. If monetarily compensated I’d spend the money well, but I’m financially comfortable either way, and don’t assume financial compensation when signing up here
- I would like for a COVID-19 vaccine to be discovered as fast as humanly possible, and this seems like the best way to help. I am still thinking this through, but would love to be contacted if I am a good fit for this.
- I am a third year medical student, which means I am just short of being far enough along in my training to help patients directly. I’m trying to do anything I can do to help.
- I believe I’m a low risk individual – 27 years of age, non-smoker, and in good shape. I studied biological engineering, so I’ve always believed in helping those when we can. If me feeling ill for 2 weeks advances the creation of a vaccine, thereby saving lives, I’m in!
- Philosophers in my tradition (Judaism) teach, “For anyone who saves one life, it is as if they had saved a whole world.” Given the opportunity to participate in a life-saving endeavor, I ought to take it. I’m young and healthy and extremely lucky in many ways, and this is a way to share my good fortune with others.