What would you do for $3,300? For some people, the answer is getting infected with swine flu.
Most people have forgotten about the swine flu since its outbreak in 2009, but researchers at Duke recently infected 15 participants with the virus. The National Institutes of Health-funded study seeks to create a model of the influenza virus using controlled human studies, monitoring the H1N1 virus to understand how it works.
“It’s a live, but slightly weakened version that is designed to give a certain amount of symptoms,” explained Professor of Medicine Chris Woods, the lead investigator from Duke. “Little bit of a sore throat, some runny nose, some congestion. Very rarely a fever. Occasionally cough. You shouldn’t get any shortness of breath or wheezing.”
This is a “challenge” study—a type of study in which researchers knowingly infect participants—designed to understand how antibodies from previous flu experiences may protect people from getting the flu again. Researchers also hope to measure how antibodies react to the flu and how they are formed or increase in response to the flu. Preliminary results are expected in May 2020.
The study includes about 80 subjects combined at Duke, the University of Maryland, Saint Louis University and Cincinnati Children’s Hospital Medical Center. In exchange, the subjects are compensated up to $3,300. At Duke, each subject stays in the Duke Early Phase Clinical Research Unit for at least 10 days during the study—and longer if the virus persists.
Participants take several urine tests and an electrocardiogram to measure heart activity, and researchers draw their blood at various points throughout the duration of the study.
“This is, for us, a really exciting time. We had been trying to get a strain that was approved for challenge in the United States since the beginning of our program, since 2005 or 2006,” Woods said.
Worth the STINF?
Some Duke students were split on whether the financial windfall would outweigh the inconvenience of swine flu. As mild as the study’s flu strain may be, sophomore Coleman Davis has unpleasant memories of getting either H1N1 or another strain of the flu in 2009.
“I remember fully, it was a very violent illness. There are a lot of pigs in [Swan Quarter, N.C.] I think I got it from one of them,” Davis said. “I used ice packs, oatmeal baths and a lot of Advil.”
His family didn’t take the virus too seriously to stop his sister from dressing up as the swine flu for Halloween. And Davis added that if he’d known about the Duke study, he would’ve considered participating.
“There’s a pretty high chance that I would have. That’s more than I get paid at work,” Davis said.
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But sophomore Ashley Myers said she wouldn’t consider it. She’s too busy, and the compensation isn’t convincing to her.
“Where I am now, as of this moment, I would not participate,” Myers said. “I don’t have a week that I can just go get H1N1.”
When researchers conduct challenge studies, they consider ethical frameworks such as demographics of participants, monetary compensation and consent.
“We’re using a virus which has been studied substantially before. It goes through not only our own ethics review here through our Institutional Review Board, but multiple others across the country including NIH,” Woods said. “But the risks, they’re real. You’re trying to make someone sick.”
Michael McDonald, the founding director for an applied ethics center at the University of British Columbia, emphasized the importance of being up front in consent forms. The form for this study is 22 pages long and is written in easily understandable language.
But McDonald also acknowledged that subjects may breeze through these forms.
“In a way, we [respond like] when we get an update from Microsoft or something from Amazon. We’ll say, ‘Oh yeah, I agree,’” he said.
For Duke students Davis and Myers, if subjects understood the study and gave consent, the research seemed ethical. But Myers had another concern.
“Considering that there’s a monetary gain, potentially people who are out of work would be more apt to participate,” she said.
McDonald explained the problem isn’t only an ethical consideration. A study lacking diversity in demographic groups may lead to skewed results. Plus, it’s important to him not to exploit people who feel compelled to join solely because they need the money.
But he said that for many people, money isn’t the draw.
He’ll hear participants in challenge studies cite family and community members who have had an illness or just interest in being in a research study as motivation for participating.
The next step
Challenge studies beg ethical considerations, but McDonald said they can be the next step toward creating vaccines and preventing viruses.
“[Researchers] did whatever they could in vitro labs, and then they did whatever they could in animal studies where animal studies were relevant. And then the next thing you do is, of course, you try various things to track [viruses] in humans,” he said.
Additionally, it is often impossible to research the virus during a natural outbreak rather than a controlled study. Resources are thin, and there is not enough time to plan a study. And Woods pointed out that researchers often cannot see whose immune systems are fighting off the flu.
Woods said that over the next few years, researchers through the Duke Human Vaccine Institute CIVICs program will work toward creating a universal vaccine for any strain of the flu.
“We are excited to be moving toward this larger program which will include probably several challenge studies over the next many years in order to help evaluate and further develop a universal influenza vaccine,” Woods said.