When the Campus Becomes a Lab to Study Covid

A major study will seek to enroll more than 12,000 students at 21 universities in an effort to answer a key question: Does Covid-19 spread after vaccination?

The project, announced Friday, could shed valuable insight on the future trajectory of the pandemic as the pace of vaccination increases. It also marks the latest instance of campuses — often with students as subjects — serving as laboratories to understand the coronavirus.

Other studies, which have examined quarantine duration and how Covid-19 spreads, present risks and rewards for institutions. They can add complexity to the process of trying to track the disease on campus. They can raise questions about the power dynamics of when an institution researches its own students. But they can also shed important light on the virus itself, illustrating how colleges are in some ways ideal locations to study the coronavirus.

The project, with money from the National Institute of Allergy and Infectious Diseases and the federal Covid-19 Response Program, will examine how vaccinated students are infected by and spread Covid-19, relative to a control group of non-vaccinated students. Students will take daily Covid-19 tests and keep a diary for five months, and their close contacts — about 25,500 people — will also have to answer questions and be tested. The first doses of the Moderna vaccine were administered this week.

Larry Corey, the virologist and former director of the Fred Hutchinson Cancer Research Center who is the principal investigator of the Covid-19 Prevention Network’s operations program, is one of the study’s leaders. He said initial clinical trials for vaccines purposefully focused on the extent to which vaccines limited severe infection — it was the most important question to quickly answer. But it is also “really relevant” to know whether the vaccine prevents transmission, which could inform the future necessity of masks and social distancing.

The trial wasn’t easy to set up. It requires thousands of vaccines — every participant will be vaccinated, though half will wait several months — an immense amount of testing, compensation for participants and their contacts, and a complex logistical operation.

In December, a spokeswoman for Niaid told The Wall Street Journal that the agency expected that it would be difficult to enlist university health-care workers to run this study, as they may already be stretched thin with containing Covid-19 on campuses. The outlet reported that the study had stalled.

The current iteration of the study enrolls fewer students, and the atmosphere on many campuses is different now than it was in the fall, when many institutions were challenged to contain the virus, said Myron Cohen, director of the University of North Carolina’s Institute for Global Health and Infectious Diseases and a leader in the Covid-19 Prevention Network.

Doses for this trial come from those set aside for research by the U.S. government, so the study won’t take vaccines from more vulnerable populations, a website promoting the study said.

Assurances and Benefits

Throughout the pandemic, researchers and college leaders have made different choices as they considered studying Covid-19 on campus, and this latest project indicates high confidence in the possible impact of this work. “Your plans are all canceled anyway, might as well sign up and be a part of history,” language on the study’s promotional website reads.

Still, it’s a challenging prospect. Research protocol requires additional work to secure the appropriate approvals — which means that running the campus coronavirus logistics machine is even more complicated. That’s a lot of uncertainty in an already difficult environment.

One major institute that has conducted more than 14 million coronavirus tests in the past 12 months intentionally avoided researching Covid-19 in colleges. More than 125 colleges have relied on the Broad Institute of the Massachusetts Institute of Technology and Harvard University for Covid-19-testing logistics this year. One way the institute encouraged colleges to sign up for the service, said Niall Lennon, senior director of translational genomics, was by assuring them that the institute would not be doing epidemiological research on samples in their tests. This, he said, would allay any potential student concerns about how their results would be used.

“We’ve tried to back off — we’re just providing the data” to operate safely, he said.

But there are benefits to researching widely within higher education. Promotional materials for the multicampus study said college students are “ideal” for this study because they experienced large numbers of infections this year — housing is dense, and many students want to socialize. Many residential campuses are closed populations, and the risk of severe illness after infection is lower for the population of prospective participants, 18 to 26 years old.

There’s also the fact that asymptomatic students on campuses get tested far more than asymptomatic people in the general population. That was a key advantage to research conducted at the University of Colorado at Boulder, which analyzed more than 72,500 saliva samples collected in tests during the fall semester.

“The rest of the world is focused on people who suspect they may have Covid, or have symptoms, or are in the hospital,” said Sara Sawyer, a professor of molecular, cellular, and developmental biology at Boulder and the study’s senior author. “What’s so cool about all the university papers that are coming out is that you have this snapshot of what’s walking around around you when you leave your house. What’s happening when you walk into Walmart.”

The team’s findings, which are still in pre-print status, indicate that viral loads are similar in asymptomatic positives to what has been published about symptomatic positives. A small fraction of positive cases, 2 percent, carried 90 percent of the virions in communities. Such a conclusion would be difficult to make without the massive dataset collected through campus operations.

Useful Results

Other findings from campus-based research have implications for how colleges manage the virus.

Elsewhere at Boulder, Kristen Bjorkman, the campus’s Covid scientific director, used data from the university’s Covid-screening program and contact-tracing efforts to find that transmission of Covid-19 between roommates only happened 20 percent of the time. (The paper is still in pre-print status.)

“Doing the research to understand what happened in the fall was really critical for us to plan for the spring,” she said. For students and parents, “this is actually some reassuring information.”

In the fall, Jill Kolesar, a professor of pharmacy at the University of Kentucky, began researching quarantine times. If isolation was for a shorter duration, would more people adhere to the rules? Her colleagues tried to determine the quarantine day by which any asymptomatic contact of a positive student who ultimately would test positive, had tested positive.

To do this, her group had to add another layer onto the already complicated campus machinery that tried to keep Covid-19 in check.

After the on-campus team that worked on contact tracing reached out to possible contacts of Covid-positive students, members sent the daily list of contacts to Kolesar’s colleagues, she said. The team then called those contacts, asking if they would enroll in the study. The people who said yes would be connected with an outside testing vendor.

The study, available as a pre-print, was a “huge undertaking,” requiring constant communication with administration, the student-health team, and the testing company to “get it organized, keep it moving,” Kolesar said. But the finding was significant: Anyone who tested positive in the 14 days of quarantine had tested positive by Day 7, meaning that the campus could require fewer days in isolation.

Outside Input

The relationship between a student and their college is complicated, encompassing education and sometimes employment, housing, and dining. For the multicampus study announced Friday, a so-called “youth advisory board” comprised of 50 student representatives from participating campuses was created to bring forward campus and community concerns and questions. Members will also brainstorm promotional and educational materials about the research.

Each site has a local institutional-review-board approval process as well, a spokeswoman for the project told The Chronicle. These boards, which examine research processes in an effort to mitigate negative consequences for participants, can be a crucial safeguard as studies are developed.

Sawyer, the Boulder researcher, and her colleagues set up a study in parallel to the campus’s Covid-testing operations. Her finding on asymptomatic viral loads did not need IRB approval, as it was based on observational data from campus testing, she said. But anyone who got tested on campus could sign up for a separate study that involved survey questions — on whether they socialized without masks or took in-person classes, and how they felt about vaccines — and could also opt-in for further analysis of their saliva samples. Such an analysis may include sequencing the virus and understanding variants on campus, and they got IRB approval to proceed, she said.

“Their job is to know every word of every regulation that pertains and to put the bumpers on your bowling alley, so to speak,” Sawyer said.

Bjorkman said she and her colleagues spoke with the IRB about the study about roommates, the idea for which came about because contact tracers at the university were surprised at how few roommates of positive students tested positive. Officials said there was no need for a review-board approval as the data on which the research is based is operational, she said.

Public-health agencies have long been allowed to examine trends as they conduct surveillance on key issues, said Robert Klitzman, the director of the master’s of bioethics program at Columbia University.

Klitzman, the author of the book The Ethics Police?: The Struggle to Make Human Research Safe (Oxford University Press), recommended that researchers proceed carefully and check with institutional-review-board officials before conducting studies based on campus work. Certain descriptions of anonymized data — say, a line that references occupants of the corner room of a dorm — could unintentionally identify subjects.

Having an “outside set of eyes” evaluate the possibility of harm to participants, especially if they are students, would be an important gut check, he said.

“One needs to think out these issues,” he said. “It would raise concerns if a group could be identified in any ways that might be stigmatizing to them.”