Vaccine researchers are trying new tacks in an unprecedented effort to recruit the tens of thousands of healthy volunteers needed to finish testing coronavirus shots in late stages of development.
Quickly lining up all the subjects for so many studies at the same time poses several challenges, creating competition among companies.
Given the urgency, researchers are taking unusual steps, such as recruiting at pharmacies, enlisting churches in searches for subjects and even requesting employees and families to ask around.
Researchers are also rolling out algorithms to target recruitment in places at risk of getting hit with the virus.
Finding the patients will be crucial to conducting the trials to evaluate whether the experimental vaccines safely protect against the virus. The broader population can’t start getting vaccines until the shots pass muster in the trials.
The trials must enroll enough patients, in enough different parts of the U.S. and overseas, so that sufficient numbers are exposed to the virus to enable researchers to measure whether it works.
So many vaccines are nearing the pivotal testing phase that researchers and companies feel they must go to extraordinary lengths to recruit all the subjects needed.
“We not only have to find the number of volunteers, but they need to be in an area where the virus is currently spreading, otherwise you learn nothing about the effectiveness of the vaccine,” National Institutes of Health Director Francis Collins said in an interview.
“It is a big task, and it means pulling together all of the clinical trial capacity that we can,” he added.
Health authorities and scientists view vaccines as the best way to stop the spread of the new coronavirus. Dozens are in development to increase the odds that some will prove to work and then can be supplied as broadly and rapidly as possible.
Several coronavirus vaccine candidates have shown promise in small, early studies, but they still must be tested on thousands more patients before regulators allow them to be widely available.
Normally, drugmakers recruit patients to test potential products through advertising, on social media or when patients visit doctors. Trials can take years from start to finish, and vaccines on average take more than a decade to develop. But the luxury of time has all but disappeared with Covid-19.
“It really is a major project beyond the scope of anything I’ve done before,” said Mark Mulligan, director of the Vaccine Center at NYU Langone Health, which will be involved in late-stage trials and is devoting extra clinics for the testing.
Several of the final-stage, or phase 3, trials are expected to begin in coming weeks, after what researchers and industry officials describe as a remarkably fast time line for designing the vaccines and studying their safety, dosing and signs of effectiveness in earlier phases.
The U.S. federal government is planning to fund three 30,000-person trials starting this summer: Moderna Inc.’s vaccine starting this month, followed in August by a vaccine co-developed by University of Oxford and AstraZeneca PLC, and in September, a vaccine developed by Johnson & Johnson . Oxford’s vaccine recently began late-stage testing outside the U.S.
Pfizer Inc. and partner BioNTech SE plan to start their own 30,000-person trial of their vaccine this month, too.
Researchers have planned to enroll more subjects than are typical in vaccine trials to ensure enough people are exposed to the virus so they can determine quickly if the vaccines work safely, Dr. Mulligan said.
The scale is so large it means trials are effectively competing with each other for recruits.
“One volunteer cannot be in two different studies. It’s a zero-sum game in that regard,” said Dr. Joseph Kim, chief executive of Inovio Pharmaceuticals Inc., which last week announced positive results in a small study and is preparing for a larger study.
PRA Health Sciences Inc., which helps recruit trial patients, is mining busy Covid-19 testing locations, including public-health departments, testing labs and pharmacies, to find healthy volunteers, said Kent Thoelke, PRA’s chief scientific officer.
Cincinnati Children’s Hospital Medical Center, which is preparing to test the Oxford shot, is contacting participants from non-Covid trials, emailing the hospital’s 16,000 employees, urging them reach out to friends and families, and following up with 7,000 people who contacted the hospital after it was identified as a site for Pfizer’s early-stage vaccine study, said Robert Frenck, professor of pediatrics at the hospital.
“We’re kind of pulling out all the stops,” he said. “I want to make it so that if people want to have the opportunity to participate, they can.”
Complicating the recruitment efforts, industry officials say, is making sure not only that the trials reach a set number of subjects, but also that they include sufficient numbers of elderly, ethnic-minority and other participants at higher risk of infection. Public-health officials have said representing high-risk groups is important, and regulators have encouraged their inclusion.
Dr. Frenck said he is also meeting with community groups and churches to ensure trials include high-risk populations. The hospital plans to dispatch mobile physician offices to retirement communities.
Speed is a concern. The trials can’t finish until enough vaccinated volunteers become exposed to the virus in everyday living. To meet that goal quickly, researchers are trying to identify areas at risk of spreading virus and recruit there, said Kathleen Neuzil, professor of vaccinology at the University of Maryland School of Medicine, who helps lead one of the clinical-trial networks participating in the large vaccine studies.
Sanofi SA, which plans to begin testing its first Covid-19 vaccine in humans as early as September, is using algorithms and artificial intelligence to anticipate hot spots around the world where it can recruit patients.
“I am concerned that if you don’t choose the right sites and we don’t make the right predictions, we may not have successful studies,” said Sanjay Gurunathan, who oversees vaccine trials at the French company.
Among the areas being targeted in the U.S. and outside the country, industry officials say, are places where people generally aren’t following preventive measures like social distancing or wearing masks. Some testing sites for Pfizer’s vaccine trial will be in states that have seen recent increases in infections, such as Florida, Arizona and Texas, Pfizer Chief Executive Albert Bourla said during a recent online event hosted by the Milken Institute.
The NIH trial networks have previously been used for HIV or tuberculosis and are being adapted, said Dr. Collins, the NIH director. He said the government also created software that analyzes the network availability with Covid-19 community spread.
Benchmark Research, an Austin, Texas, company helping to run a midstage study of Moderna’s vaccine, is recruiting volunteers for phase 3 studies partly by calling schools, meatpacking plants and other places where the coronavirus could spread easily, Chief Executive Mark Lacy said.
To make it easy for people to participate in a trial, Benchmark will explore the unusual option of setting up vaccine-trial clinics at the sites, Mr. Lacy said. “We are entering uncharted territory,” he said.
After studies begin, the virus poses a challenge that will require health-care workers and study volunteers to take precautions. Both groups will be expected to wear protective gear including face masks at trial sites, Dr. Neuzil said.
NYU will speak to subjects via text or telephone, and may have them do self-swabs at home and send them to researchers by courier to limit exposure, Dr. Mulligan said.
“It’s a complex operation because you can’t ask sick people to get on the subway in New York City, where my clinics will be,” Dr. Mulligan said.