© Bill McCullough for The Wall Street Journal
Vaccine researchers are testing new tactics in an unprecedented effort to recruit the tens of thousands of healthy volunteers needed to finish testing coronavirus injections in the later stages of development.
Quickly aligning all subjects for so many studies at the same time poses several challenges, creating competition between companies.
Given the urgency, researchers are taking unusual steps, such as recruiting at pharmacies, recruiting churches in search of issues, and even asking employees and families to ask.
The researchers are also implementing algorithms to target recruitment in places at risk of being hit with the virus.
Get news and insights about politics, politics, national security and more, right in your inbox
Finding patients will be crucial in conducting trials to assess whether experimental vaccines safely protect against the virus. The general population cannot begin receiving vaccines until the vaccines are approved in trials.
Trials must enroll enough patients, in enough different parts of the US and abroad, so that there are enough numbers for the virus for researchers to measure whether it works.
So many vaccines are approaching the critical testing phase that researchers and companies feel they must take extraordinary steps to recruit all the necessary subjects.
“We not only have to find the number of volunteers, but they must be in an area where the virus is currently spreading; otherwise, you will not learn anything about the vaccine’s effectiveness,” said the director of the National Institutes. of Health Francis Collins in an interview. .
“It is a big task, and it means putting together as much clinical trial capacity as we can,” he added.
Vaccines are the best way to stop the spread of the new coronavirus from health authorities and scientists. Dozens are being developed to increase the chances that some will show that they work, and then they can be delivered as widely and quickly as possible.
Several coronavirus vaccine candidates have shown promise in small initial studies, but have yet to be tested in thousands of additional patients before regulators allow them to become widely available.
Typically, drug makers recruit patients to test potential products through advertising, 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 almost 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 NYU Langone Health Vaccine Center, which will participate in advanced-stage trials and is dedicating additional clinics for testing. .
Several of the final stage, or phase 3, trials are expected to begin in the coming weeks, after what researchers and industry officials describe as a remarkably quick timeline for designing the vaccines and studying their safety, dosage and signs of effectiveness in previous phases. .
The United States federal government plans to fund three trials of 30,000 people starting this summer: the Moderna Inc. vaccine starting this month, followed in August by a vaccine co-developed by the University of Oxford and AstraZeneca PLC, and in September, a vaccine developed by Johnson & Johnson. The Oxford vaccine recently began testing at advanced stages outside of the U.S.
Pfizer Inc. and its partner BioNTech SE plan to start their own 30,000-person trial of their vaccine this month as well.
The researchers have planned to enroll more subjects than are typical in vaccine trials to ensure that enough people are exposed to the virus so they can quickly determine if the vaccines work safely, Dr. Mulligan said.
The scale is so large that it means that trials are effectively competing with each other for recruits.
“A volunteer cannot be in two different studies. It’s a zero-sum game in that regard, “said Dr. Joseph Kim, CEO 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 test patients, is looking for busy Covid-19 test sites, including public health departments, test labs and pharmacies, to find healthy volunteers, said Kent Thoelke, chief scientific officer for PRA.
The Cincinnati Children’s Hospital Medical Center, which is preparing to test the Oxford injection, contacts non-Covid trial participants, e-mails the 16,000 hospital employees, urges them to contact friends and family, and follows 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, a professor of pediatrics at the hospital.
“We are doing everything possible,” he said. “I want to do it so that if people want the opportunity to participate, they can.”
To complicate recruitment efforts, industry officials say, it is making sure not only that the trials reach a specified number of subjects, but also include a sufficient number of elderly, ethnic minorities and other participants at increased risk of infection. Public health officials have said that 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 that the trials include high-risk populations. The hospital plans to send mobile physician offices to retirement communities.
Speed is a concern. Trials cannot end until enough vaccinated volunteers are exposed to the virus in everyday life. To quickly meet that goal, researchers are trying to identify areas at risk for virus spread and recruit there, said Kathleen Neuzil, a vaccination professor at the University of Maryland School of Medicine, who helps run one of the networks. from clinical trials participating in large vaccine studies.
Sanofi SA, which plans to start testing its first Covid-19 vaccine in humans in early 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 correct predictions, we may not have successful studies,” said Sanjay Gurunathan, who oversees vaccine trials at the French company.
According to industry officials, among the areas that are under attack in the US and outside the country, there are places where people generally don’t follow preventive measures like social distancing or wearing masks. Some test sites for the Pfizer vaccine test will be in states that have seen recent increases in infections, such as Florida, Arizona and Texas, Pfizer CEO Albert Bourla said during a recent online event hosted by the Institute Milken.
NIH test networks have previously been used for HIV or tuberculosis and are being adapted, said Dr. Collins, director of the NIH. He said the government also created software that analyzes network availability with the Covid-19 community broadcast.
Benchmark Research, an Austin, Texas company that helps conduct a modern-stage study of the modern vaccine, is recruiting for phase 3 studies, in part by calling schools, meatpacking plants, and other places where the coronavirus It could easily spread, Chief Executive Officer Mark Lacy said.
To make it easier for people to participate in a trial, Benchmark will explore the unusual option of setting up vaccine trial clinics at the sites, Lacy said. “We are entering unknown territory,” he said.
After the studies begin, the virus poses a challenge that will require precautionary health workers and study volunteers. Both groups are expected to wear protective gear, including face masks at test sites, Dr. Neuzil said.
NYU will speak to subjects by text message or phone, and you can ask them to make a swab at home and send them to investigators by courier to limit exposure, Dr. Mulligan said.
“It is a complex operation because sick people cannot be asked to get on the subway in New York City, where my clinics will be,” said Dr. Mulligan.
Write Jared S. Hopkins at [email protected] and Peter Loftus at [email protected]
Keep reading
