A network of more than 100 clinical trial sites at hospitals and medical clinics across the United States will take on the unprecedented challenge of testing COVID-19 vaccines and other preventive treatments, federal officials announced Wednesday.
The COVID-19 Prevention Trials Network, which knits together existing federal clinical trial infrastructure developed largely to test HIV vaccines and treatments, launched with a website for volunteers to join the roster of people to be considered when the first trials begin later this month.
The scientific effort to develop a COVID-19 vaccine will depend crucially on tens of thousands of volunteers, in a gargantuan scientific, medical and logistical undertaking, with the aim of providing "substantial quantities of a safe, effective vaccine by January 2021," Health and Human Services Secretary Alex Azar said in a statement.
Testing a vaccine is a conceptually simple idea, but it is a careful and methodical process that unfolds through a phased system of trials that grow progressively larger. Early clinical trials, some of which have reported encouraging results, assess the right dose of the vaccine and monitor for any safety concerns in dozens or a few hundred patients. But the ultimate test of these vaccines will be large trials designed to test whether they are effective at preventing or reducing the severity of disease.
The first late-stage vaccine trial, in which 30,000 people will be randomly assigned to receive either an experimental vaccine made by the biotechnology company Moderna or a placebo, is expected to begin in the second half of July. There are expected to be at least five such large vaccine trials conducted through the network over the coming months - as well as trials of other preventive measures, such as monoclonal antibody drugs.
"This is what we do for a living and have done for a living," said Larry Corey, a virologist and past president of the Fred Hutchinson Cancer Center, who is co-leading the trial network. "We have a considerable infrastructure, probably the country's biggest infrastructure in vaccines."
Launching trials of this scale in such a short time requires the coordination of a long list of details, to ensure that the data is consistent across many different locations.
In the Moderna trial, 30,000 volunteers will be followed for two years, and will be asked to keep a diary of symptoms and be available for weekly check-in phone calls, according to Richard Novak, chief of the Division of Infectious Diseases at the University of Illinois at Chicago College of Medicine, who said he will be recruiting 1,000 volunteers for that study.
"It really is an intense effort," Novak said. The infrastructure needed ranges from equipment that is regularly audited to show that freezers never fail, staff to screen potential participants, setting up a call center to facilitate thousands of check-ins, to building the bridges to the community to ensure that a diverse array of people - and particularly those at greatest risk of covid-19 - sign up.
"Getting this up and running is a 24/7 job," Novak said.