UW Hospital plans to enroll 1,600 people in a study of one of the leading COVID-19 vaccine candidates, research that will evaluate the effectiveness of the injection before it can be submitted for approval and potentially used to tame the pandemic.
The hospital is one of 100 sites expected to enroll 30,000 people nationwide in a phase 3 trial of the experimental vaccine against the coronavirus developed by British pharmaceutical company AstraZeneca and the University of Oxford. The first injections in the study were given last week in Florida.
Of three dozen experimental COVID-19 vaccines in human studies around the world, the AstraZeneca candidate is among nine in large-scale, late-stage trials, according to the New York Times. The federal government has provided up to $1.2 billion for the company to produce 300 million doses for the U.S., more than double the amount of support for two other candidates by Moderna Inc. and Johnson and Johnson.
“The focus is getting a vaccine that works so that the world can return to normal," said Dr. William Hartman, a UW Health anesthesiologist heading up the trial in Madison.
One or more COVID-19 vaccines could be approved and available by late this year or early next year, health officials have said, though no timeline is guaranteed and it's unclear how well any might work. Supply shortages would mean preferred groups of people would get vaccines first.
Starting Monday, UW Health will seek 1,600 people to sign up over the next eights for the study, in which they will receive two injections four weeks apart. Two-thirds of participants will get the experimental vaccine, known as AZD1222, and one third will get a placebo.
Participants and their doctors won't know which group they're in. The goal is to see if people who get the real vaccine are protected from infection after natural exposure to COVID-19 more than those who receive the placebo, and to analyze the length and strength of their immune response to the vaccine.
Though the vaccine has been developed and tested more quickly than usual, Hartman said the process has been safe. "It doesn't appear that any corners have been cut," he said. "It's moving swiftly, but not too quickly."
Hartman is also overseeing studies of an experimental antibody treatment for COVID-19 at UW Hospital. He has led the hospital's delivery of convalescent plasma, which uses antibodies from recovered patients to treat those struggling with infections.
It was UW Hospital's key role in a national study of convalescent plasma that led the hospital to become part of the AstraZeneca vaccine study, said Jennifer Parnell, clinical trials director of the UW Institute for Clinical and Translational Research.
Once enrollment in the AstraZeneca study is done, it's possible UW Health might be part of other COVID-19 vaccine trials. “We would be well poised to launch a second one," Parnell said.
The AstraZeneca vaccine uses a virus that causes common colds in chimpanzees, engineered to be harmless and contain the genetic sequence that encodes for a spike protein on the surface of the coronavirus. The protein primes the immune system to attack the virus if it later enters the body.
That is a common technique for vaccines but different from some COVID-19 vaccine candidates, such as Moderna's, which uses messenger RNA to deliver the viral protein.
The AstraZeneca vaccine generated an immune response in an earlier study of about 1,000 patients, according to a study published in July in the medical journal Lancet. About 60% of participants had side effects — such as fever, headaches or muscle aches — considered mild or moderate.
To be in the UW Hospital study, people must be at least 18 years old and healthy or have medically stable chronic diseases. They must not have had a previously confirmed diagnosis of COVID-19.
Enrollment initially will be limited to ages 18-55, but older people should be able to sign up later, Hartman said. UW Hospital aims to include communities disproportionately affected by COVID-19, including Blacks and Latinos, he said.
During the two-year study, enrollees will undergo physical exams, blood tests and COVID-19 tests.