IOWA CITY — The University of Iowa will start giving trial coronavirus vaccines to volunteers Thursday as part of a research study investigating a potential inoculation against deadly COVID-19.
The trial — sponsored by Pfizer and BioNTech, two companies working in concert — aims to enroll 30,000 healthy volunteers willing to take the “investigational” vaccines, which the U.S. Food and Drug Administration hasn’t formally approved because they’re being tested.
The UI portion of the trial will involve about 250 volunteers ages 18 to 85 who are generally healthy, not pregnant, and have jobs or engage in activities that put them at heightened risk of contracting COVID-19, according to Patricia Winokur, executive dean of the UI Carver College of Medicine and principal investigator for the UI trial site.
Examples of those high-risk jobs include food industry workers and front-line health care providers, she said.
“It is important to enroll a diverse population to ensure that the vaccine is equally effective in different ages, races, genders,” Winokur said.
The study’s vaccines, aiming to help a body produce antibodies to fight off the disease, will be given by injection, according to a UI Vaccine Research and Education summary of the trial.
“These vaccines are all slightly different but work in the same way,” the summary said. “The study also will test each of these vaccines at different dose levels (amounts of vaccine).”
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In stressing the impetus for the investigation, the university notes COVID-19’s global spread — it has infected 16.8 million internationally, 4.4 million in the United States and nearly 43,200 people in Iowa so far. It has killed over 661,300 globally, 149,400 nationally and 844 in this state.
According to Winokur and the UI trial summary, participants will receive either a test vaccine or a placebo that looks like the study vaccine but does not contain active ingredients. For this trial, the placebo will contain saline.
Everyone in the study will get two injections. For every one person who receives the vaccine, another person will get a placebo. The two injections will come either three weeks or two months apart, according to the university.
A participant could be in the study for up to 26 months and would need to visit a study site at least six times, plus any time after experiencing COVID-19 symptoms and after feeling better.
Enrollment aims to finish in three months.
“We have received vaccine for a portion of the subjects who will be enrolled at Iowa and additional doses will be shipped as we use up our initial allocated stock,” Winokur said.
Trial participants must give about 25 ml of blood five times over the study duration — used to test antibody levels, according to the university.
“And we will be soliciting information on whether the participants have evidence of sore arm, fever, muscle aches from the vaccine, and then will be evaluating for evidence of COVID infection throughout the study,” Winokur said, stressing that participants will be followed for two years “to see if they develop symptoms of COVID.”
Researchers also will be taking nasal swabs to check for new illnesses consistent with COVID “because half of subjects will be getting a placebo and half will be getting the active vaccine.”
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They’ll compare onset of COVID-19 infection between the test groups, and they’ll evaluate antibody responses.
“But the true test is the ability to prevent infection,” Winokur said.
UIHC has been at the forefront of COVID-19-related research since the illness began its spread nationally — affording it the opportunity to offer trial treatments to its coronavirus patients, including convalescent plasma and Remdesivir.
The National Institutes of Health this week announced the start of the country’s first large clinical trial to investigate a COVID-19 vaccine — codeveloped by biotechnology company Moderna Inc., and the National Institute of Allergy and Infectious Diseases. That trial is expected to enroll about 30,000 adults who don’t have COVID-19.
A New York Times report on the trial indicates researchers will observe whether fewer vaccinated people contract COVID-19 and also whether the vaccine can avert severe cases of the disease and death.
That Times report mentions Pfizer’s recent announcement it, too, has begun a late-stage COVID-19 vaccine study, working with BioNTech to enroll 30,000 people from 39 states in this country, Brazil, Argentina and Germany.
The federal government last week announced a $1.95 billion deal to buy 100 million doses of the Pfizer vaccine by year’s end if the trial proves successful.
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