Phase 3 clinical trials of the long-awaited COVID-19 vaccine from Oxford are set to begin Tuesday in the United States, with participants in Madison, Wisconsin rolling up their sleeves for the injection.
The University of Wisconsin is one of dozens of test sites in the United States for a vaccine candidate, made by AstraZeneca in partnership with the British University of Oxford. Tuesday’s trial will mark the start of the third phase 3 study in the United States for a vaccine against COVID-19, after Moderna and Pfizer.
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The process began when President Donald Trump pressured to speed up vaccine research, hinting at some approval ahead of the early November election.
But Dr. William Hartman, an assistant professor of anesthesiology at UW Health and the University of Wisconsin-Madison School of Medicine and Public Health, does not expect preliminary data until at least Thanksgiving.
The first participant to register was UW’s Chief Quality Officer and emergency physician, Dr. Jeff Pothof. He is scheduled to receive the photo on Tuesday, but is not otherwise involved in the study.
“We’re all so tired of the coronavirus, and I think vaccine testing is really our best attempt to take offense against the virus,” Pothof said. “I just wanted to be a part of that decision.”
Pothof will be one of 250 people enrolled each week for the next eight weeks. Two-thirds of the study participants will receive the actual vaccine given twice at one-month intervals. The rest will receive a series of placebo photos.
“It takes at least a month to generate the antibodies we want to measure,” Hartmann said. “At this point, a second injection is given.”
Participants should be monitored for at least one month after the second shot to measure the level of antibodies to the coronavirus. Given this time period, it will be around Thanksgiving before the company has at least preliminary data, Hartman said.
But President Trump has repeatedly called for faster work on vaccine research. In a speech last week at the Republican National Convention, he promised the nation “to produce a vaccine before the end of the year or maybe even earlier.”
The researchers will monitor study participants for two years to determine how well the photos work and how long such protection can last. But they are likely to have a good indication of whether the vaccine is effective enough to justify an emergency use permit.
The Food and Drug Administration said the effective vaccine only needed to protect 50 percent of people to be considered effective.
The Oxford vaccine uses a well-known virus called adenovirus, which causes the common cold. It is genetically modified so that it does not make a person ill. Instead, it teaches the immune system how to generate antibodies to attack the so-called spike protein on the surface of the coronavirus. It is this protein peak that enters human cells, creating chaos.
“If we can close the door on these spiked proteins, there’s no way this virus can enter cells,” Hartmann said.
AstraZeneca is not the only manufacturer of medicines with a potential vaccine against COVID-19. The head of the National Institutes of Health, Dr. Francis Collins, said many vaccines would be needed to meet global demand.
“The NIH is committed to supporting several phase 3 vaccine trials to increase the chances of one or more being effective in preventing COVID-19 and putting us on the road to recovery from this devastating pandemic,” Collins said in a news release.
Moderna and Pfizer have already enrolled a total of about 30,000 participants for their phase 3 trials. The three companies are seeking to enroll 30,000 people each to determine if the vaccine is effective against infection with SARS-CoV-2, the virus that causes COVID- 19.
And Johnson & Johnson plans to include 60,000 entrants for its vaccine candidate.
Enrollment of such a huge number of participants – ideally with a wide range of ages and ethnicities – is done to ensure that researchers can detect rare side effects missed during earlier safety studies with fewer participants. .
“That’s why you don’t just finish the early trials and say, ‘OK, no one’s dead.’ Everyone looks good. You want to carefully analyze and analyze this data to ask, “Are there any surprises here?”, Explained Dr. Gregory Poland, an infectious disease expert and director of the vaccine research group at the Mayo Clinic in Rochester, Minnesota.
The AstraZeneca study will include “different racial, ethnic and geographical groups who are healthy or have stable basic medical conditions, including those living with HIV, and who are at increased risk of SARS-CoV-2 virus infection,” according to press release of the company.
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The test site at UW is likely to enroll a large number of students who have recently returned to campus for the fall semester.
Having a standard demographic characteristic for this study object – that is, otherwise healthy people in their late teens and early 20s – may be beneficial to researchers. To show that the vaccine really works, the study must show that people in the same demographics who were immunized did better than similar people who received a placebo.
“If we notice a low or no infection in those who have received the vaccine compared to their peers, it would be valuable information to help us understand if the vaccine is effective,” Pothof said.
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