By Carrie Rengers, the Wichita Eagle, original article link
In the race to find a COVID-19 vaccine, one of five major trials nationally will be conducted in collaboration with the KU School of Medicine-Wichita Center for Clinical Research along with more than 100 other testing sites nationally.
“We really do want to see if this vaccine is effective at preventing the spread of this disease,” said center director Tiffany Schwasinger-Schmidt, who is a physician and an assistant professor at the school.
She and others nationally and internationally are particularly hopeful for the vaccine that Oxford University developed and the biopharmaceutical company AstraZeneca purchased.
Schwasinger-Schmidt said the National Institutes of Health realized that a cross-country collaboration among researchers would be necessary to test this and other potential vaccines, and it developed the COVID-19 Prevention Network.
“This is where all the big vaccines are being developed,” Schwasinger-Schmidt said.
“A vaccine is just a way to expose your body’s immune system to a virus . . . so when your body gets exposed to that virus again, it can very quickly mount the defense mechanisms that it needs to fight that virus.”
The Lancet medical journal last month published an article on the AstraZeneca vaccine — one of almost 200 in the works.
KU-Wichita is partnering with the KU Medical Center and Children’s Mercy Kansas City to test 1,500 of the planned 30,000 study participants nationally.
The two-year trial most likely will start later this month.
Vaccines typically take years — even decades — to develop.
“Amazingly enough, since we learned about this virus within the last year, there has been a lot of research dedicated to it,” Schwasinger-Schmidt said.
Part of the reason it got such immediate attention is because it was so devastating from the beginning, she said.
Scientists quickly sequenced the virus and began to understand it. Schwasinger-Schmidt said they used technology that had already been developed with other vaccines.
“We’ve been able to take that technology and then rapidly develop a vaccine.”
Schwasinger-Schmidt said Oxford’s initial clinical trials of the vaccine, which happened in April and May, had 1,000 participants across the United Kingdom who saw a benefit without experiencing any serious adverse effects.
She said there were reports of mild effects, such as fatigue, headaches, sore muscles and low-grade fevers.
“But nothing serious when they were exposed to it,” Schwasinger-Schmidt said.
“It has the best data that we’ve seen that it’s safe and that (it’s) likely going to be effective.”
Still, even if it works, it’s going to be a long time before it would be available for general use.
“We know at minimum we’re going to have to have at least a year’s worth of data from these trials,” Schwasinger-Schmidt said.
That’s despite infectious disease expert Anthony Fauci, who is part of the White House Coronavirus Task Force, suggesting at one point a vaccine could be available by the end of this year.
“Dr. Fauci is the eternal optimist,” Schwasinger-Schmidt said. “That’s what I love about him. He’s one of the most brilliant people.”
However, she said she thinks “his optimism is a little aggressive for what we need to know about these vaccines.”
“Without data, we could be putting people in harm’s way, and that’s something none of us want to do,” she said.
“I don’t want to contradict the great Dr. Fauci, but I really want to make clear to everybody we’re doing these in the right way. . . . Unfortunately, that just takes time.”
HOW IT WORKS
Most potential COVID-19 vaccines focus on one specific part of the novel coronavirus: the spike protein on the exterior of the virus forming its recognizable “crown.” The spike protein is also the part of the virus that binds to human cells, facilitating its invasion and eventual takeover of your body’s cellular machinery.
Pharmaceutical research groups have taken different approaches to safely delivering the spike protein into the human body. AstraZeneca’s approach uses a modified kind of adenovirus — one of the viruses responsible for the common cold — to deliver the protein. This modified adenovirus produces the spike protein inside your body, but is engineered so that it can’t get you sick.
In addition to using this approach, KU is doing what’s called a placebo control trial.
“For every three participants we enroll, two will receive the vaccine and one will receive a placebo,” Schwasinger-Schmidt said.
At the trial’s conclusion, people who received a placebo will be able to get the vaccine.
KU and other test sites are seeking high-risk patients, including those over age 65, people who live in nursing homes or work in high-risk places such as at meatpacking plants, and people in higher-risk populations, such as Black and Latino communities.
There are two ways to apply to participate in the trial.
One is by calling the Center for Clinical Research at (316) 293-1833 to be screened for eligibility.
The other is through the COVID-19 Prevention Network website at www.coronaviruspreventionnetwork.org. Potential participants should select KUMC as the testing site and then answer a few questions.
Participants will be compensated, though it hasn’t been determined how much yet.
Schwasinger-Schmidt said she had a neighbor ask her if she would feel confident enough to be part of the trial and take the vaccine.
“My answer without hesitation was, ‘Absolutely.’ ”
She said she wouldn’t conduct the trial “unless I believe in the research.”
“Our number-one concern is always looking at safety.”
HERO PARTICIPANTS
Even with so many safety considerations, Schwasinger-Schmidt said she believes “the people who volunteer for clinical trials truly are heroes.”
She said the word “hero” is tossed around a lot, especially lately, but Schwasinger-Schmidt said she believes “there’s no better definition” than volunteer participants.
“Without them, we would not be able to understand the virus. We would not be able to move forward in developing these vaccines.”
Participants will get the vaccine on the first day and a second, booster vaccine a month later.
Schwasinger-Schmidt said the initial trial found that second round “really helped boost their immune response and antibodies against the virus.”
Participants will make a total of nine visits to the clinic, most of which will be in the first year. A mobile unit also will be available to enroll people in high-risk areas.
Participants have to also be out in public regularly — not completely quarantining at home. Also, if they have had a lab-confirmed case of COVID-19, they are not eligible to participate.
Participants will have blood samples drawn throughout the trial and will be monitored if they become ill.
The Federal Food and Drug Administration will evaluate the study and determine if the vaccine will be approved.
Schwasinger-Schmidt said the National Institutes for Health is working with five pharmaceutical companies on five leading vaccines that are in development.
Moderna already started its trial, AstraZeneca’s is next followed by three more with Janssen, Novavax and Sanofi.
So far, the AstraZeneca trial is the only one KU is involved with, though Schwasinger-Schmidt said it may consider others.
She said she isn’t sure how much the AstraZeneca trial will cost.
“There is a lot of money that is going into this. We know that this is a priority.”
Contributing: Katherine Dynarski.
This article was republished here with the permission of: The Wichita Eagle