It has been more than six months since the first COVID-19 case was found in the United States. The World Health Organization reports that since Jan. 20, there have been more than 6 million confirmed cases of the virus in the United States and the virus has been listed as the cause for more than 184,000 deaths.

As scientists search for a vaccine, clinical trials have started across the United States including one at the {span}University of Wisconsin-Madison School of Medicine and Public Health and its teaching hospital UW Health.{/span}

Dr. Jeff Pothof, UW Health’s chief quality officer, was the first person in the University Hospital’s clinical trial to receive an injection of the vaccine Sept. 2. Other participants are sought for the AstraZeneca COVID-19 study, with the intent to include 1,600 enrollees.

The Waunakee Tribune (one of The Courier’s sister publications) spoke with Pothof Sept. 3, and aside from some soreness in his arm where he received the injection, he said, “I feel pretty good.”

Pothof, like other participants, does not know if he received the actual vaccine or a placebo. He said previous studies have indicated about 60 percent of people receiving the vaccine reported some effects after three days, but 40 percent had no symptoms.

The Oxford University AstraZeneca clinical trial is now in phase 3. The phase 2 data included about 1,000 participants to study the side effects, which so far, have included muscle tenderness around the injection, headache and fever, what Pothof called “a really benign set of side effects that could easily be managed with Tylenol or even ibuprofen.”

On the flip side, the vaccine seems to be effective.

“When they test people’s blood to see if it does what good vaccines do to give immunity, it looks really promising,” Pothof said. “There’s usually two parts of our immune system that need to be activated to have a really good vaccine, and that is something called neutralizing antibodies and killer T-cells. And this vaccine does seem to produce those two components of our immune system that actually look like it could be effective for immunity of COVID-19.”

The phase 3 trial will include 30,000 people throughout the United States in hopes of determining its effectiveness. It will show if those who received the placebo begin to get COVID-19 in places where there are high rates of COVID-19 and those who received the vaccine do not.

“You need big populations to prove that. Further, with larger numbers, you can find out if there are just really, really rare side effects that you might not see if you do 1,000,” Pothof said.

UW Health and the University of Wisconsin School of Medicine and Public Health has proven to AstraZeneca and the regulators that is qualified to be a successful clinical-trial site, he added.

“We have a lot of infrastructure that makes us really good at doing these thing,” Pothof said.

Participants are being sought for the clinical trial. Those who volunteer for it will go through a phone screening to ensure they have no active underlying medical conditions and are not too old or young.

Those chosen as candidates will go to the hospital, or to other sites slated to open, for the consent process.

“The consent process is pretty detailed. We really want everyone to understand all the risks, all the benefits, to really get a good understanding of what the expectations will be,” Pothof said.

Time commitment will be one, as the study will span two years. Participants will be seen seven or eight times for lab draws. Virtual appointments may be made to see how participants are feeling.

“You get an app where you report symptoms for a couple weeks, and then intermittently throughout that,” Pothof added.

Pothof was tested both for the virus and for antibodies first to ensure that he has not had it.

If he develops symptoms of COVID-19 over the next two years, a device on his arm will be placed to measure his temperature, heart rate, blood pressure and other physiological responses to a COVID-19 infection.

Eventually, once the data has come in, participants will be informed of whether they received the vaccine or the placebo.

“I’ll be kind of documenting different things I feel and things like that for the next couple days,” he said.

Pothof said being chosen as the first participant in the UW study was accidental.

He has been working with the COVID incident command center and teams since the virus outbreak and had been talking to the principal investigator of this study and the plasma study.

“One of the things we talked about really early at UW Health is that we felt kind of a responsibility as an academic health center to try to take the lead in figuring out solutions for COVID-19,” Pothof said.

That has included studying treatment solutions with clinical trials around convalescent plasma, Remdesivir, and others. But the hope was also to be one of the lead organizations for a vaccine trial, he added.

Late in August, Pothof said, “the stars finally aligned.”

“There’s so much you need to prove to the regulators and the vaccine makers, in this case the AstraZeneca Oxford group, that would convince them... that we are a place that can do a really good job on vaccine trials,” Pothof said.

UW Health was approved fairly quickly and is one of the first sites. Dr. William Hartman, the principal investigator, then asked Pothof to be the first patient, and he quickly agreed.

Pothof said he wanted to be part of the solution.

His pride in UW Health also motivated him, he said, adding the hospital often goes “incognito” despite having one of the best programs in the county.

And he wants people to feel confident in the vaccine so that when it is widely available, they will be more likely to have one.

“A lot of people know who I am based on some of the media stuff I’ve done through the pandemic, and I wanted to reassure them that if I’ve looked at all the literature and I’ve looked at all the research, and I was willing to roll up my sleeve, that other people who fit the study protocol are low risk, they can feel confident in volunteering for this trial so we can could get a really safe and effective vaccine to market,” he said.

Pothof went into the study without much fear, saying he had been keeping track of this vaccine, which UW Health researchers had looked at from the beginning. He also had access to the research protocols.

“It was easy to put on the scale what I thought was a tremendous benefit to our community — and even broader, I mean at some point you think about whole world having a vaccine, it’s just an incredible thing – versus the risk, which is pretty small,” he said.

Asked how the vaccine works, he said the AstraZeneca Oxford University vaccine involves taking a cold virus that typically gives the common cold to chimpanzees and doesn’t make humans sick.

That inert virus was genetically engineered to produce only the spike protein of COVID-19, which he explained as “kind of like the machinery of COVID-19 that allows it to attach to human cells and inject its genetic material.”

The virus itself can’t harm a person but the spike protein is identical, and the immune system is able to identify and attack the protein.

“It basically shuts down COVID-19 or the SARS-CV-2 virus’ ability to infect cells,” Dr. Pothof said.

Meanwhile, researchers are working on finding a vaccine. Hundreds of other clinical trials are now underway worldwide, but most are in the preclinical phase, Dr. Pothof said, adding a handful are in the phase 2 stage.

Three that look most promising — the Oxford University AstraZeneca vaccine, and others by Pfizer and Moderna – are now in phase 3 trials.

“Even though there’s a whole bunch of them out there, it really boils down to these three as the most likely candidates for a vaccine in the U.S.,” Pothof said.

Usually, a phase 3 trial would continue for a few years to see how long the immunity lasts. But if early data comes back overwhelmingly showing that people who got the vaccine are free of the virus, while those with the placebo are getting infected, and there are no major adverse side effects, the vaccine could be approved without its lasting effectiveness known.

In that case, Dr. Pothof said, a vaccination program could be set up in the first quarter of next year.

“Two pieces will have to come together. You’ll have data that says, yes, this works, and then it’s going to be this shift to, did we make enough ahead of time and did we do enough planning, so we can actually get it administered to hundreds of millions of people?” Pothof said.

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