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Allina Health seeks volunteers for COVID-19 vaccine trial

Allina Health is running the only clinical trial site in Minnesota as part of Johnson & Johnson's COVID-19 vaccine study.

MINNEAPOLIS, Minnesota — As COVID-19 case records continue in Minnesota, a second COVID-19 vaccine trial is launching in the state. 

Allina Health is running the only clinical trial site in Minnesota part of Johnson & Johnson's COVID-19 vaccine study. The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine that is now in phase 3. 

"The issue is way more complex than just does the vaccine work or not," said Dr. Frank Rhame, an infectious disease specialist at Abbott Northwestern Hospital. "Because we care most about whether it works in people who have severe disease or moderately severe disease because they're the ones who really suffer." 

J&J's vaccine is one of four (soon to be five) now in phase 3 of clinical trials in the United States. In Minnesota, HealthPartners has also been enrolling participants in a COVID-19 vaccine trial, this one through AstraZeneca. 

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"We really need to understand how all five vaccines behave. This is our one chance to really do it in a placebo-controlled way," Dr. Rhame said. 

The J&J study is called ENSEMBLE. The goal is to enroll 60,000 participants worldwide. 

While Allina Health has had some participants walk through the whole process, the site official launches next week inside the Phillips Eye Institute Medical Office Building in Minneapolis. 

Allina Health's Infectious Disease Research team has been hard at work setting up the spaces. At the site, many COVID-19 safety precautions are in place for when people have to attend the initial four-hour visit. During that initial visit, volunteers will receive either the single dose vaccine or placebo at no cost. 

"I can't promise this vaccine is a good deal. If I did that I wouldn't be able to ethically randomize is against placebo. On the other hand, we have some good reasons to believe it's going to be safe because there's a lot of precedent for similar vaccines," Dr. Rhame said. 

Dr. Rhame said they also know participants in the first month after receiving the vaccine have antibody levels similar to those in people who have recovered from COVID-19. 

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Researchers want to make sure Black, Indigenous and people of color are significantly included in the trial. 

"We do know that COVID does affect folks, individuals of color, disproportionately. So we want to make sure that we do have an active role in that venue. So we have partnered with local community centers to do that," said Dr. Vani Nilakantan, vice president of research for the Allina Health System. 

Those part of the trial will have their progress followed for two years and one month. It includes eight visits; volunteers can choose if those happen at home or at the clinical site. 

So when could we see this vaccine available to everyone? It's tough to say because it depends on how phase 3 goes. However, J&J has said in the past that the goal is to make the first batches of its vaccine available for emergency use authorization in early 2021. 

"The entire world is resting on the success and safety of these vaccines and we hope to be part of that solution," Dr. Nilakantan said. 

You must be over 18 to volunteer. To see if you qualify, visit ensemblestudy.com

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