University of Chicago Medicine looking for 2,000 participants for COVID-19 vaccine trial

University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.



Medical assistant Debbie Turrise assists patients driving thru with self administered COVID-19 tests at a COVID-19 drive-thru testing site at Rush University Medical Center in Chicago, Tuesday, Oct. 20, 2020. University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.


© Antonio Perez / Chicago Tribune/Chicago Tribune/TNS
Medical assistant Debbie Turrise assists patients driving thru with self administered COVID-19 tests at a COVID-19 drive-thru testing site at Rush University Medical Center in Chicago, Tuesday, Oct. 20, 2020. University of Chicago Medicine will soon begin testing another potential COVID-19 vaccine, and is looking for up to 2,000 people to enroll in the phase three clinical trial.

The trial is designed to evaluate the safety and efficacy of a single dose of a vaccine produced by Janssen Pharmaceutical Companies of Johnson & Johnson. The trial began enrolling 60,000 adults across the world in September.

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It’s one of a handful of potential vaccines now in advanced clinical trials in the U.S.

The international trial of the Janssen vaccine was temporarily paused in October after one participant developed an unexplained illness.

“Such pauses are not uncommon in vaccine trials, and late last week the FDA approved the resumption of the trial after an independent committee found the vaccine did not cause the illness,” University of Chicago Medicine leaders wrote in an email sent Monday to faculty, staff and students.

This is the second COVID-19 vaccine trial University of Chicago Medicine has offered. Since mid-September, the system has also been enrolling subjects in the Moderna COVE trial.

To participate in the Janssen trial and future research, people can join UChicago Medicine’s registry.

Other large hospital systems in Chicago are also participating in COVID-19 vaccine trials, including the University of Illinois at Chicago, which is part of the Moderna trial, and Northwestern Medicine, which is part of a trial of the AstraZeneca Oxford vaccine.

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Moderna hails diversity of Covid trial participants

Biotech firm Moderna said Thursday that it had successfully recruited ethnic minorities, older people and those with underlying health issues for its Covid-19 vaccines trial, after it pushed to enrol groups most vulnerable to the virus.

Moderna said it had now signed up all 30,000 participants for the phase-3 trial, and more than 25,000 of them had already received a second dose of the vaccine, four weeks after the first.

The firm said it was working “to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by Covid-19.”

More than 7,000 people taking part in the trial are over 65, and more than 5,000 under 65 have high-risk diseases such as diabetes, severe obesity and cardiac disease.

The firm said more than 11,000 are “from communities of color, representing 37 percent of the study population and similar to the diversity of the US at large” — 6,000 are Hispanic or Latino, and more than 3,000 are African-American.

Massachusetts-based Moderna is one of the few companies to have launched a large-scale clinical trial less than 10 months after the genetic sequencing of the novel coronavirus was established.

Some Chinese, Russian and other Western projects are also in advanced tests, including US firm Pfizer.

Moderna hopes to have sufficient results by the end of November and to then file an emergency authorization request with the US Food and Drug Administration (FDA).

The company has already said it was aiming to file for authorization soon after November 25, with Pfizer at the third week of November.

The US government says it will distribute the first doses immediately after authorization free of charge.

Health Secretary Alex Azar said Wednesday there would be enough doses to vaccinate the “most vulnerable” Americans before the end of the year, then the elderly and health workers in January, and all Americans by early April.

In the trials, half of the volunteers receive a placebo, and the other half get the vaccine.

Initial FDA guidance stipulated that if the number of participants in the vaccinated group naturally contracting the virus and falling ill with Covid-19 was at least 50 percent lower than in the placebo group, the vaccine would be declared effective.

But on Thursday, a National Institutes of Health official said during a meeting of the FDA’s advisory committee on vaccines that they would require a 60 percent efficacy for emergency use.

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Moderna’s coronavirus vaccine trial is fully enrolled, 37 percent of participants are minorities

“I think that we have done quite well — I think the demographics of the Moderna trial have markedly changed,” Larry Corey, a virologist at Fred Hutchinson Cancer Research Center said in an interview last week. Corey is heading up the clinical trials under Operation Warp Speed, the federal effort to speed vaccine development.

“We hope that we continue to improve upon that, this is the first trial,” Corey said. ‘There are two others in the field, and two more scheduled to go — so our journey in covid-19 vaccines is just starting.”

Pharmaceutical giant Pfizer’s coronavirus vaccine trial is also nearing completion. Pfizer’s trial, which is not part of Operation Warp Speed, has enrolled 39,862 of its planned 44,000 participants. Of those, 34,601 have received their second, booster dose.

Half the participants in both trials receive the study vaccine and half receive a placebo, and more than 25,000 of Moderna’s participants have already received their second dose.

More than half of the volunteers in Moderna’s trial are healthy and not at high risk of severe covid-19, the disease caused by coronavirus. But 25 percent are at elevated risk due to age and 17 percent are younger, but have conditions such as diabetes or obesity that put them in a high risk group.

Moderna has projected having early data in the next month that may show whether its vaccine is effective. The company will determine whether that data is sufficient to apply for regulatory authorization once it has accumulated two months of safety follow-up on half the study participants, a milestone anticipated slightly before Thanksgiving.

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