COVID-19 vaccine race heats up with clinical trials at 3 Michigan sites

The race for a COVID-19 vaccine is picking up as three medical centers in Michigan now are involved in Phase 3 clinical trials of three different vaccine candidates. The hope is at least one of them will prove to be safe and effective in preventing the disease that has killed more than 183,000 Americans.

Michigan Medicine announced Tuesday it is partnering with the British pharmaceutical company AstraZeneca to test a COVID-19 vaccine created by researchers at the University of Oxford and its spinoff company, Vaccitech. It works by using a modified and weakened version of a chimpanzee common-cold virus (adenovirus). The virus has been tweaked to contain the genetic spike protein found in SARS-CoV-2.

A Phase 3 trial also is underway at the Michigan Center for Medical Research in Farmington Hills to test the coronavirus vaccine created by Pfizer and German biotechnology company BioNTech. The vaccine uses messenger RNA, a copy of the SARS-CoV-2 genetic code, to trick the body into creating COVID-19 antibodies to fight off infection.

Henry Ford Health System also is in the midst of a trial of an mRNA vaccine developed by Massachusetts-based Moderna in conjunction with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.

The goal for all three trials will be to recruit 30,000 people across several sites nationally to test safety and immune responses to the vaccine.

President Trump has said his goal is to bring at least one effective coronavirus vaccine to market quickly — potentially as soon as this fall. To reach that goal, he announced Operation Warp Speed, a public-private partnership to develop and deliver 300 million doses of a COVID-19 vaccine available by January.

“The importance of a safe and effective vaccine against COVID-19 cannot be overstated," said Dr. Marschall Runge, dean of the U-M Medical School and executive vice president of Medical Affairs and CEO of Michigan Medicine.

"At the end of the day, this kind of rigorous clinical trial with the commitment of Michigan Medicine and other study sites to safety will be a key step in realizing a vaccine that will save lives when one is developed."

Here’s what’s happening in each of the three trials: 

AstraZeneca vaccine trials at U-M

Michigan Medicine is recruiting volunteers for the Phase 3 placebo-controlled trial of the AstraZeneca COVID-19 vaccine.

Those who enroll will have to make seven visits to the Ann Arbor-based health system over two years. One-third of those who participate will receive a placebo. Two-thirds will receive the vaccine. The injections will be administered in two doses spaced 29 days apart and participants will be followed over two years.

To qualify, you must be at least 18 years old, and in good or stable health. Those with underlying medical conditions may still participate in the trial if the disease is stable.

Participants cannot have or previously had COVID-19. To learn more or to enroll, go to: https://www.uofmhealth.org/covid19-vaccine or send an email message to: AZVaccineTrial@med.umich.edu. 

An earlier Phase 1-2 single-blinded, randomized controlled trial of the vaccine tested 1,077 adults between the ages of 18 and 55 in the United Kingdom and showed some success.

Each person received either a single or double dose of the COVID-19 vaccine or a single dose of a meningococcal conjugate vaccine as a control. It was tolerated and generated "robust immune responses against the SARS-CoV-2 virus in all evaluated participants," AstraZeneca reported.

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A single dose of the vaccine resulted in a fourfold increase in antibodies to the SARS-CoV-2 virus spike protein in 95 percent of participants one month after injection, according to a study published in The Lancet.

Everyone who received the vaccine showed a T-cell response that peaked by day 14 post-injection that was maintained two months after injection. There were no serious adverse effects.

Dr. Mark Schlissel, president of the University of Michigan, said in a statement that the university is proud to advance U-M's "outstanding legacy of excellence in vaccine trials with this important clinical trial partnership. We hope one day soon to be able to announce a successful vaccine against COVID-19 and save lives."

Pfizer/BioNTech vaccine trials at the Michigan Center for Medical Research

The Michigan Center for Medical Research is recruiting adults ages 18-85 for its Phase 3 randomized, placebo-controlled trial of the Pfizer/BioNTech COVID-19 vaccine.

One half of patients will receive a placebo, and the other half will receive two doses of the BNT162b2 vaccine spaced either three weeks apart or two months apart, said Dr. Steven Katzman, an internal medicine physician who is leading the trial in Michigan.

"So far, the tolerability that we've seen has been phenomenal," Katzman said of the few dozen patients who've already received injections as part of the trial. "It's so exciting."

The trial will close to new patients on Sept. 11. Katzman urged people — especially those from underrepresented communities such as African-American, Hispanic and Asian populations — to enroll quickly.

"Those are communities that have been really hit hard by coronavirus," he said.

Blood samples will be collected from patients and they will be followed for two years.

To learn more or to enroll, send an email to: FightCovid19@michmer.com or call 248-747-4383.

In an earlier Phase I/2 randomized trial of the vaccine, all who received it developed an immune response and had antibodies to SARS-CoV-2. No serious side effects were indicated, though some patients who received the vaccine reported fever, fatigue and chills.

If the vaccine gets U.S. Food and Drug Administration approval, some of the doses will be manufactured at the Pfizer plant in Kalamazoo.

Henry Ford Health's Moderna vaccine trial

Henry Ford Health System is no longer enrolling patients in its Phase 3 randomized, placebo-controlled trial of the Moderna mRNA-1273 Coronavirus Efficacy (COVE) vaccine.

The Detroit-based hospital system is one of about 90 sites across the nation involved in the late-stage double-blind study, and has recruited all the volunteers it needs.

Half the patients who enrolled received the vaccine. The other half received a placebo.

Those who got the vaccine were injected with two 100-microgram doses, spaced 28 days apart, and are to be followed for two years to see whether the vaccine offers protection from contracting the virus or reduces the severity of the disease.

The results of the Phase1 trial suggest it might. In that trial, preliminary data published in the New England Journal of Medicine showed that two doses of the vaccine given to 45 people one month apart produced a "rapid and robust" immune response.

Side effects from the lower doses of the vaccine were mild, and included fatigue, chills, headache or muscle pain. Some people reported fever after getting the second vaccine dose at the higher levels.

Contact Kristen Shamus of the Free Press at kshamus@freepress.com, Robin Erb of Bridge Michigan at rerb@bridgemi.com, or Kate Wells of Michigan Radio at katwells@umich.edu.