The clinical trial is sponsored by SeroNet, a national network dedicated to serological sciences

MINNEAPOLIS/ST. PAUL (06/21/2021) — Understanding the differences in COVID-19 vaccine immune response among immunocompromised patients is the focus of a new national study led, in part, by the University of Minnesota Medical School. Their arm of the study will compare immune responses in people with healthy immune systems alongside those with immunocompromised systems due to HIV, cancer therapies or a recent solid organ or hematopoietic stem cell transplant.

The study will be led by Amy Karger, MD, PhD, an associate professor of laboratory medicine and pathology at the U of M Medical School. She also leads some of the state’s COVID-19 testing and serology work out of the U of M Medical School’s Advanced Research and Diagnostic Laboratory.

“This study will help us understand which populations of immunocompromised patients may still be at risk for COVID-19 infection after vaccination due to a poor immune response to the vaccine,” Karger said. “That is important not only for counseling patients to maintain strict masking and social-distancing, but our data may also inform future approaches for improving sub-optimal immune responses, such as additional booster shots.”  

The national study is sponsored by the Serological Sciences Network (SeroNet), which is a major component of the National Cancer Institute’s response to the COVID-19 pandemic. In October, SeroNet designated the U of M Medical School as one of four national Capacity Building Centers that would work collaboratively with NCI and the Frederick National Laboratory for Cancer Research to rapidly deploy serological testing to the public and to improve the understanding of the immune response to SARS-CoV-2 and mitigate the virus’ spread.

The U of M Medical School research team will study the following unvaccinated or recently vaccinated study participants:

  • People with healthy immune systems;

  • People with HIV;

  • People who have recently received a solid organ or hematopoietic stem cell transplant;

  • Or, people who have recently received chemotherapy, immunotherapy, radiation therapy and/or targeted treatment for cancer.

The research team will study the participants over a two-year period, analyzing blood draws and mucosal swabs taken at different times throughout the study. Across the four national sites, the study hopes to enroll 2,000 people.

To learn about eligibility or to enroll in the study, visit seronet.umn.edu. Interested participants who are also patients with M Health Fairview will be prioritized for enrollment due to patient record access.

A total of 98.4% of the project will be financed with subcontract funds ($1,567,594), with $25,000 (1.6%) financed by nongovernmental sources.

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About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. We acknowledge that the U of M Medical School, both the Twin Cities campus and Duluth campus, is located on traditional, ancestral and contemporary lands of the Dakota and the Ojibwe, and scores of other Indigenous people, and we affirm our commitment to tribal communities and their sovereignty as we seek to improve and strengthen our relations with tribal nations. For more information about the U of M Medical School, please visit med.umn.edu. 

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