New Study to Examine COVID-19 Vaccines in People with Weakened Immune Systems

Researchers at the University of Wisconsin (UW) School of Medicine and Public Health are exploring the ideal vaccine booster strategy for immunosuppressed patients to protect those at higher risk of severe illness and complications from COVID-19 infection. The goal of the trial titled Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations, or ARMOR, is to determine whether a recombinant booster COVID-19 vaccine dose will improve sustained immunity against the virus that causes COVID-19 in people who live with inflammatory bowel disease (IBD) or solid organ transplant recipients and whose medical treatments involve staying on immunosuppressive drugs.

Participants who enroll in this trial will receive the Novavax COVID-19 vaccine, which is a recombinant vaccine and differs from the Pfizer or Moderna drugs in that it directs the immune system to recognize specific pieces of the virus. Studies have shown that those who receive immunosuppressive medications such as corticosteroids are at a higher risk for severe COVID-19 if they are infected, according to Freddy Caldera, DO, MS, associate professor of medicine at the UW School of Medicine and Public Health and gastroenterologist at UW Health.

The trial is taking place at University Hospital in Madison. Participants will receive the Novavax vaccine and have their blood drawn three times, once prior to vaccination, once 30 days after vaccination and once six months after vaccination. Researchers will assess immune system response after vaccination by evaluating levels of antibodies and T cells. The cost of the vaccination is covered by the trial.