A large new research study at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) will evaluate how SARS-CoV-2 — commonly known as COVID-19 — impacts the immune system of cancer patients. The study is expected to advance the scientific community’s overall understanding of how effective the vaccine is for preventing COVID-19 infection, determine if the vaccine is less effective in cancer patients receiving certain therapies and how long the immunity lasts. Many cancer therapies impact the immune system, which can leave it temporarily or permanently more susceptible to infection. That, in turn, could result in higher susceptibility to infection, more severe infection and a higher chance of death from COVID-19 infections. OSUCCC – James researchers also note that there is no peer-reviewed published data available on how cancer therapy affects the efficacy of the COVID-19 mRNA vaccine in cancer patients because patients in active therapy were excluded from vaccine trials. Data for patients who were not in active therapy from major trials has not yet been reported; however, it is widely recommended that almost all cancer patients be vaccinated. “This is a complicated study that we developed in record time. A true Buckeye team effort. From concept to our first patient was about eight weeks. This was the hard work from more than 20 faculty and staff who were well-supported by leadership at all levels, and special credit to the OSU Wexner Medical Center vaccine staff at the Schottenstein Center who made this happen with no slow-downs for overall vaccine patient flow,” says Peter Shields, MD, co-principal investigator of the study and deputy director of the OSUCCC – James. He is also a professor in the Ohio State College of Medicine. “Our study will provide important data to confirm how effective the current COVID-19 vaccines are for preventing infection and transmission to others, which is a critical public health and economic question, especially for this high-risk population,” says Zihai Li, MD, PhD, director of the Pelotonia Institute for Immuno-Oncology at the OSUCCC – James. Li serves as co-principal investigator of the study and is a professor at the Ohio State College of Medicine. Study Method and Approach For this new study, OSUCCC – James researchers will enroll up to 450 cancer patients and 100 healthy volunteers aged 18 or older who are undergoing COVID-19 vaccination at The Ohio State Wexner Medical Center. Investigators in the study, which is known as SIIREN (Study of Infections and Immune Response), will particularly focus on how infection susceptibility and immunity change based on each patient’s stage of disease. Participants will be asked to provide weekly saliva samples by mail to test for COVID-19 infection and to provide blood samples to measure signs of immune response. Patients will also complete periodic written questionnaires about the vaccine, any associated symptoms they have experienced and potential COVID-19 exposures. Participants will be followed for a year. “Getting shots in arms to reach herd immunity so that — as a country — we can get back to some sense of normalcy is critical. Science has helped us rapidly mobilize to develop COVID-19 vaccines that are safe and effective at reducing severe illness and death in the adult general population, but there are substantial knowledge gaps we need to fill to provide the best protection to higher risk populations, including the more than 17 million cancer survivors in the United States,” adds Dr. Shields.