Project leaders believe the study will advance the scientific community’s overall understanding of how effective the SARS-CoV-2 mRNA vaccine is in preventing COVID-19 infection, determine whether the vaccine is less effective in cancer patients receiving certain therapies and shed light on how long immunity lasts.
Many cancer therapies impact the immune system, which can leave it temporarily or permanently more susceptible to infection. These therapies could result in more severe infection and a higher chance of death from COVID-19 infections.
Co-principal investigators for the study, which is known as SIIREN (Study of Infections and Immune REspoNse), are Peter Shields, MD, deputy director of the OSUCCC – James, and Zihai Li, MD, PhD, director of the Pelotonia Institute for Immuno-Oncology (PIIO) at the OSUCCC – James. When the study began, the researchers noted that there was no peer-reviewed published data on how cancer therapy affects the efficacy of the COVID-19 mRNA vaccine because cancer patients receiving active therapy were excluded from vaccine trials. Major trials had not specifically reported on outcomes in cancer patients not receiving active therapy; however, it is widely recommended that almost all cancer patients be vaccinated.
“This is a complicated study that our team developed in record time; from concept to our first patient was about eight weeks,” says Shields, a professor in the Division of Medical Oncology at Ohio State and member of the Cancer Control Program at the OSUCCC – James. “This was hard work from more than 20 faculty and staff who were well-supported by leadership at all levels, and special credit also goes to the Ohio State Wexner Medical Center vaccine staff at the Schottenstein Center who made this happen with no slow-downs for overall vaccine patient flow.”
“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. It is also one of the largest prospective clinical trials to examine the immune response of cancer patients to the COVID-19 mRNA vaccines,” says Li, a professor in the Division of Medical Oncology at Ohio State and a member of the Translational Therapeutics Program at the OSUCCC – James.
SIIREN Study Method and Approach
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. The investigators will focus on how infection susceptibility and immunity change, based on the patient’s stage of disease and treatment regimen.
Participants will provide weekly saliva samples by mail to test for SARS-CoV-2 infection and will provide periodic blood samples to comprehensively measure immune response. Patients will also complete periodic written questionnaires about the vaccine, any associated symptoms and potential COVID-19 exposures. Study investigators will monitor participants for a year.
As of mid-June, 28 individuals were enrolled in the trial, including 18 patients with cancer and 10 control individuals.
“Getting shots in arms to reach herd immunity so that — as a country — we can get back to some sense of normalcy is critical,” Shields says. “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.”
To learn more about participating in the SIIREN study, visit cancer.osu.edu/SIIREN. This study is supported by funds from the OSUCCC – James and from Pelotonia, the annual cycling event that raises millions of dollars for cancer research at Ohio State.