A national research study has just launched to investigate the effectiveness and safety of COVID-19 vaccines in transplant recipients. The Government of Canada, through its COVID-19 Immunity Task Force (CITF) and Vaccine Surveillance Reference Group (VSRG), is investing over $2.84 million in this research study, based at University Health Network and called PREVenT COVID, short for Prospective Evaluation of COVID-19 Vaccine in Transplant Recipients: A National Strategy.
“Because people who have received a solid organ transplant and other immunosuppressed individuals, are generally excluded from clinical trials of vaccines, little data exists to guide clinical best practices for these populations,” says Dr. Deepali Kumar, project lead, Clinician Investigator at the Toronto General Hospital Research Institute and Director of Transplant Infectious Diseases at the Ajmera Transplant Centre. “Our research will address this knowledge gap by revealing how transplant recipients—who are on immune-suppressing medications to prevent organ rejection—respond to COVID-19 vaccines. We will compare their immune responses to non-transplanted individuals as well as those who have contracted COVID-19.”
With this funding, Dr. Kumar’s team will launch this study across multiple transplant centres to examine short- and long-term antibody responses in transplant recipients following first and second doses of COVID-19 vaccines. The team will compare these responses to those of healthy individuals who have not undergone transplant and those of transplant recipients who naturally contracted COVID-19.
The team will also assess the short- and long-term safety profile of vaccines in transplant recipients, tracking the rates of local and systemic reactions, organ rejection and other transplant complications.
“People who have received an organ or stem cell transplant may have unique immunization needs. For example, we do not know whether the effectiveness of vaccines differs depending on the timing of immunization relative to transplant,” explains Dr. Kumar.
The researchers will then develop a national COVID-19 vaccination safety surveillance system for transplant recipients. This system will build upon the Canadian National Vaccine Safety Network, an ongoing Canada-wide vaccine safety surveillance initiative.
“Our goal is to help coordinate the efforts of provincial and national organizations that are involved in public health and vaccination research and facilitate information sharing among public health agencies and patient partners,” says Dr. Kumar. “This research will build on Canada’s leadership in transplant medicine and inform health policy to best protect transplant recipients from COVID-19.”
COVID-19 vaccination remains one of the most effective ways to protect ourselves and others from COVID-19. This is why vaccination is important for the general population around immunosuppressed individuals who may have a reduced immune response to any authorized COVID-19 vaccine series.
“It is imperative that we study the immune response and safety of vaccines not only in the general population, but in populations with specific health issues, such as persons having received organ transplants,” says Scott Halperin, Co-Chair of the Vaccine Surveillance Reference Group. “We need to ensure that vaccines are working in vulnerable Canadians: studies like this will help to inform us whether a booster dose is needed in this specific population.”
The Canadian Donation and Transplantation Program (CDTRP) provided the infrastructure support essential for national alignment for this multi-site initiative, uniting nine study sites across Canada, including all solid organ and stem cell transplants in both pediatric and adult transplant recipients.
“Our well-developed network and supporting CDTRP infrastructure allowed us to work quickly and smoothly to unite efforts of many researchers and public health experts across the country to address these critical research questions,” says Dr. Lori J. West, Scientific Director for the CDTRP. “Working together, we were able to mobilize quickly and begin generating the knowledge urgently needed to inform patients, families, and public health policy,” adds Dr. Marie-Josée Hébert, Scientific Co-Director of the CDTRP.
About University Health Network
University Health Network consists of Toronto General and Toronto Western Hospitals, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, and The Michener Institute of Education at UHN. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. University Health Network has the largest hospital-based research program in Canada, with major research in cardiology, transplantation, neurosciences, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. University Health Network is a research hospital affiliated with the University of Toronto. For more information: www.uhn.ca.
About the Ajmera Transplant Centre at the University Health Network (UHN)
As the largest and most comprehensive transplant program in Canada, the Ajmera Transplant Centre performs over 600 transplant surgeries every year, including lung, heart, liver, kidney, pancreas and small bowel transplantation. For more information, visit: UHNtransplant.ca.
About the Vaccine Surveillance Reference Group
The Vaccine Surveillance Reference Group (VSRG) supports the monitoring of the safety and effectiveness of COVID-19 vaccines in Canada. It is a consortium of Canadian organizations—the Public Health Agency of Canada (PHAC), the Canadian Immunization Research Network (CIRN), the National Advisory Committee on Immunization (NACI), and the COVID-19 Immunity Task Force (CITF)—working collaboratively to pool expertise on vaccine surveillance. The VSRG reports to PHAC and is supported by the CITF Secretariat. It is co-chaired by the leader CIRN and the former chair of NACI. Among its responsibilities, the VSRG, through the CITF Executive Committee, makes recommendations to PHAC on funding research teams that can address important aspects of the immune response, safety, and effectiveness of COVID-19 vaccines with public health relevance and with attention to all priority groups.
About the COVID-19 Immunity Task Force
The Government of Canada established the COVID-19 Immunity Task Force in late April 2020. The Task Force is overseen by a Leadership Group of volunteers that includes leading Canadian scientists and experts from universities and healthcare facilities across Canada who are focused on understanding the nature of immunity arising from the novel coronavirus that causes COVID-19. To that end, the CITF is supporting numerous studies to determine the extent of SARS-CoV-2 infection in Canada (in the general population as well as in specific communities and priority populations), understand the nature of immunity following infection, develop improved antibody testing methods, and help monitor the effectiveness and safety of vaccines as they are rolled out across Canada. The Task Force and its Secretariat work closely with a range of partners, including governments, public health agencies, institutions, health organizations, research teams, other task forces, and engages communities and stakeholders. Most recently, the Task Force has been asked to support vaccine surveillance, including monitoring vaccine effectiveness and safety, as part of its overall objective to generate data and ideas that inform interventions aimed at slowing—and ultimately stopping—the spread of SARS-CoV-2 in Canada. For more information visit: www.covid19immunitytaskforce.ca
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