A Prospective study Evaluating COVID-19 Vaccine immunogenicity in Organ Transplant Recipients (the PREVenT-COVID study) – Pediatric Arm extension.
When the initial results from the COVID-19 vaccines showed they were upwards of 80 per cent effective in preventing serious illness and hospitalization, everyone was optimistic and excited, except for those with underlying medical conditions and their families. No one knew how well vaccines would work to protect people such as transplant recipients who are on immunosuppressant drugs to prevent rejection. There was even less data for children with organ transplants.
“We have learned more about the amount of protection the vaccines provide to adult transplant recipients, and that is what public health officials are currently using to guide their recommendations for children,” says pediatric infectious disease specialist Dr. Hana Mitchell. “But children are, of course, different from adults, and their immune systems are different from an adult’s immune system.”
The PREVenT COVID study will help researchers understand how much protection (antibodies and T-cells) children with organ transplant have after vaccination and how long this protection lasts. This information will help public health officials make recommendations about additional doses of vaccines for this population.The study team will also be able to document vaccine side effects experienced by children with organ transplant. Researchers will follow approximately 40 children and youth with organ transplant from Alberta, British Columbia, and Ontario for twenty-four months from their first dose of COVID-19 vaccine.
The Government of Canada COVID-19 Immunity Task Forcehas funded the first year of this study. The Addison Fund for Pediatric Transplant Research is supporting theexpanded second year of the project.
Addison’s mom, TRF Board Co-Chair Elaine Yong, says “Right now, we have no idea if Addison’s three doses of vaccine are providing any protection at all. The answers Dr. Mitchell and her team find over the extended period of time will provide crucial information that transplant kids and their families really need to know to help keep our kids safe. We are really excited to support this work!”
The objectives for Phase 2 of the PREVenT COVID-19 pediatric studyare as follows:
Determine persistence of immune responses to authorized COVID-19 vaccines in 40 pediatric SOT recipients at 18 and 24 months after receiving first dose of vaccine.
Continue to assess the safety of COVID-19 vaccines in 40 pediatric SOT recipients, including documentation of rare, SOT-specific safety concerns such as rejection.
Determine the incidence of COVID-19 infection occurring at least 14 days after the first dose of COVID-19 vaccine and after any subsequent doses (regardless of time elapsed) in pediatric SOT recipients.