Study results directly impact clinical practice with robust evidence supporting current guidelines for SARS-CoV-2 vaccination starting three months post-HCT.
MINNEAPOLIS, MINN., May 24, 2023 – Results from a joint study between CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a research collaboration between the National Marrow Donor Program® (NMDP)/Be The Match® and the Medical College of Wisconsin (MCW)—and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) defining COVID-19 vaccine response in allogeneic hematopoietic cell transplantation (HCT) were recently published in eClinicalMedicine.
The multi-center, prospective, observational study measuring the safety and immunogenicity of SARS-CoV-2 (COVID-19) vaccination within 12 months after allogeneic HCT showed that COVID-19 vaccination is safe and elicits similar immune responses when given earlier versus later within the first year after HCT, supporting early SARS-CoV-2 mRNA (messenger RNA) vaccine initiation. “Our study team was happy to see that the mRNA SARS-CoV-2 vaccines appear to be as effective when administered at approximately three to four months after HCT compared to four to twelve months, which supports early vaccination to establish some degree of protection in this vulnerable patient population,” said Joshua Hill, MD, (Fred Hutchinson Cancer Center) who was the lead author of the study. “Nonetheless, vaccine responses remained lower than observed in non-immunocompromised patients, underscoring the need for other prevention and treatment strategies
“Vaccination continues to be important following hematopoietic stem cell transplantation (HCT) due to the higher risk of severe COVID-19 infection in these vulnerable patients. Yet, the optimal timing for SARS-CoV-2 mRNA vaccines within the first year after allogeneic HCT was poorly understood,” said Jeffery Auletta, MD, Senior Vice President, Patient Outcomes and Experience, NMDP/Be The Match, Chief Scientific Director, CIBMTR NMDP, and a co-author of the study. “Study results confirm recommendations from the Centers for Disease Prevention and Control for initiating SARS-CoV-2 vaccination early after allogeneic HCT. However, optimizing vaccination strategies is needed to ensure maximal protection in these immunocompromised patients.”
Current guidelines suggesting initiating the vaccine series as early as three months are based on historical experience with vaccines targeting other pathogens. None of these, however, have used the mRNA platform. To address this knowledge gap, CIBMTR, and BMT CTN conducted one of the largest prospective analyses ever of early vaccination for any pathogen after allogeneic HCT. The results show similar effectiveness in those vaccinated less than four months versus at or after four months post-treatment. More data is expected in the near future, but for now, COVID-19 vaccination within the first year of cellular therapy is still the standard clinical practice to ensure protection for this vulnerable population, even if the recipient is vaccinated before treatment.
“We are proud of our collaborative work with leaders in the cell therapy field, in both the public and private sectors, to advance cell therapies and clinical practices and to have the results shared widely in eClinicalMedicine,” Mary Horowitz, MD, MS, Scientific Director Emeritus, CIBMTR, Deputy Cancer Center Director at MCW, Principal Investigator for the Data and Coordinating Center of the BMT CTN and co-author of the study. “We are committed to continuing our research in this area to ensure that HCT patients have the best possible long-term outcomes, which includes protection from COVID-19.”
In addition to NMDP/Be The Match, this important study was sponsored in part by the Leukemia & Lymphoma Society, Adaptive Biotechnologies, American Society for Transplantation and Cellular Therapy, Fred Hutchinson Cancer Research Center, Labcorp, Leukemia & Lymphoma Society, Multiple Myeloma Research Foundation, The National Cancer Institute, The National Heart, Lung, and Blood Institute, and Novartis Pharmaceuticals Corporation.
The National Marrow Donor Program® (NMDP)/Be The Match® is the leading global partner working to save lives through cellular therapy. With 35 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, NMDP/Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy option—from blood stem cell transplant to a next-generation therapy—and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies®. NMDP/Be The Match is a tireless advocate for the cell therapy community, working with hematologists/oncologists to remove barriers to consultation and treatment, and supporting patients through no-cost programs to eliminate non-medical obstacles to cell therapy. In addition, they are a global leader in research through CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a collaboration with the Medical College of Wisconsin, investing in and managing research studies that improve patient outcomes and advance the future of care.
Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the National Marrow Donor Program (NMDP)/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. CIBMTR collaborates with the global scientific community to increase survival and enrich patient quality of life. CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 630,000 people who have received hematopoietic cell transplantation and other cellular therapies. Learn more at cibmtr.org.
The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies. The BMT CTN has completed accrual to >50 Phase II and III trials at more than 100 transplant centers and enrolled over 16,300 study participants. BMT CTN is funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both parts of the National Institutes of Health (NIH), and is a collaborative effort of 20 Core Transplant Centers/Consortia, The Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP)/Be The Match and the Emmes Company, LLC, a clinical research organization. CIBMTR is a research collaboration between the NMDP/Be The Match and the Medical College of Wisconsin. Together with MCW/CIBMTR and NMDP, Emmes has been providing research support to the BMT CTN since 2001, as a key member of the data coordinating center. More information about the BMT CTN can be found at www.bmtctn.net