1. Safety and Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Patients after Allogeneic HCT or CD19-based CART therapy—A Single-Center Prospective Cohort Study
- Author
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Nino Kikozashvilli, Irit Avivi, Ronen Ben-Ami, Chava Perry, Miguel Morales Moshiashvili, David Hagin, Chen Glait-Santar, Gabi Shefer, David Shasha, Noam Benyamini, Odelia Amit, Arie Apel, Sigi Kay, Rinat Eshel, Tal Freund, Ron Ram, Yael Bar-On, Ofrat Beyar-Katz, Chen Karni, and Ronit Gold
- Subjects
Oncology ,medicine.medical_specialty ,COVID-19 Vaccines ,medicine.medical_treatment ,Hematopoietic stem cell transplantation ,Article ,Cell therapy ,immune system diseases ,Internal medicine ,Humans ,CART ,Immunology and Allergy ,Medicine ,Prospective Studies ,RNA, Messenger ,Adverse effect ,BNT162 Vaccine ,Transplantation ,Cytopenia ,SARS-CoV-2 ,business.industry ,Immunogenicity ,ELISPOT ,Hematopoietic Stem Cell Transplantation ,COVID-19 ,Cell Biology ,Hematology ,vaccination ,medicine.disease ,Vaccination ,HCT ,Molecular Medicine ,Female ,business - Abstract
Data are scarce regarding both the safety and immunogenicity of the BNT162b2 mRNA COVID-19 vaccine in patients undergoing immune cell therapy; thus, we prospectively evaluated these two domains in patients receiving this vaccine after allogeneic hematopoietic cell transplantation (HCT; n = 66) or after CD19-based chimeric antigen receptor T cell (CART) therapy (n = 14). Overall, the vaccine was well tolerated, with mild non-hematologic vaccine-reported adverse events in a minority of the patients. Twelve percent of the patients after the first dose and 10% of the patients after the second dose developed cytopenia, and there were three cases of graft-versus-host disease exacerbation after each dose. A single case of impending graft rejection was summarized as possibly related. Evaluation of immunogenicity showed that 57% of patients after CART infusion and 75% patients after allogeneic HCT had evidence of humoral and/or cellular response to the vaccine. The Cox regression model indicated that longer time from infusion of cells, female sex, and higher CD19+ cells were associated with a positive humoral response, whereas a higher CD4+/CD8+ ratio was correlated with a positive cellular response, as confirmed by the ELISpot test. We conclude that the BNT162b2 mRNA COVID-19 vaccine has impressive immunogenicity in patients after allogeneic HCT or CART. Adverse events were mostly mild and transient, but some significant hematologic events were observed; hence, patients should be closely monitored.
- Published
- 2021
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