Cargando…

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

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 af...

Descripción completa

Detalles Bibliográficos
Autores principales: Ram, Ron, Hagin, David, Kikozashvilli, Nino, Freund, Tal, Amit, Odelia, Bar-On, Yael, Beyar-Katz, Ofrat, Shefer, Gabi, Moshiashvili, Miguel Morales, Karni, Chen, Gold, Ronit, Kay, Sigi, Glait-Santar, Chen, Eshel, Rinat, Perry, Chava, Avivi, Irit, Apel, Arie, Benyamini, Noam, Shasha, David, Ben-Ami, Ronen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242200/
https://www.ncbi.nlm.nih.gov/pubmed/34214738
http://dx.doi.org/10.1016/j.jtct.2021.06.024
_version_ 1783715581308960768
author Ram, Ron
Hagin, David
Kikozashvilli, Nino
Freund, Tal
Amit, Odelia
Bar-On, Yael
Beyar-Katz, Ofrat
Shefer, Gabi
Moshiashvili, Miguel Morales
Karni, Chen
Gold, Ronit
Kay, Sigi
Glait-Santar, Chen
Eshel, Rinat
Perry, Chava
Avivi, Irit
Apel, Arie
Benyamini, Noam
Shasha, David
Ben-Ami, Ronen
author_facet Ram, Ron
Hagin, David
Kikozashvilli, Nino
Freund, Tal
Amit, Odelia
Bar-On, Yael
Beyar-Katz, Ofrat
Shefer, Gabi
Moshiashvili, Miguel Morales
Karni, Chen
Gold, Ronit
Kay, Sigi
Glait-Santar, Chen
Eshel, Rinat
Perry, Chava
Avivi, Irit
Apel, Arie
Benyamini, Noam
Shasha, David
Ben-Ami, Ronen
author_sort Ram, Ron
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8242200
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc.
record_format MEDLINE/PubMed
spelling pubmed-82422002021-07-01 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 Ram, Ron Hagin, David Kikozashvilli, Nino Freund, Tal Amit, Odelia Bar-On, Yael Beyar-Katz, Ofrat Shefer, Gabi Moshiashvili, Miguel Morales Karni, Chen Gold, Ronit Kay, Sigi Glait-Santar, Chen Eshel, Rinat Perry, Chava Avivi, Irit Apel, Arie Benyamini, Noam Shasha, David Ben-Ami, Ronen Transplant Cell Ther Full Length Article 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. The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. 2021-09 2021-06-30 /pmc/articles/PMC8242200/ /pubmed/34214738 http://dx.doi.org/10.1016/j.jtct.2021.06.024 Text en © 2021 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Full Length Article
Ram, Ron
Hagin, David
Kikozashvilli, Nino
Freund, Tal
Amit, Odelia
Bar-On, Yael
Beyar-Katz, Ofrat
Shefer, Gabi
Moshiashvili, Miguel Morales
Karni, Chen
Gold, Ronit
Kay, Sigi
Glait-Santar, Chen
Eshel, Rinat
Perry, Chava
Avivi, Irit
Apel, Arie
Benyamini, Noam
Shasha, David
Ben-Ami, Ronen
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Full Length Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8242200/
https://www.ncbi.nlm.nih.gov/pubmed/34214738
http://dx.doi.org/10.1016/j.jtct.2021.06.024
work_keys_str_mv AT ramron safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT hagindavid safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT kikozashvillinino safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT freundtal safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT amitodelia safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT baronyael safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT beyarkatzofrat safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT shefergabi safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT moshiashvilimiguelmorales safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT karnichen safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT goldronit safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT kaysigi safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT glaitsantarchen safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT eshelrinat safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT perrychava safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT aviviirit safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT apelarie safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT benyamininoam safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT shashadavid safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy
AT benamironen safetyandimmunogenicityofthebnt162b2mrnacovid19vaccineinpatientsafterallogeneichctorcd19basedcarttherapyasinglecenterprospectivecohortstudy