No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study
Background: Several cases of unusual thrombotic events and thrombocytopenia were described after vaccination with recombinant adenoviral vectors encoding the spike protein antigen of SARS-CoV-2. Objectives: The objective of this study was to elucidate the impact of a COVID-19 heterologous vaccinatio...
| Autores: | , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Universidad Autónoma de Madrid |
| Repositorio: | Biblos-e Archivo. Repositorio Institucional de la UAM |
| Idioma: | inglés |
| OAI Identifier: | oai:repositorio.uam.es:10486/719637 |
| Acceso en línea: | http://hdl.handle.net/10486/719637 https://dx.doi.org/10.1016/j.rpth.2023.100049 |
| Access Level: | acceso abierto |
| Palabra clave: | anti-PF4 antibodies coagulation CombiVacS study COVID-19 vaccine hemostasis heterologous vaccination thrombocytopenia Medicina |
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| dc.title.none.fl_str_mv |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| title |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| spellingShingle |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study Butta, Nora V. anti-PF4 antibodies coagulation CombiVacS study COVID-19 vaccine hemostasis heterologous vaccination thrombocytopenia Medicina |
| title_short |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| title_full |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| title_fullStr |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| title_full_unstemmed |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| title_sort |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS study |
| dc.creator.none.fl_str_mv |
Butta, Nora V. Arias-Salgado, Elena G. Monzón Manzano, Elena Acuña, Paula Álvarez Roman, María Teresa Buño-Soto, Antonio Ramos Ramos, Juan Carlos Belda-Iniesta, Cristóbal Frías Iniesta, Jesús A. Carcas Sansuán, Antonio Javier Martínez de Soto, Lucía Miguel Buckley, Rosa de Lora, David García-Morales, María Teresa Borobia Pérez, Alberto M. Arribas López, José Ramón Jiménez Yuste, Víctor Manuel CombiVacS Study Group |
| author |
Butta, Nora V. |
| author_facet |
Butta, Nora V. Arias-Salgado, Elena G. Monzón Manzano, Elena Acuña, Paula Álvarez Roman, María Teresa Buño-Soto, Antonio Ramos Ramos, Juan Carlos Belda-Iniesta, Cristóbal Frías Iniesta, Jesús A. Carcas Sansuán, Antonio Javier Martínez de Soto, Lucía Miguel Buckley, Rosa de Lora, David García-Morales, María Teresa Borobia Pérez, Alberto M. Arribas López, José Ramón Jiménez Yuste, Víctor Manuel CombiVacS Study Group |
| author_role |
author |
| author2 |
Arias-Salgado, Elena G. Monzón Manzano, Elena Acuña, Paula Álvarez Roman, María Teresa Buño-Soto, Antonio Ramos Ramos, Juan Carlos Belda-Iniesta, Cristóbal Frías Iniesta, Jesús A. Carcas Sansuán, Antonio Javier Martínez de Soto, Lucía Miguel Buckley, Rosa de Lora, David García-Morales, María Teresa Borobia Pérez, Alberto M. Arribas López, José Ramón Jiménez Yuste, Víctor Manuel CombiVacS Study Group |
| author2_role |
author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Departamento de Farmacología Departamento de Medicina Facultad de Medicina |
| dc.subject.none.fl_str_mv |
anti-PF4 antibodies coagulation CombiVacS study COVID-19 vaccine hemostasis heterologous vaccination thrombocytopenia Medicina |
| topic |
anti-PF4 antibodies coagulation CombiVacS study COVID-19 vaccine hemostasis heterologous vaccination thrombocytopenia Medicina |
| description |
Background: Several cases of unusual thrombotic events and thrombocytopenia were described after vaccination with recombinant adenoviral vectors encoding the spike protein antigen of SARS-CoV-2. Objectives: The objective of this study was to elucidate the impact of a COVID-19 heterologous vaccination schedule, including priming with adenovirus vaccine, on hemostasis profiles. Methods: The present study is a subanalysis of the CombiVacS clinical trial initiated in April 2021 that included adult participants previously vaccinated with a single dose of ChAdOx1-S. Between 8 and 12 weeks after vaccination, they were randomly assigned (2:1) to receive either BNT162b2 vaccine (intervention group, n = 99) or continue observation (control group, n = 50). Samples drawn before and 28 days after a vaccination with BNT162b2 were analyzed for platelet count and markers of hemostasis (D-dimer, anti-PF4 antibodies, cfDNA, PAI-1, thrombin generation, and serum capacity to activate platelets). Results: Platelet count from all participants after receiving BNT162b2 was within the normal range. Anti-PF4 antibodies were present in 26% and 18% of the subjects from the control and intervention groups, respectively, at day 28. In most cases, the levels of anti-PF4 antibodies were high before receiving BNT162b2. Serum from these participants did not activate platelets from healthy controls. There were no differences between the groups in PAI-1 and cfDNA plasma levels. According to the D-dimer plasma concentration, the thrombin generation test showed that none of the participants had a procoagulant profile. Conclusion: Our data suggest that the heterologous vaccination against COVID-19 with ChAdOx1-S and a second dose with BNT162b2 might be safe in terms of haemostasis |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 2023-01-14 |
| dc.type.none.fl_str_mv |
research article http://purl.org/coar/resource_type/c_2df8fbb1 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
| format |
article |
| dc.identifier.none.fl_str_mv |
http://hdl.handle.net/10486/719637 https://dx.doi.org/10.1016/j.rpth.2023.100049 |
| url |
http://hdl.handle.net/10486/719637 https://dx.doi.org/10.1016/j.rpth.2023.100049 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| dc.rights.openaire.fl_str_mv |
info:eu-repo/semantics/openAccess |
| rights_invalid_str_mv |
open access http://purl.org/coar/access_right/c_abf2 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
| dc.format.none.fl_str_mv |
application/pdf |
| dc.publisher.none.fl_str_mv |
Elsevier |
| publisher.none.fl_str_mv |
Elsevier |
| dc.source.none.fl_str_mv |
reponame:Biblos-e Archivo. Repositorio Institucional de la UAM instname:Universidad Autónoma de Madrid |
| instname_str |
Universidad Autónoma de Madrid |
| reponame_str |
Biblos-e Archivo. Repositorio Institucional de la UAM |
| collection |
Biblos-e Archivo. Repositorio Institucional de la UAM |
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|
| repository.mail.fl_str_mv |
|
| _version_ |
1869415681712193536 |
| spelling |
No changes in hemostasis after COVID-19–heterologous vaccination schedule: A subanalysis of the phase 2 CombiVacS studyButta, Nora V.Arias-Salgado, Elena G.Monzón Manzano, ElenaAcuña, PaulaÁlvarez Roman, María TeresaBuño-Soto, AntonioRamos Ramos, Juan CarlosBelda-Iniesta, CristóbalFrías Iniesta, Jesús A.Carcas Sansuán, Antonio JavierMartínez de Soto, LucíaMiguel Buckley, Rosa deLora, DavidGarcía-Morales, María TeresaBorobia Pérez, Alberto M.Arribas López, José RamónJiménez Yuste, Víctor ManuelCombiVacS Study Groupanti-PF4 antibodiescoagulationCombiVacS studyCOVID-19 vaccinehemostasisheterologous vaccinationthrombocytopeniaMedicinaBackground: Several cases of unusual thrombotic events and thrombocytopenia were described after vaccination with recombinant adenoviral vectors encoding the spike protein antigen of SARS-CoV-2. Objectives: The objective of this study was to elucidate the impact of a COVID-19 heterologous vaccination schedule, including priming with adenovirus vaccine, on hemostasis profiles. Methods: The present study is a subanalysis of the CombiVacS clinical trial initiated in April 2021 that included adult participants previously vaccinated with a single dose of ChAdOx1-S. Between 8 and 12 weeks after vaccination, they were randomly assigned (2:1) to receive either BNT162b2 vaccine (intervention group, n = 99) or continue observation (control group, n = 50). Samples drawn before and 28 days after a vaccination with BNT162b2 were analyzed for platelet count and markers of hemostasis (D-dimer, anti-PF4 antibodies, cfDNA, PAI-1, thrombin generation, and serum capacity to activate platelets). Results: Platelet count from all participants after receiving BNT162b2 was within the normal range. Anti-PF4 antibodies were present in 26% and 18% of the subjects from the control and intervention groups, respectively, at day 28. In most cases, the levels of anti-PF4 antibodies were high before receiving BNT162b2. Serum from these participants did not activate platelets from healthy controls. There were no differences between the groups in PAI-1 and cfDNA plasma levels. According to the D-dimer plasma concentration, the thrombin generation test showed that none of the participants had a procoagulant profile. Conclusion: Our data suggest that the heterologous vaccination against COVID-19 with ChAdOx1-S and a second dose with BNT162b2 might be safe in terms of haemostasisThis work is funded by the Instituto de Salud Carlos III (ISCIII), a Spanish public body assigned to the Ministry of Science and Innovation that manages and promotes public clinical research related to public health. The Spanish Clinical Trials Platform (SCReN) is a public network of clinical trial units funded by the Instituto de Salud Carlos III (grant numbers PTC20/00018 and PT17/0017), the State Plan for Research, Development, and Innovation 2013–2016, the State Plan for Scientific and Technical Research and Innovation 2017–2020, and the Subdirectorate General for Evaluation and Promotion of Research, Instituto de Salud Carlos III, cofinanced with FEDER funds. CombiVacS was designed under the umbrella of the VACCELERATE (European Corona Vaccine Trial Accelerator Platform) project. A.M.B., A.J.C., and J.F. are members of the VACCELERATE Network, which aims to facilitate and accelerate the design and implementation of COVID-19 phase 2 and 3 vaccine trials. VACCELERATE received funding from the EU's Horizon 2020 Research and Innovation Programme (grant agreement numbers 101037867 and 860003). The Instituto de Salud Carlos III is the Spanish partner in the VACCELERATE projectElsevierDepartamento de FarmacologíaDepartamento de MedicinaFacultad de Medicina20232023-01-14research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10486/719637https://dx.doi.org/10.1016/j.rpth.2023.100049reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7196372026-06-23T12:46:27Z |
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15,812455 |