In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors
Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins coul...
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Frontiers Media S.A.
2022-01-01
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmedt.2021.772275/full |
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| author | Gabriel Rojas-Jiménez Daniela Solano Álvaro Segura Andrés Sánchez Stephanie Chaves-Araya María Herrera Mariángela Vargas Maykel Cerdas Gerardo Calvo Jonathan Alfaro Sebastián Molina Kimberly Bolaños Andrés Moreira-Soto Andrés Moreira-Soto Mauren Villalta Adriana Sánchez Daniel Cordero Gina Durán Gabriela Solano Aarón Gómez Andrés Hernández Laura Sánchez Marco Vargas Jean Felix Drexler Jean Felix Drexler Alberto Alape-Girón Alberto Alape-Girón Cecilia Díaz Cecilia Díaz Guillermo León |
| author_facet | Gabriel Rojas-Jiménez Daniela Solano Álvaro Segura Andrés Sánchez Stephanie Chaves-Araya María Herrera Mariángela Vargas Maykel Cerdas Gerardo Calvo Jonathan Alfaro Sebastián Molina Kimberly Bolaños Andrés Moreira-Soto Andrés Moreira-Soto Mauren Villalta Adriana Sánchez Daniel Cordero Gina Durán Gabriela Solano Aarón Gómez Andrés Hernández Laura Sánchez Marco Vargas Jean Felix Drexler Jean Felix Drexler Alberto Alape-Girón Alberto Alape-Girón Cecilia Díaz Cecilia Díaz Guillermo León |
| author_sort | Gabriel Rojas-Jiménez |
| collection | DOAJ |
| description | Despite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries. |
| first_indexed | 2024-04-11T20:37:01Z |
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| spelling | doaj.art-620da11d36514b7a8744aa3d300ded3b2022-12-22T04:04:20ZengFrontiers Media S.A.Frontiers in Medical Technology2673-31292022-01-01310.3389/fmedt.2021.772275772275In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent DonorsGabriel Rojas-Jiménez0Daniela Solano1Álvaro Segura2Andrés Sánchez3Stephanie Chaves-Araya4María Herrera5Mariángela Vargas6Maykel Cerdas7Gerardo Calvo8Jonathan Alfaro9Sebastián Molina10Kimberly Bolaños11Andrés Moreira-Soto12Andrés Moreira-Soto13Mauren Villalta14Adriana Sánchez15Daniel Cordero16Gina Durán17Gabriela Solano18Aarón Gómez19Andrés Hernández20Laura Sánchez21Marco Vargas22Jean Felix Drexler23Jean Felix Drexler24Alberto Alape-Girón25Alberto Alape-Girón26Cecilia Díaz27Cecilia Díaz28Guillermo León29Sección de Virología Médica, Departamento de Microbiología e Inmunología, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaLaboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa RicaLaboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa RicaBanco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social, San José, Costa RicaBanco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social, San José, Costa RicaInstitute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, GermanyCentro de Investigación en Enfermedades Tropicales (CIET), Facultad de Microbiología, Universidad de Costa Rica, San Jose, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaLaboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa RicaInstitute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, GermanyGerman Centre for Infection Research (DZIF), Associated Partner Charité-Universitätsmedizin Berlin, Berlin, GermanyInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaDepartamento de Bioquímica, Escuela de Medicina, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaDepartamento de Bioquímica, Escuela de Medicina, Universidad de Costa Rica, San José, Costa RicaInstituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa RicaDespite vaccines are the main strategy to control the ongoing global COVID-19 pandemic, their effectiveness could not be enough for individuals with immunosuppression. In these cases, as well as in patients with moderate/severe COVID-19, passive immunization with anti-SARS-CoV-2 immunoglobulins could be a therapeutic alternative. We used caprylic acid precipitation to prepare a pilot-scale batch of anti-SARS-CoV-2 intravenous immunoglobulins (IVIg) from plasma of donors immunized with the BNT162b2 (Pfizer-BioNTech) anti-COVID-19 vaccine (VP-IVIg) and compared their in vitro efficacy and safety with those of a similar formulation produced from plasma of COVID-19 convalescent donors (CP-IVIg). Both formulations showed immunological, physicochemical, biochemical, and microbiological characteristics that meet the specifications of IVIg formulations. Moreover, the concentration of anti-RBD and ACE2-RBD neutralizing antibodies was higher in VP-IVIg than in CP-IVIg. In concordance, plaque reduction neutralization tests showed inhibitory concentrations of 0.03–0.09 g/L in VP-IVIg and of 0.06–0.13 in CP-IVIg. Thus, VP-IVIg has in vitro efficacy and safety profiles that justify their evaluation as therapeutic alternative for clinical cases of COVID-19. Precipitation with caprylic acid could be a simple, feasible, and affordable alternative to produce formulations of anti-SARS-CoV-2 IVIg to be used therapeutically or prophylactically to confront the COVID-19 pandemic in middle and low-income countries.https://www.frontiersin.org/articles/10.3389/fmedt.2021.772275/fullBNT162b2 vaccineconvalescent plasmaCOVID-19hyperimmune plasmahyperimmune polyclonal antibodiesIVIg |
| spellingShingle | Gabriel Rojas-Jiménez Daniela Solano Álvaro Segura Andrés Sánchez Stephanie Chaves-Araya María Herrera Mariángela Vargas Maykel Cerdas Gerardo Calvo Jonathan Alfaro Sebastián Molina Kimberly Bolaños Andrés Moreira-Soto Andrés Moreira-Soto Mauren Villalta Adriana Sánchez Daniel Cordero Gina Durán Gabriela Solano Aarón Gómez Andrés Hernández Laura Sánchez Marco Vargas Jean Felix Drexler Jean Felix Drexler Alberto Alape-Girón Alberto Alape-Girón Cecilia Díaz Cecilia Díaz Guillermo León In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors Frontiers in Medical Technology BNT162b2 vaccine convalescent plasma COVID-19 hyperimmune plasma hyperimmune polyclonal antibodies IVIg |
| title | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
| title_full | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
| title_fullStr | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
| title_full_unstemmed | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
| title_short | In vitro Characterization of Anti-SARS-CoV-2 Intravenous Immunoglobulins (IVIg) Produced From Plasma of Donors Immunized With the BNT162b2 Vaccine and Its Comparison With a Similar Formulation Produced From Plasma of COVID-19 Convalescent Donors |
| title_sort | in vitro characterization of anti sars cov 2 intravenous immunoglobulins ivig produced from plasma of donors immunized with the bnt162b2 vaccine and its comparison with a similar formulation produced from plasma of covid 19 convalescent donors |
| topic | BNT162b2 vaccine convalescent plasma COVID-19 hyperimmune plasma hyperimmune polyclonal antibodies IVIg |
| url | https://www.frontiersin.org/articles/10.3389/fmedt.2021.772275/full |
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