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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.
Rojas-Jiménez, Gabriel; Solano, Daniela; Segura, Álvaro; Sánchez, Andrés; Chaves-Araya, Stephanie; Herrera, María; Vargas, Mariángela; Cerdas, Maykel; Calvo, Gerardo; Alfaro, Jonathan; Molina, Sebastián; Bolaños, Kimberly; Moreira-Soto, Andrés; Villalta, Mauren; Sánchez, Adriana; Cordero, Daniel; Durán, Gina; Solano, Gabriela; Gómez, Aarón; Hernández, Andrés; Sánchez, Laura; Vargas, Marco; Drexler, Jean Felix; Alape-Girón, Alberto; Díaz, Cecilia; León, Guillermo.
  • Rojas-Jiménez G; Sección de Virología Médica, Departamento de Microbiología e Inmunología, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Solano D; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Segura Á; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Sánchez A; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Chaves-Araya S; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Herrera M; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Vargas M; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Cerdas M; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Calvo G; Laboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa Rica.
  • Alfaro J; Laboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa Rica.
  • Molina S; Banco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social, San José, Costa Rica.
  • Bolaños K; Banco Nacional de Sangre, Gerencia Médica, Caja Costarricense del Seguro Social, San José, Costa Rica.
  • Moreira-Soto A; Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Villalta M; Centro de Investigación en Enfermedades Tropicales (CIET), Facultad de Microbiología, Universidad de Costa Rica, San Jose, Costa Rica.
  • Sánchez A; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Cordero D; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Durán G; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Solano G; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Gómez A; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Hernández A; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Sánchez L; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Vargas M; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
  • Drexler JF; Laboratorio Clínico y Banco de Sangre de la Universidad de Costa Rica, Oficina de Bienestar y Salud, Universidad de Costa Rica, San José, Costa Rica.
  • Alape-Girón A; Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Díaz C; German Centre for Infection Research (DZIF), Associated Partner Charité-Universitätsmedizin Berlin, Berlin, Germany.
  • León G; Instituto Clodomiro Picado, Factulad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
Front Med Technol ; 3: 772275, 2021.
Article in English | MEDLINE | ID: covidwho-1637014
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Language: English Journal: Front Med Technol Year: 2021 Document Type: Article Affiliation country: Fmedt.2021.772275

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study Topics: Vaccines Language: English Journal: Front Med Technol Year: 2021 Document Type: Article Affiliation country: Fmedt.2021.772275