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


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Authors: Rojas Jiménez, Gabriel, Solano Centeno, Daniela, Segura Ruiz, Álvaro, Sánchez Brenes, Andrés, Chaves Araya, Stephanie, Herrera Vega, María, Vargas Arroyo, Mariángela, Cerdas Solís, Maykel, Calvo Salas, Gerardo, Alfaro Alvarado, Jonathan A., Bolaños Céspedes, Kimberly, Moreira Soto, Andrés, Villalta Arrieta, Mauren, Sánchez Sánchez, Adriana, Cordero Vásquez, Daniel, Durán Blanco, Gina, Solano Blanco, María Gabriela, Gómez Argüello, Aarón, Hernández Bolaños, Andrés, Sánchez Céspedes, Laura Vanessa, Vargas Soto, Marco, Drexler, Jan Felix, Alape Girón, Alberto, Díaz Oreiro, Cecilia, León Montero, Guillermo
Format: artículo original
Publication Date:2022
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 Rojas-Jiménez et al. Anti-SARS-CoV-2 IVIg 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.
Institution:Universidad de Costa Rica
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Access Level:acceso abierto
Keyword:BNT162b2 vaccine
Convalescent plasma
Hyperimmune plasma
Hyperimmune polyclonal antibodies
Passive immunotherapy