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
Fecha
2022
Tipo
artículo original
Autores
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.
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Resumen
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.
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Palabras clave
BNT162b2 vaccine, Convalescent plasma, COVID-19, Hyperimmune plasma, Hyperimmune polyclonal antibodies, IVIg, Passive immunotherapy, SARS-CoV-2