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

被引：6

作者：

Rojas-Jimenez, Gabriel ^{[1
]}

Solano, Daniela ^{[2
]}

Segura, Alvaro ^{[2
]}

Sanchez, Andres ^{[2
]}

Chaves-Araya, Stephanie ^{[2
]}

Herrera, Maria ^{[2
]}

Vargas, Mariangela ^{[2
]}

Cerdas, Maykel ^{[2
]}

Calvo, Gerardo ^{[3
,4
]}

Alfaro, Jonathan ^{[3
,4
]}

Molina, Sebastian ^{[5
]}

Bolanos, Kimberly ^{[5
]}

Moreira-Soto, Andres ^{[6
,7
,8
,9
,10
]}

Villalta, Mauren ^{[2
]}

Sanchez, Adriana ^{[2
]}

Cordero, Daniel ^{[2
]}

Duran, Gina ^{[2
]}

Solano, Gabriela ^{[2
]}

Gomez, Aaron ^{[2
]}

Hernandez, Andres ^{[2
]}

Sanchez, Laura ^{[2
]}

Vargas, Marco ^{[3
,4
]}

Drexler, Jean Felix ^{[6
,7
,8
,9
,11
]}

Alape-Giron, Alberto ^{[2
,12
]}

Diaz, Cecilia ^{[2
,12
]}

Leon, Guillermo ^{[2
]}

机构：

[1] Univ Costa Rica, Fac Microbiol, Dept Microbiol & Inmunol, Secc Virol Med, San Jose, Costa Rica

[2] Univ Costa Rica, Inst Clodomiro Picado, Fac Microbiol, San Jose, Costa Rica

[3] Univ Costa Rica, Lab Clin, Oficina Bienestar & Salud, San Jose, Costa Rica

[4] Univ Costa Rica, Banco Sangre, Oficina Bienestar & Salud, San Jose, Costa Rica

[5] Banco Nacl Sangre, Gerencia Med, Caja Costarricense Seguro Social, San Jose, Costa Rica

[6] Charite Univ Med Berlin, Inst Virol, Berlin, Germany

[7] Free Univ Berlin, Berlin, Germany

[8] Humboldt Univ, Berlin, Germany

[9] Berlin Inst Hlth, Berlin, Germany

[10] Univ Costa Rica, Fac Microbiol, Ctr Invest Enfermedades Trop CIET, San Jose, Costa Rica

[11] Charite Univ Med Berlin, German Ctr Infect Res DZIF, Berlin, Germany

[12] Univ Costa Rica, Escuela Med, Dept Bioquim, San Jose, Costa Rica

来源：

FRONTIERS IN MEDICAL TECHNOLOGY | 2022年 / 3卷

关键词：

BNT162b2; vaccine; convalescent plasma; COVID-19; hyperimmune plasma; hyperimmune polyclonal antibodies; IVIg; passive immunotherapy; SARS-CoV-2; IGG;

D O I：

10.3389/fmedt.2021.772275

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

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.

引用

页数：9

共 35 条

[1] Clinical effectiveness of convalescent plasma in hospitalized patients with COVID-19: a systematic review and meta-analysis [J].

Abeldano Zuniga, Roberto Ariel ;

Gonzalez-Villoria, Ruth Ana Maria ;

Elizondo, Maria Vanesa ;

Osorio, Anel Yaneli Nicolas ;

Martinez, David Gomez ;

Coca, Silvia Mercedes .

THERAPEUTIC ADVANCES IN RESPIRATORY DISEASE, 2021, 15

[2] Hyperimmune anti-COVID-19 IVIG (C-IVIG) treatment in severe and critical COVID-19 patients: A phase I/II randomized control trial [J].

Ali, Shaukat ;

Uddin, Syed Muneeb ;

Shalim, Elisha ;

Sayeed, Muneeba Ahsan ;

Anjum, Fatima ;

Saleem, Farah ;

Muhaymin, Sheikh Muhammad ;

Ali, Ayesha ;

Ali, Mir Rashid ;

Ahmed, Iqra ;

Mushtaq, Tehreem ;

Khan, Sadaf ;

Shahab, Faisal ;

Luxmi, Shobha ;

Kumar, Suneel ;

Arain, Habiba ;

Khan, Mujtaba ;

Khan, Abdul Samad ;

Mehmood, Hamid ;

Rasheed, Abdur ;

Jahangeer, Ashraf ;

Baig, SaifUllah ;

Quraishy, Saeed .

ECLINICALMEDICINE, 2021, 36

[3] Production of hyperimmune anti-SARS-CoV-2 intravenous immunoglobulin from pooled COVID-19 convalescent plasma [J].

Ali, Shaukat ;

Uddin, Syed M. ;

Ali, Ayesha ;

Anjum, Fatima ;

Ali, Rashid ;

Shalim, Elisha ;

Khan, Mujtaba ;

Ahmed, Iqra ;

M Muhaymin, Sheikh ;

Bukhari, Uzma ;

Luxmi, Shobha ;

Khan, Abdul S. ;

Quraishy, Saeed .

IMMUNOTHERAPY, 2021, 13 (05) :397-407

[4] Convalescent plasma and hyperimmune globulin therapy in COVID-19 [J].

Cagdas, Deniz .

EXPERT REVIEW OF CLINICAL IMMUNOLOGY, 2021, 17 (04) :309-315

[5] The Principles of Antibody Therapy for Infectious Diseases with Relevance for COVID-19 [J].

Casadevall, Arturo ;

Pirofski, Liise-Anne ;

Joyner, Michael J. .

MBIO, 2021, 12 (02) :1-13

[6] COVID-19 and Hyperimmune sera: A feasible plan B to fight against coronavirus [J].

da Costa, Camila B. P. ;

Martins, Francislene J. ;

da Cunha, Luis E. R. ;

Ratcliffe, Norman A. ;

de Paula, Rafael Cisne ;

Castro, Helena C. .

INTERNATIONAL IMMUNOPHARMACOLOGY, 2021, 90

[7] Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19 [J].

Doria-Rose, Nicole ;

Suthar, Mehul S. ;

Makowski, Mat .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (23) :2259-2261

[8] Minipool Caprylic Acid Fractionation of Plasma Using Disposable Equipment: A Practical Method to Enhance Immunoglobulin Supply in Developing Countries [J].

El-Ekiaby, Magdy ;

Vargas, Mariangela ;

Sayed, Makram ;

Gorgy, George ;

Goubran, Hadi ;

Radosevic, Mirjana ;

Burnouf, Thierry .

PLOS NEGLECTED TROPICAL DISEASES, 2015, 9 (02)

[9] Supply and delivery of vaccines for global health [J].

Excler, Jean-Louis ;

Privor-Dumm, Lois ;

Kim, Jerome H. .

CURRENT OPINION IN IMMUNOLOGY, 2021, 71 :13-20

[10] Seroprevalence of anti-SARS-CoV-2 antibodies in COVID-19 patients and healthy volunteers up to 6 months post disease onset [J].

Figueiredo-Campos, Patricia ;

Blankenhaus, Birte ;

Mota, Catarina ;

Gomes, Andreia ;

Serrano, Marta ;

Ariotti, Silvia ;

Costa, Catarina ;

Nunes-Cabaco, Helena ;

Mendes, Antonio M. ;

Gaspar, Pedro ;

Pereira-Santos, M. Conceicao ;

Rodrigues, Fabiana ;

Condeco, Jorge ;

Escoval, M. Antonia ;

Santos, Matilde ;

Ramirez, Mario ;

Melo-Cristino, Jose ;

Simas, J. Pedro ;

Vasconcelos, Eugenia ;

Afonso, Angela ;

Veldhoen, Marc .

EUROPEAN JOURNAL OF IMMUNOLOGY, 2020, 50 (12) :2025-2040

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