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Development and pre-clinical evaluation of Newcastle disease virus-vectored SARS-CoV-2 intranasal vaccine candidate

View ORCID ProfileManolo Fernandez Díaz, Katherine Calderon, Aldo Rojas-Neyra, Vikram N. Vakharia, Ricardo Choque-Guevara, Angela Montalvan, Astrid Poma-Acevedo, Dora Rios-Matos, Andres Agurto-Arteaga, María de Grecia Cauti-Mendoza, Norma Perez-Martinez, Gisela Isasi-Rivas, Luis Tataje-Lavanda, Miryam Palomino, Henri Bailón, Yacory Sernaque-Aguilar, Freddy Ygnacio-Aguirre, Manuel Criollo-Orozco, Edison Huaccachi-Gonzalez, Elmer Delgado-Ccancce, Doris Villanueva-Pérez, Ricardo Montesinos-Millan, Kristel Gutiérrez-Manchay, Katherine Pauyac-Antezana, Ingrid Ramirez-Ortiz, View ORCID ProfileStefany Quiñones-Garcia, View ORCID ProfileYudith Cauna-Orocollo, View ORCID ProfileKatherine Vallejos-Sánchez, View ORCID ProfileAngela A. Rios-Angulo, Dennis Núñez-Fernández, Mario I. Salguedo-Bohorquez, Julio Ticona, Manolo Fernández Sánchez, Paquita García, Eliana Icochea, Luis Guevara, View ORCID ProfileMirko Zimic, for the COVID-19 Working Group in Perú
doi: https://doi.org/10.1101/2021.03.07.434276
Manolo Fernandez Díaz
1Farmacológicos Veterinarios S.A.C. FARVET
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  • For correspondence: Farvet@farvet.com
Katherine Calderon
1Farmacológicos Veterinarios S.A.C. FARVET
2Universidad Nacional San Luis Gonzaga, Ica, Perú
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Aldo Rojas-Neyra
1Farmacológicos Veterinarios S.A.C. FARVET
2Universidad Nacional San Luis Gonzaga, Ica, Perú
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Vikram N. Vakharia
3Institute of Marine and Environmental Technology, University of Maryland Baltimore Country, Baltimore, USA
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Ricardo Choque-Guevara
1Farmacológicos Veterinarios S.A.C. FARVET
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Angela Montalvan
1Farmacológicos Veterinarios S.A.C. FARVET
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Astrid Poma-Acevedo
1Farmacológicos Veterinarios S.A.C. FARVET
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Dora Rios-Matos
1Farmacológicos Veterinarios S.A.C. FARVET
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Andres Agurto-Arteaga
1Farmacológicos Veterinarios S.A.C. FARVET
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María de Grecia Cauti-Mendoza
1Farmacológicos Veterinarios S.A.C. FARVET
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Norma Perez-Martinez
1Farmacológicos Veterinarios S.A.C. FARVET
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Gisela Isasi-Rivas
1Farmacológicos Veterinarios S.A.C. FARVET
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Luis Tataje-Lavanda
1Farmacológicos Veterinarios S.A.C. FARVET
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Miryam Palomino
4Instituto Nacional de Salud del Perú
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Henri Bailón
4Instituto Nacional de Salud del Perú
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Yacory Sernaque-Aguilar
1Farmacológicos Veterinarios S.A.C. FARVET
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Freddy Ygnacio-Aguirre
1Farmacológicos Veterinarios S.A.C. FARVET
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Manuel Criollo-Orozco
1Farmacológicos Veterinarios S.A.C. FARVET
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Edison Huaccachi-Gonzalez
1Farmacológicos Veterinarios S.A.C. FARVET
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Elmer Delgado-Ccancce
1Farmacológicos Veterinarios S.A.C. FARVET
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Doris Villanueva-Pérez
1Farmacológicos Veterinarios S.A.C. FARVET
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Ricardo Montesinos-Millan
1Farmacológicos Veterinarios S.A.C. FARVET
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Kristel Gutiérrez-Manchay
1Farmacológicos Veterinarios S.A.C. FARVET
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Katherine Pauyac-Antezana
1Farmacológicos Veterinarios S.A.C. FARVET
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Ingrid Ramirez-Ortiz
1Farmacológicos Veterinarios S.A.C. FARVET
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Stefany Quiñones-Garcia
1Farmacológicos Veterinarios S.A.C. FARVET
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  • ORCID record for Stefany Quiñones-Garcia
Yudith Cauna-Orocollo
1Farmacológicos Veterinarios S.A.C. FARVET
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Katherine Vallejos-Sánchez
1Farmacológicos Veterinarios S.A.C. FARVET
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  • ORCID record for Katherine Vallejos-Sánchez
Angela A. Rios-Angulo
1Farmacológicos Veterinarios S.A.C. FARVET
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  • ORCID record for Angela A. Rios-Angulo
Dennis Núñez-Fernández
1Farmacológicos Veterinarios S.A.C. FARVET
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Mario I. Salguedo-Bohorquez
1Farmacológicos Veterinarios S.A.C. FARVET
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Julio Ticona
1Farmacológicos Veterinarios S.A.C. FARVET
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Manolo Fernández Sánchez
1Farmacológicos Veterinarios S.A.C. FARVET
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Paquita García
4Instituto Nacional de Salud del Perú
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Eliana Icochea
1Farmacológicos Veterinarios S.A.C. FARVET
5Laboratorio de Patología Aviar. Facultad de Medicina Veterinaria. Universidad Nacional Mayor de San Marcos, Lima, Perú
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Luis Guevara
1Farmacológicos Veterinarios S.A.C. FARVET
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Mirko Zimic
1Farmacológicos Veterinarios S.A.C. FARVET
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  • ORCID record for Mirko Zimic
1Farmacológicos Veterinarios S.A.C. FARVET
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ABSTRACT

The COVID-19 pandemic has claimed the lives of millions of people worldwide and threatens to become an endemic problem, therefore the need for as many types of vaccines as possible is of high importance.

Because of the millions of doses required, it is desirable that vaccines are not only safe and effective, but also easy to administer, store, and inexpensive to produce.

Newcastle Disease Virus (NDV) is responsible for a respiratory disease in chickens. It has no pathogenic homologue in humans. NDV is recognized as an oncolytic virus, and its use in humans for oncological treatment is being evaluated.

In the present work, we have developed two types of NDV-vectored candidate vaccines, which carry the surface-exposed RBD and S1 antigens of SARS-CoV-2, respectively. These vaccine candidates were produced in specific-pathogen-free embryonating chicken eggs, and purified from allantoic fluid before lyophilization. These vaccines were administered intranasally to three different animal models: mice, rats and hamsters, and evaluated for safety, toxicity, immunogenicity, stability and efficacy. Efficacy was evaluated in a challenge assay against active SARS-CoV-2 virus in the Golden Syrian hamster model.

The NDV-vectored vaccine based on the S1 antigen was shown to be safe and highly immunogenic, with the ability to neutralize SARS-CoV-2 in-vitro, even with an extreme dilution of 1/640. Our results reveal that this vaccine candidate protects the lungs of the animals, preventing cellular damage in this tissue. In addition, this vaccine reduces the viral load in the lungs, suggesting that it may significantly reduce the likelihood of transmission. Being lyophilized, this vaccine candidate is very stable and can be stored for several months at 4-8⁰C.

In conclusion, our NDV-based vaccine candidate has shown a very favorable performance in the pre-clinical study, serving as evidence for a future evaluation in a Phase-I human clinical trial. This candidate represents a promising tool in the fight against COVID-19.

Competing Interest Statement

The authors have declared no competing interest.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.
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Posted March 10, 2021.
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Development and pre-clinical evaluation of Newcastle disease virus-vectored SARS-CoV-2 intranasal vaccine candidate
Manolo Fernandez Díaz, Katherine Calderon, Aldo Rojas-Neyra, Vikram N. Vakharia, Ricardo Choque-Guevara, Angela Montalvan, Astrid Poma-Acevedo, Dora Rios-Matos, Andres Agurto-Arteaga, María de Grecia Cauti-Mendoza, Norma Perez-Martinez, Gisela Isasi-Rivas, Luis Tataje-Lavanda, Miryam Palomino, Henri Bailón, Yacory Sernaque-Aguilar, Freddy Ygnacio-Aguirre, Manuel Criollo-Orozco, Edison Huaccachi-Gonzalez, Elmer Delgado-Ccancce, Doris Villanueva-Pérez, Ricardo Montesinos-Millan, Kristel Gutiérrez-Manchay, Katherine Pauyac-Antezana, Ingrid Ramirez-Ortiz, Stefany Quiñones-Garcia, Yudith Cauna-Orocollo, Katherine Vallejos-Sánchez, Angela A. Rios-Angulo, Dennis Núñez-Fernández, Mario I. Salguedo-Bohorquez, Julio Ticona, Manolo Fernández Sánchez, Paquita García, Eliana Icochea, Luis Guevara, Mirko Zimic, for the COVID-19 Working Group in Perú
bioRxiv 2021.03.07.434276; doi: https://doi.org/10.1101/2021.03.07.434276
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Development and pre-clinical evaluation of Newcastle disease virus-vectored SARS-CoV-2 intranasal vaccine candidate
Manolo Fernandez Díaz, Katherine Calderon, Aldo Rojas-Neyra, Vikram N. Vakharia, Ricardo Choque-Guevara, Angela Montalvan, Astrid Poma-Acevedo, Dora Rios-Matos, Andres Agurto-Arteaga, María de Grecia Cauti-Mendoza, Norma Perez-Martinez, Gisela Isasi-Rivas, Luis Tataje-Lavanda, Miryam Palomino, Henri Bailón, Yacory Sernaque-Aguilar, Freddy Ygnacio-Aguirre, Manuel Criollo-Orozco, Edison Huaccachi-Gonzalez, Elmer Delgado-Ccancce, Doris Villanueva-Pérez, Ricardo Montesinos-Millan, Kristel Gutiérrez-Manchay, Katherine Pauyac-Antezana, Ingrid Ramirez-Ortiz, Stefany Quiñones-Garcia, Yudith Cauna-Orocollo, Katherine Vallejos-Sánchez, Angela A. Rios-Angulo, Dennis Núñez-Fernández, Mario I. Salguedo-Bohorquez, Julio Ticona, Manolo Fernández Sánchez, Paquita García, Eliana Icochea, Luis Guevara, Mirko Zimic, for the COVID-19 Working Group in Perú
bioRxiv 2021.03.07.434276; doi: https://doi.org/10.1101/2021.03.07.434276

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