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Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico
There is still a need for safe, efficient and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that express...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cold Spring Harbor Laboratory
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8845421/ https://www.ncbi.nlm.nih.gov/pubmed/35169806 http://dx.doi.org/10.1101/2022.02.08.22270676 |
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author | Ponce-de-León, Samuel Torres, Martha Soto-Ramírez, Luis Enrique Calva, Juan José Santillán-Doherty, Patricio Carranza-Salazar, Dora Eugenia Carreño, Juan Manuel Carranza, Claudia Juárez, Esmeralda Carreto-Binaghi, Laura E. Ramírez-Martínez, Luis Paz-De la Rosa, Georgina Vigueras-Moreno, Rosalía Ortiz-Stern, Alejandro López-Vidal, Yolanda Macías, Alejandro E. Torres-Flores, Jesús Rojas-Martínez, Oscar Suárez-Martínez, Alejandro Peralta-Sánchez, Gustavo Kawabata, Hisaaki González-Domínguez, Irene Martínez-Guevara, José Luis Sun, Weina Sarfati-Mizrahi, David Soto-Priante, Ernesto Chagoya-Cortés, Héctor Elías López-Macías, Constantino Castro-Peralta, Felipa Palese, Peter García-Sastre, Adolfo Krammer, Florian Lozano-Dubernard, Bernardo |
author_facet | Ponce-de-León, Samuel Torres, Martha Soto-Ramírez, Luis Enrique Calva, Juan José Santillán-Doherty, Patricio Carranza-Salazar, Dora Eugenia Carreño, Juan Manuel Carranza, Claudia Juárez, Esmeralda Carreto-Binaghi, Laura E. Ramírez-Martínez, Luis Paz-De la Rosa, Georgina Vigueras-Moreno, Rosalía Ortiz-Stern, Alejandro López-Vidal, Yolanda Macías, Alejandro E. Torres-Flores, Jesús Rojas-Martínez, Oscar Suárez-Martínez, Alejandro Peralta-Sánchez, Gustavo Kawabata, Hisaaki González-Domínguez, Irene Martínez-Guevara, José Luis Sun, Weina Sarfati-Mizrahi, David Soto-Priante, Ernesto Chagoya-Cortés, Héctor Elías López-Macías, Constantino Castro-Peralta, Felipa Palese, Peter García-Sastre, Adolfo Krammer, Florian Lozano-Dubernard, Bernardo |
author_sort | Ponce-de-León, Samuel |
collection | PubMed |
description | There is still a need for safe, efficient and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at low cost similar to influenza virus vaccines and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737. Funding was provided by Avimex and CONACYT. |
format | Online Article Text |
id | pubmed-8845421 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Cold Spring Harbor Laboratory |
record_format | MEDLINE/PubMed |
spelling | pubmed-88454212022-02-16 Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico Ponce-de-León, Samuel Torres, Martha Soto-Ramírez, Luis Enrique Calva, Juan José Santillán-Doherty, Patricio Carranza-Salazar, Dora Eugenia Carreño, Juan Manuel Carranza, Claudia Juárez, Esmeralda Carreto-Binaghi, Laura E. Ramírez-Martínez, Luis Paz-De la Rosa, Georgina Vigueras-Moreno, Rosalía Ortiz-Stern, Alejandro López-Vidal, Yolanda Macías, Alejandro E. Torres-Flores, Jesús Rojas-Martínez, Oscar Suárez-Martínez, Alejandro Peralta-Sánchez, Gustavo Kawabata, Hisaaki González-Domínguez, Irene Martínez-Guevara, José Luis Sun, Weina Sarfati-Mizrahi, David Soto-Priante, Ernesto Chagoya-Cortés, Héctor Elías López-Macías, Constantino Castro-Peralta, Felipa Palese, Peter García-Sastre, Adolfo Krammer, Florian Lozano-Dubernard, Bernardo medRxiv Article There is still a need for safe, efficient and low-cost coronavirus disease 2019 (COVID-19) vaccines that can stop transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we evaluated a vaccine candidate based on a live recombinant Newcastle disease virus (NDV) that expresses a stable version of the spike protein in infected cells as well as on the surface of the viral particle (AVX/COVID-12-HEXAPRO, also known as NDV-HXP-S). This vaccine candidate can be grown in embryonated eggs at low cost similar to influenza virus vaccines and it can also be administered intranasally, potentially to induce mucosal immunity. We evaluated this vaccine candidate in prime-boost regimens via intramuscular, intranasal, or intranasal followed by intramuscular routes in an open label non-randomized non-placebo-controlled phase I clinical trial in Mexico in 91 volunteers. The primary objective of the trial was to assess vaccine safety and the secondary objective was to determine the immunogenicity of the different vaccine regimens. In the interim analysis reported here, the vaccine was found to be safe and the higher doses tested were found to be immunogenic when given intramuscularly or intranasally followed by intramuscular administration, providing the basis for further clinical development of the vaccine candidate. The study is registered under ClinicalTrials.gov identifier NCT04871737. Funding was provided by Avimex and CONACYT. Cold Spring Harbor Laboratory 2022-02-09 /pmc/articles/PMC8845421/ /pubmed/35169806 http://dx.doi.org/10.1101/2022.02.08.22270676 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which allows reusers to copy and distribute the material in any medium or format in unadapted form only, for noncommercial purposes only, and only so long as attribution is given to the creator. |
spellingShingle | Article Ponce-de-León, Samuel Torres, Martha Soto-Ramírez, Luis Enrique Calva, Juan José Santillán-Doherty, Patricio Carranza-Salazar, Dora Eugenia Carreño, Juan Manuel Carranza, Claudia Juárez, Esmeralda Carreto-Binaghi, Laura E. Ramírez-Martínez, Luis Paz-De la Rosa, Georgina Vigueras-Moreno, Rosalía Ortiz-Stern, Alejandro López-Vidal, Yolanda Macías, Alejandro E. Torres-Flores, Jesús Rojas-Martínez, Oscar Suárez-Martínez, Alejandro Peralta-Sánchez, Gustavo Kawabata, Hisaaki González-Domínguez, Irene Martínez-Guevara, José Luis Sun, Weina Sarfati-Mizrahi, David Soto-Priante, Ernesto Chagoya-Cortés, Héctor Elías López-Macías, Constantino Castro-Peralta, Felipa Palese, Peter García-Sastre, Adolfo Krammer, Florian Lozano-Dubernard, Bernardo Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title | Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title_full | Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title_fullStr | Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title_full_unstemmed | Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title_short | Safety and immunogenicity of a live recombinant Newcastle disease virus-based COVID-19 vaccine (Patria) administered via the intramuscular or intranasal route: Interim results of a non-randomized open label phase I trial in Mexico |
title_sort | safety and immunogenicity of a live recombinant newcastle disease virus-based covid-19 vaccine (patria) administered via the intramuscular or intranasal route: interim results of a non-randomized open label phase i trial in mexico |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8845421/ https://www.ncbi.nlm.nih.gov/pubmed/35169806 http://dx.doi.org/10.1101/2022.02.08.22270676 |
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