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http://conacyt.repositorioinstitucional.mx/jspui/handle/1000/7692| 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 | |
| SAMUEL PONCE DE LEON ROSALES MARTHA TORRES ROJAS LUIS ENRIQUE SOTO RAMIREZ JUAN JOSE CALVA MERCADO patricio santillan_doherty Dora Eugenia Carranza Salazar JUAN MANUEL CARREÑO QUIROZ CLAUDIA CARRANZA SALAZAR ESMERALDA JUAREZ CARVAJAL LAURA ELENA CARRETO BINAGHI LUIS RAMIREZ MARTINEZ GEORGINA PAZ DE LA ROSA ROSALIA VIGUERAS MORENO ALEJANDRO ORTIZ STERN YOLANDA LOPEZ VIDAL ALEJANDRO E. MACIAS JESUS MIGUEL TORRES FLORES OSCAR ROJAS MARTINEZ JESUS ALEJANDRO SUAREZ MARTINEZ GUSTAVO PERALTA SANCHEZ HISAAKI KAWABATA IRENE GONZALEZ DOMINGUEZ JOSE LUIS MARTINEZ GUEVARA Weina Sun DAVID SARFATI MIZRAHI ERNESTO SOTO PRIANTE HECTOR ELIAS CHAGOYA CORTES CONSTANTINO LOPEZ MACIAS FELIPA CASTRO PERALTA Peter Palese ADOLFO GARCIA SASTRE Florian Krammer BERNARDO LOZANO DUBERNARD | |
| Acceso Abierto | |
| Atribución-NoComercial-SinDerivadas | |
| https://doi.org/10.1101/2022.02.08.22270676 | |
| https://www.medrxiv.org/content/10.1101/2022.02.08.22270676v1 | |
| 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. | |
| medRxiv and bioRxiv | |
| 09-02-2022 | |
| Preimpreso | |
| https://www.medrxiv.org/ | |
| Inglés | |
| Epidemia COVID-19 | |
| Público en general | |
| VIRUS RESPIRATORIOS | |
| Versión publicada | |
| publishedVersion - Versión publicada | |
| Aparece en las colecciones: | Artículos científicos |
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| Safety and immunogenicity of a live recombinant newcastle desease virus based COVID 19.pdf | 2.5 MB | Adobe PDF | Visualizar/Abrir |