Por favor, use este identificador para citar o enlazar este ítem: 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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