Safety and Immunogenicity of a Newcastle Disease Virus Vector-Based SARS-CoV-2 Vaccine Candidate, AVX/COVID-12-HEXAPRO (Patria), in Pigs.

Autor:	Lara-Puente JH; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Carreño JM; Department of Microbiology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., Sun W; Department of Microbiology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., Suárez-Martínez A; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Ramírez-Martínez L; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Quezada-Monroy F; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Paz-De la Rosa G; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Vigueras-Moreno R; Diagnósticos Clínicos Veterinarios, S. A. de C. V. (DCV), Iztapalapa, CDMX, Mexico., Singh G; Department of Microbiology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., Rojas-Martínez O; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Chagoya-Cortés HE; Consultora Mextrategy, S. A. S. de C. V., Benito Juárez, CDMX, Mexico., Sarfati-Mizrahi D; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Soto-Priante E; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., López-Macías C; Unidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI. Instituto Mexicano del Seguro Social (IMSS), Cuauhtémoc, CDMX, Mexico., Krammer F; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA.; Department of Pathology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., Castro-Peralta F; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico., Palese P; Department of Microbiology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA.; Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., García-Sastre A; Department of Microbiology, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA.; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA.; Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA.; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinaigrid.59734.3c, New York, New York, USA., Lozano-Dubernard B; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Iztapalapa, CDMX, Mexico.
Jazyk:	angličtina
Zdroj:	MBio [mBio] 2021 Oct 26; Vol. 12 (5), pp. e0190821. Date of Electronic Publication: 2021 Sep 21.
DOI:	10.1128/mBio.01908-21
Abstrakt:	Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were developed in record time and show excellent efficacy and effectiveness against coronavirus disease 2019 (COVID-19). However, currently approved vaccines cannot meet the global demand. In addition, none of the currently used vaccines is administered intranasally to potentially induce mucosal immunity. Here, we tested the safety and immunogenicity of a second-generation SARS-CoV-2 vaccine that includes a stabilized spike antigen and can be administered intranasally. The vaccine is based on a live Newcastle disease virus vector expressing a SARS-CoV-2 spike protein stabilized in a prefusion conformation with six beneficial proline substitutions (AVX/COVID-12-HEXAPRO; Patria). Immunogenicity testing in the pig model showed that both intranasal and intramuscular application of the vaccine as well as a combination of the two induced strong serum neutralizing antibody responses. Furthermore, substantial reactivity to B.1.1.7, B.1.351, and P.1 spike variants was detected. Finally, no adverse reactions were found in the experimental animals at any dose level or delivery route. These results indicate that the experimental vaccine AVX/COVID-12-HEXAPRO (Patria) is safe and highly immunogenic in the pig model. IMPORTANCE Several highly efficacious vaccines for SARS-CoV-2 have been developed and are used in the population. However, the current production capacity cannot meet the global demand. Therefore, additional vaccines-especially ones that can be produced locally and at low cost-are urgently needed. This work describes preclinical testing of a SARS-CoV-2 vaccine candidate which meets these criteria.
Databáze:	MEDLINE
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