Interim safety and immunogenicity results from an NDV-based COVID-19 vaccine phase I trial in Mexico.

Autor: Ponce-de-León S; Programa Universitario de Investigación en Salud (PUIS), Facultad de Medicina, Universidad Nacional Autónoma de México (UNAM), Edif. de los Programas Universitarios, Planta Alta. Circuito de la Investigación Científica S/N Ciudad Universitaria, Ciudad de México, C.P. 04510, México., Torres M; Laboratorio de Inmunobiología de la tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER), Ismael Cossio Villegas, Calzada de Tlalpan 4502, Sección XVI, CP 14080, Tlalpan, México., Soto-Ramírez LE; Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición 'Salvador Zubirán', Vasco de Quiroga 15, Belisario Dominguez, Sección XVI, 14080, Tlalpan, México.; Departamento de Infectología y Vigilancia Epidemiológica, Hospital Médica Sur, S.A.B. de C. V., Puente de Piedra 150, Toriello Guerra, 14050, Tlalpan, México., Calva JJ; Department of Infectious Diseases, Instituto Nacional de Ciencias Médicas y Nutrición 'Salvador Zubirán', Vasco de Quiroga 15, Belisario Dominguez, Sección XVI, 14080, Tlalpan, México., Santillán-Doherty P; Instituto Nacional de Enfermedades Respiratorias (INER), Ismael Cossio Villegas, Calzada de Tlalpan 4502, Sección XVI, CP 14080, Tlalpan, México., Carranza-Salazar DE; ProcliniQ Investigación Clínica, S. A. de C. V., Renato Leduc 155 (Xontepec 91), Toriello Guerra, 14050, Tlalpan, México., Carreño JM; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., Carranza C; Laboratorio de Inmunobiología de la tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER), Ismael Cossio Villegas, Calzada de Tlalpan 4502, Sección XVI, CP 14080, Tlalpan, México., Juárez E; Departamento de Investigación en Microbiología, Instituto Nacional de Enfermedades Respiratorias (INER), Ismael Cossio Villegas, Calzada de Tlalpan 4502, Sección XVI, CP 14080, Tlalpan, México., Carreto-Binaghi LE; Laboratorio de Inmunobiología de la tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER), Ismael Cossio Villegas, Calzada de Tlalpan 4502, Sección XVI, CP 14080, Tlalpan, México., Ramírez-Martínez L; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Paz De la Rosa G; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Vigueras-Moreno R; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Ortiz-Stern A; iLS Clinical Research, S. C. (iLS), Matias Romero 102 - 205 Del Valle, Benito Juárez, CP 03100, CDMX, México., López-Vidal Y; Programa de Inmunología Molecular Microbiana, Departamento de Microbiología y Parasitología, Facultad de Medicina, Universidad Nacional Autónoma de México (UNAM), Av. Universidad 3000, Circuito Interior S/N. Ciudad Universitaria, Coyoacán, CP.04510, México., Macías AE; Departamento de Medicina, Universidad de Guanajuato, 20 de Enero 929, C.P 37000, León Guanajuato, México., Torres-Flores J; Dirección Adjunta de Desarrollo Tecnológico, Vinculación e Innovación, Consejo Nacional de Ciencia y Tecnología (CONACYT), Insurgentes Sur 1582, Crédito Constructor, CP 03940, Benito Juárez, CDMX, México., Rojas-Martínez O; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Suárez-Martínez A; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Peralta-Sánchez G; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Kawabata H; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., González-Domínguez I; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., Martínez-Guevara JL; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., Sun W; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., Sarfati-Mizrahi D; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Soto-Priante E; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Chagoya-Cortés HE; Consultora Mextrategy, S.A.S. de C. V. (Mextrategy), Insurgentes Sur 1079 P7-127, Nochebuena, CP 03720, CDMX, Mexico., López-Macías C; Unidad de Investigación Médica en Inmunoquímica. Hospital de Especialidades del Centro Médico Nacional Siglo XXI. Instituto Mexicano del Seguro Social (IMSS), Av. Cuauhtémoc 330, Doctores, C.P. 06720, Benito Juárez, CDMX, México., Castro-Peralta F; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico., Palese P; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.; Department of Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA., García-Sastre A; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. adolfo.garcia-sastre@mssm.edu.; Department of Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. adolfo.garcia-sastre@mssm.edu.; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. adolfo.garcia-sastre@mssm.edu.; The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. adolfo.garcia-sastre@mssm.edu.; Department of Pathology, Molecular and Cell-based Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. adolfo.garcia-sastre@mssm.edu., Krammer F; Department of Microbiology, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. florian.krammer@mssm.edu.; Department of Pathology, Molecular and Cell-based Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA. florian.krammer@mssm.edu., Lozano-Dubernard B; Laboratorio Avi-Mex, S. A. de C. V. (Avimex), Maíz 18, Granjas Esmeralda, CP 09810, Iztapalapa, CDMX, Mexico. lozano@avimex.com.mx.
Jazyk: angličtina
Zdroj: NPJ vaccines [NPJ Vaccines] 2023 May 10; Vol. 8 (1), pp. 67. Date of Electronic Publication: 2023 May 10.
DOI: 10.1038/s41541-023-00662-6
Abstrakt: 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 a 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
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