tetano
Editor, Senior Moderator
Sci Adv
. 2025 Jun 27;11(26):eadq2887.
doi: 10.1126/sciadv.adq2887. Epub 2025 Jun 27. Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine
Constantino López-Macías[SUP] 1 [/SUP], Martha Torres[SUP] 2 [/SUP], Brenda Armenta-Copca[SUP] 3 [/SUP], Niels H Wacher[SUP] 4 [/SUP], Arturo Galindo-Fraga[SUP] 5 [/SUP], Laura Castro-Castrezana[SUP] 6 [/SUP], Andrea Alicia Colli-Domínguez[SUP] 7 [/SUP], Edgar Cervantes-Trujano[SUP] 8 [/SUP], Isabel Erika Rucker-Joerg[SUP] 9 [/SUP], Fernando Lozano-Patiño[SUP] 10 [/SUP], Juan José Rivera-Alcocer[SUP] 11 [/SUP], Abraham Simón-Campos[SUP] 12 [/SUP], Efrén Alberto Sánchez-Campos[SUP] 13 [/SUP], Rafael Aguirre-Rivero[SUP] 14 [/SUP], Alejandro José Muñiz-Carvajal[SUP] 15 [/SUP], Luis Del Carpio-Orantes[SUP] 16 [/SUP], Francisco Márquez-Díaz[SUP] 17 [/SUP], Tania Rivera-Hernández[SUP] 1 18 [/SUP], Alejandro Torres-Flores[SUP] 1 19 [/SUP], Luis Ramírez-Martínez[SUP] 20 [/SUP], Georgina Paz-De la Rosa[SUP] 20 [/SUP], Oscar Rojas-Martínez[SUP] 20 [/SUP], Alejandro Suárez-Martínez[SUP] 20 [/SUP], Gustavo Peralta-Sánchez[SUP] 20 [/SUP], Claudia Carranza[SUP] 2 [/SUP], Esmeralda Juárez[SUP] 21 [/SUP], Horacio Zamudio-Meza[SUP] 2 [/SUP], Laura E Carreto-Binaghi[SUP] 2 [/SUP], Mercedes Viettri[SUP] 2 [/SUP], Damaris Romero-Rodríguez[SUP] 22 [/SUP], Andrea Palencia[SUP] 2 [/SUP], David Sarfati-Mizrahi[SUP] 20 [/SUP], Weina Sun[SUP] 23 [/SUP], Héctor Elías Chagoya-Cortés[SUP] 24 [/SUP], Felipa Castro-Peralta[SUP] 20 [/SUP], Peter Palese[SUP] 23 [/SUP], Florian Krammer[SUP] 23 25 26 27 [/SUP], Adolfo García-Sastre[SUP] 23 26 28 29 30 31 [/SUP], Bernardo Lozano-Dubernard[SUP] 20 [/SUP]
Affiliations
Low- and middle-income countries face substantial challenges in immunizing against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including high costs, limited access, and insufficient local manufacturing. To address these issues, we developed and locally manufactured the AVX/COVID-12 vaccine using a cost-effective Newcastle disease virus LaSota platform to express a stabilized SARS-CoV-2 spike protein (HexaPro-S). We evaluated the AVX/COVID-12 vaccine in a phase 2/3 parallel-group, double-blind, active-controlled, noninferiority trial with 4056 volunteers, demonstrating its safety, good tolerability, and ability to induce neutralizing antibodies against ancestral SARS-CoV-2 and the Omicron BA.2 and BA.5 variants. It also stimulated interferon-γ-producing CD8[SUP]+[/SUP] T cells and met the World Health Organization's noninferiority criteria compared to AZ/ChAdOx-1-S. No vaccinated participants experienced severe disease, hospitalization, or death. These findings support the use of AVX/COVID-12 as a booster to help achieve and maintain population immunity while addressing global inequities in vaccine distribution, and it has been approved for adult booster use in Mexico.
. 2025 Jun 27;11(26):eadq2887.
doi: 10.1126/sciadv.adq2887. Epub 2025 Jun 27. Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine
Constantino López-Macías[SUP] 1 [/SUP], Martha Torres[SUP] 2 [/SUP], Brenda Armenta-Copca[SUP] 3 [/SUP], Niels H Wacher[SUP] 4 [/SUP], Arturo Galindo-Fraga[SUP] 5 [/SUP], Laura Castro-Castrezana[SUP] 6 [/SUP], Andrea Alicia Colli-Domínguez[SUP] 7 [/SUP], Edgar Cervantes-Trujano[SUP] 8 [/SUP], Isabel Erika Rucker-Joerg[SUP] 9 [/SUP], Fernando Lozano-Patiño[SUP] 10 [/SUP], Juan José Rivera-Alcocer[SUP] 11 [/SUP], Abraham Simón-Campos[SUP] 12 [/SUP], Efrén Alberto Sánchez-Campos[SUP] 13 [/SUP], Rafael Aguirre-Rivero[SUP] 14 [/SUP], Alejandro José Muñiz-Carvajal[SUP] 15 [/SUP], Luis Del Carpio-Orantes[SUP] 16 [/SUP], Francisco Márquez-Díaz[SUP] 17 [/SUP], Tania Rivera-Hernández[SUP] 1 18 [/SUP], Alejandro Torres-Flores[SUP] 1 19 [/SUP], Luis Ramírez-Martínez[SUP] 20 [/SUP], Georgina Paz-De la Rosa[SUP] 20 [/SUP], Oscar Rojas-Martínez[SUP] 20 [/SUP], Alejandro Suárez-Martínez[SUP] 20 [/SUP], Gustavo Peralta-Sánchez[SUP] 20 [/SUP], Claudia Carranza[SUP] 2 [/SUP], Esmeralda Juárez[SUP] 21 [/SUP], Horacio Zamudio-Meza[SUP] 2 [/SUP], Laura E Carreto-Binaghi[SUP] 2 [/SUP], Mercedes Viettri[SUP] 2 [/SUP], Damaris Romero-Rodríguez[SUP] 22 [/SUP], Andrea Palencia[SUP] 2 [/SUP], David Sarfati-Mizrahi[SUP] 20 [/SUP], Weina Sun[SUP] 23 [/SUP], Héctor Elías Chagoya-Cortés[SUP] 24 [/SUP], Felipa Castro-Peralta[SUP] 20 [/SUP], Peter Palese[SUP] 23 [/SUP], Florian Krammer[SUP] 23 25 26 27 [/SUP], Adolfo García-Sastre[SUP] 23 26 28 29 30 31 [/SUP], Bernardo Lozano-Dubernard[SUP] 20 [/SUP]
Affiliations
- PMID: 40577471
- PMCID: PMC12204155
- DOI: 10.1126/sciadv.adq2887
Low- and middle-income countries face substantial challenges in immunizing against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including high costs, limited access, and insufficient local manufacturing. To address these issues, we developed and locally manufactured the AVX/COVID-12 vaccine using a cost-effective Newcastle disease virus LaSota platform to express a stabilized SARS-CoV-2 spike protein (HexaPro-S). We evaluated the AVX/COVID-12 vaccine in a phase 2/3 parallel-group, double-blind, active-controlled, noninferiority trial with 4056 volunteers, demonstrating its safety, good tolerability, and ability to induce neutralizing antibodies against ancestral SARS-CoV-2 and the Omicron BA.2 and BA.5 variants. It also stimulated interferon-γ-producing CD8[SUP]+[/SUP] T cells and met the World Health Organization's noninferiority criteria compared to AZ/ChAdOx-1-S. No vaccinated participants experienced severe disease, hospitalization, or death. These findings support the use of AVX/COVID-12 as a booster to help achieve and maintain population immunity while addressing global inequities in vaccine distribution, and it has been approved for adult booster use in Mexico.