Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine

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.

Authors

Institutions

Publication Details

Journal
Science Advances
Published
2025-06-27
DOI
https://doi.org/10.1126/sciadv.adq2887
Citations
2
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
2.79
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine

Bernardo Lozano-Dubernard, Weina Sun, Peter Palese, Adolfo Garcı́a-Sastre et al.
2 citations
Science Advances
SARS-CoV-2 and COVID-19 Research
2.79
article

Phase 2/3 study evaluating safety, immunogenicity, and noninferiority of single booster dose of AVX/COVID-12 vaccine

Bernardo Lozano-Dubernard, Weina Sun, Peter Palese, Adolfo Garcı́a-Sastre, Edgar Cervantes-Trujano, Héctor Elías Chagoya-Cortés, Horacio Zamudio‐Meza, Georgina Paz-De la Rosa, David Sarfati-Mizrahi, Oscar Rojas-Martínez, Niels H. Wacher, Mercedes Viettri, Alejandro José Muñiz-Carvajal, Constantino López-Macı́as, Felipa Castro-Peralta, Martha Torres, Gustavo Peralta-Sánchez, Dámaris P. Romero‐Rodríguez, Fernando Lozano-Patiño, Luis Del Carpio-Orantes, Luis Ramírez-Martínez, Arturo Galindo‐Fraga, Esmeralda Juárez, Florian Krammer, Tania Rivera-Hernández, Andrea Alicia Colli-Domínguez, Francisco Márquez-Díaz, Laura E. Carreto-Binaghi, Jesus Abraham Simón Campos, Alejandro Suárez-Martínez, Andrea Palencia, Brenda Armenta-Copca, Laura Castro-Castrezana, Alejandro Torres-Flores, Juan José Rivera-Alcocer, Efrén Alberto Sánchez-Campos, Rafael Aguirre-Rivero, Isabel Erika Rucker-Joerg, Claudia Carranza
article en
2 citations

Abstract

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.

Science AdvancesVol. 11(26)
Mexican Social Security Institute (MX), Instituto Tecnológico de Mérida (MX), Autonomous University of Aguascalientes (MX), Autonomous University of Yucatán (MX), Kohler (New Zealand) (NZ), Mexican Geological Survey (MX), Centro de Investigación Docencia y Consultoria Administrativa (CO), Universidad Chapultepec (MX), Centro Universitario del Pacífico Sur (MX), Universidad Interamericana para el Desarrollo (MX), Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (MX), Instituto Nacional de Enfermedades Respiratorias (MX), Secretaría de Investigación, Innovación y Educación Superior (MX), Centro Medico Nacional Siglo XXI (MX), Autonomous University of Yucatán (MX), Instituto Nacional de Salud Pública (MX), Centro Médico ABC (MX), Hospital de Especialidades (MX), Universidad Tecnológica de Aguascalientes (MX), Universidad Politécnica de Aguascalientes (MX), Secretaría de Ciencia, Humanidades, Tecnología e Innovación (MX), Pemex (Mexico) (MX), Instituto Politécnico Nacional (MX), Medical University of Vienna (AT), Icahn School of Medicine at Mount Sinai (US)
No poverty
Openalex Percentile: Top 10%
SARS-CoV-2 and COVID-19 Research
2.79
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.