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Publications

Clinical Trial, Phase II Clinical Trial, Phase III Equivalence Trial Journal Article Randomized Controlled Trial Ppublish

PubMed: 40577471 DOI: 10.1126/sciadv.adq2887

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

Sci Adv 11(26):eadq2887

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

Affiliations

  • Unidad de Investigación Médica en Inmunoquímica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México (CDMX), México.
  • Laboratorio de Inmunobiología de la Tuberculosis, Instituto Nacional de Enfermedades Respiratorias (INER) "Ismael Cosío Villegas," CDMX, México.
  • iLS Clinical Research S.C. CDMX, México.
  • Unidad de Investigación Médica en Epidemiología Clínica, UMAE Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, CDMX, México.
  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), CDMX, México.
  • CAIMED Investigación en Salud S.A. de C.V. CDMX, México.
  • Oaxaca Site Management Organization (OSMO) S.C. Oaxaca, México.
  • Centro de Investigación Clínica Acelerada (CICA) S.C. CDMX, México.
  • Clinical Research Institute (CRI) S.C. Edo. de México, Tlalnepantla, México.
  • Centro de Investigación Clínica Chapultepec, CDMX, México.
  • Unidad de Atención Médica e Investigación en Salud (UNAMIS), Mérida, Yucatán, México.
  • Köhler & Milstein Research (K&M) Facultad de Medicina, Universidad Autónoma de Yucatán, Mérida, Yucatán, México.
  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigación Clínica en Yucatán (CEMDEICY) S.C. Mérida, Yucatán, México.
  • Centro de Investigación Clínica del Pacifico (CICPA), Acapulco, Guerrero, México.
  • Red OSMO, Centro de Investigación y Avances Médicos Especializados (CIAME), Cancún, Quintana Roo, México.
  • Instituto Veracruzano de Investigación Clínica (IVIC) S.C. Veracruz, México.
  • Hospital de Cardiología de Aguascalientes, Aguascalientes, México.
  • Investigadores por México, Consejo Nacional de Humanidades, Ciencias y Tecnologías (CONAHCYT), CDMX, México.
  • Posgrado en Inmunología, Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, CDMX, México.
  • Laboratorio Avi-Mex S.A. de C.V. CDMX, México.
  • Departamento de Investigación en Microbiología, INER "Ismael Cosío Villegas," CDMX, México.
  • Unidad de Citometría, INER "Ismael Cosío Villegas," CDMX, México.
  • Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Consultora Mextrategy S.A.S. de C.V. CDMX, México.
  • Center for Vaccine Research and Pandemic Preparedness (C-VaRPP), Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Department of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Ignaz Semmelweis Institute, Interuniversity Institute for Infection Research, Medical University of Vienna, Vienna, Austria.
  • Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
  • The Icahn Genomics Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

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 + 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.

MeSH

Sars-Cov-2, Safety, Vaccines, Biological Science Disciplines, Viruses