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

Sci Adv. 2025 Jun 27;11(26):eadq2887. doi: 10.1126/sciadv.adq2887. Epub 2025 Jun 27.

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.

Publication types

  • Clinical Trial, Phase III
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Neutralizing / blood
  • Antibodies, Neutralizing / immunology
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • CD8-Positive T-Lymphocytes / immunology
  • COVID-19 Vaccines* / administration & dosage
  • COVID-19 Vaccines* / adverse effects
  • COVID-19 Vaccines* / immunology
  • COVID-19* / immunology
  • COVID-19* / prevention & control
  • COVID-19* / virology
  • Double-Blind Method
  • Female
  • Humans
  • Immunization, Secondary
  • Immunogenicity, Vaccine*
  • Male
  • Middle Aged
  • SARS-CoV-2* / immunology
  • Spike Glycoprotein, Coronavirus / genetics
  • Spike Glycoprotein, Coronavirus / immunology
  • Young Adult

Substances

  • Antibodies, Neutralizing
  • COVID-19 Vaccines
  • Antibodies, Viral
  • Spike Glycoprotein, Coronavirus
  • spike protein, SARS-CoV-2