SK bioscience announced on January 29 that it has initiated a global Phase 1/2 clinical trial in Australia for GBP511, a vaccine candidate designed to target the sarbecovirus subgenus of coronaviruses.
Sarbecoviruses include SARS-CoV-2, the virus responsible for COVID-19, as well as related SARS-like coronaviruses found in animals that may pose a future spillover risk to humans. SK bioscience said GBP511 is intended to serve as a universal vaccine capable of inducing broad immune responses across the sarbecovirus family, rather than targeting individual variants.
The Phase 1/2 trial will enroll approximately 368 adults aged 18 years and older in Australia. In Phase 1, participants will receive two doses administered 28 days apart across low-, medium-, and high-dose cohorts, with or without an adjuvant. The study will evaluate safety, tolerability, and immunogenicity, with comparisons made against Comirnaty as a comparator.
Based on Phase 1 results, the optimal dose and regimen will be selected for Phase 2, which will further assess safety and immunogenicity in both adult and elderly populations. The trial will also evaluate cross-reactive immune responses across the sarbecovirus family, including SARS-CoV-2, to determine GBP511’s potential as a universal coronavirus vaccine.
GBP511 incorporates core technologies developed for SKYCovione, which in 2022 became the only domestically developed COVID-19 vaccine in South Korea to achieve commercialization. Building on SKYCovione’s computer-designed antigen platform, GBP511 combines SK bioscience’s recombinant protein technology with self-assembling nanoparticle design technology developed by the Institute for Protein Design at the University of Washington School of Medicine. SKYCovione previously demonstrated strong immunogenicity and a favorable safety profile in global clinical trials, forming the basis for regulatory approvals in multiple regions.
While a number of pharmaceutical companies and research institutions worldwide are pursuing universal coronavirus vaccines, most programs remain at the preclinical or early research stage. SK bioscience’s GBP511 is among the first broadly protective coronavirus vaccines to advance into global Phase 1/2 clinical development.
The Coalition for Epidemic Preparedness Innovations (CEPI) has designated the SARS coronavirus family as a prototype pathogen, citing the high likelihood that future pandemics could emerge repeatedly from the same viral group. CEPI has emphasized the limitations of variant-specific vaccine strategies and has called for the development of broadly protective coronavirus vaccines capable of addressing novel threats, including viruses within the broader betacoronavirus family such as SARS and MERS.
Academic journals including Nature Reviews Immunology and The Lancet Microbe have also highlighted the potential role of universal sarbecovirus vaccines as a key component of future pandemic preparedness, citing their ability to provide broad cross-neutralizing activity and durable immune protection.
Against this backdrop, the global COVID-19 vaccine market is expected to transition from short-term, outbreak-driven demand to more sustained mid- and long-term growth. According to Coherent Market Insights, the global COVID-19 vaccine market is estimated at approximately USD 50.6 billion in 2025 and is projected to grow at a compound annual growth rate of 7.4 percent through 2032, reaching about USD 83.4 billion. Next-generation technologies, including universal vaccines, are expected to drive new sources of demand.
Richard Hatchett, CEO of CEPI, said the COVID-19 pandemic underscored the risks of facing emerging viral threats without effective vaccines. He added that the progression of SK bioscience’s broadly protective coronavirus vaccine into Phase 1/2 trials represents a significant step toward strengthening global pandemic preparedness and highlights South Korea’s role in advanced vaccine innovation.
Jaeyong Ahn, CEO of SK bioscience, said developing a universal sarbecovirus vaccine is a critical task in preparing for future pandemics, noting that the launch of the GBP511 clinical trial marks an effort to accelerate universal vaccine development and expand the company’s global role in infectious disease preparedness.
SK bioscience is also advancing other vaccine programs, including a 21-valent pneumococcal conjugate vaccine and an avian influenza vaccine, as part of its strategy to expand its infectious disease portfolio and strengthen long-term global health readiness.
