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A recent Phase 1 multicentre trial evaluated the COVAC-2 booster vaccine for safety and immunogenicity. This recombinant protein subunit vaccine contains the SARS-CoV-2 S1 protein. Specifically, researchers combined it with Sepivac SWE™, an open-access oil-in-water adjuvant, to enhance the immune response. The study investigated its performance as a heterologous booster in healthy adults.
The trial enrolled 60 participants who received 10 µg, 25 µg, or a placebo. Consequently, the results indicated that the 25 µg dose elicited the most significant humoral and cellular responses. Notably, peak antibody titers appeared 14 days after vaccination. These levels remained sustained through Day 180. Furthermore, flow cytometry revealed elevated IFN-γ and IL-2 levels. These markers clearly indicate strong antigen-specific T-cell activation. In addition, the team observed minimal IL-4 and IL-13 responses. Because of this, the vaccine likely promotes a favorable Th1-biased immunity.
Likewise, participants tolerated the vaccine well throughout the study period. Researchers categorized most adverse events as mild or moderate. Significantly, they attributed no serious adverse events to the vaccination. Moreover, the formulation demonstrates excellent thermal stability. Therefore, this platform offers a scalable solution for global vaccination strategies. This is especially relevant for countries where cold-chain logistics are difficult. Ultimately, COVAC-2 represents a promising and accessible tool for enhancing long-term protection against COVID-19.
The study demonstrated that the 25 µg dose provided the most robust humoral and cellular immune responses compared to the lower 10 µg dose.
Yes, the trial reported that COVAC-2 was well tolerated. Most participants only experienced mild or moderate adverse events, with no serious safety concerns identified.
Disclaimer: This content is for informational and educational purposes only. It is not intended as medical advice or a substitute for professional clinical judgment. Refer to the latest local and national guidelines for clinical practice.
References
Hamonic G et al. Safety and immunogenicity of a booster dose of COVAC-2, a Sepivac SWE™ adjuvanted SARS-CoV-2 recombinant protein vaccine in previously vaccinated healthy adults; a randomized controlled multicentre trial. Hum Vaccin Immunother. 2026 Dec undefined. doi: 10.1080/21645515.2026.2683765. PMID: 42268674.
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This Phase 1 trial evaluated the COVAC-2 recombinant protein vaccine as a heterologous booster. Results show that the 25 µg dose induces robust humoral and cellular immunity and is well tolerated. Its thermal stability makes it an excellent candidate for global vaccination programs.
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