Researchers from Korea conducted a clinical trial to assess the immunogenicity and safety of GBP510/AS03 relative to the ChAdOx1-S vaccine.
The interim results show that GBP510/AS03 had an acceptable safety profile and induced stronger antibody responses when compared with ChAdOx1-S
GBP510 is a recombinant vaccine adjuvanted with AS03, designed to target the SARS-CoV-2 virus’s spike receptor-binding domains.
The team of researchers, led by Professor Hee Jin Cheong and Joon Young Song from the Korea University College of Medicine in Seoul, conducted a randomised, active-controlled, observer-blinded, parallel group, Phase III study across six countries.
“In the prevailing context where mRNA vaccines have taken the centre stage, we examined the outcomes of a preceding Phase I/II study, that demonstrated the high immunogenicity of the adjuvanted nanoparticle-based vaccine platform GBP510/AS03. This led us to embark on the current study,” said Professor Cheong.
The participants were split in two groups: those with no prior SARS-CoV-2 infection or Covid-19 vaccination history and those irrespective of these parameters. Each participant received two injections of either GBP510/AS03 or ChAdOx1-S. The researchers found that the immune response induced by two doses of GBP510/AS03 was superior to that induced by ChAdOx1-S.
The higher neutralising antibodies with GBP510/AS03 were seen in participants regardless of age, sex, or ethnicity. Regarding safety assessment, GBP510/AS03 demonstrated a clinically acceptable safety profile, and no safety concerns were identified throughout the study period.
“The incorporation of an adjuvant into the nanoparticle-based vaccine platform has showcased both a robust ability to enhance the immune response and safety in this extensive Phase III clinical trial. This development opens up the potential for broad future applications, not only in the creation of new infectious disease vaccines but also in the enhancement of existing vaccines to elevate their safety and efficacy,” said Professor Song.
