Phase I Trial Shows First AI-Designed pEVAC-PS Vaccine Safe in 39 Adults

The University of Southampton, Cambridge, and DIOSynVax team used computational simulations to engineer a super-antigen targeting the receptor-binding domain across SARS-CoV-1, SARS-CoV-2, and related betacoronaviruses. Thirty-nine healthy adults aged 18-50 who had prior COVID-19 vaccination received two doses at 0.2-1.2 mg via PharmaJet Tropis device between December 2021 and September 2023. No serious adverse events occurred; local reactions remained mild and did not increase with dose.

Immune readouts showed limited boosting of RBD-specific antibodies, consistent with phase I focus on safety rather than efficacy. This approach aligns with prior AI-driven antigen design work in Nature Biotechnology 2023 on broadly protective influenza constructs, suggesting accelerated iteration cycles compared with traditional structure-based methods. The needle-free platform also addresses cold-chain constraints noted in recent WHO reports on equitable vaccine access.

Larger phase II studies must now test protection against infection and variants in diverse populations, including immunologically naive individuals. Funding sources and long-term durability data remain undisclosed, limiting immediate claims about broad coronavirus coverage.