Open Orphan and Codagenix have received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a Phase I study of its COVID-19 vaccine.
The study will assess the safety and immunogenicity of a single-dose nasal vaccine candidate COVI-VAC in 48 healthy young adult volunteers.
COVI-VAC uses the entire virus in a weakened form, and so has the potential to induce broad antibody, cellular and mucosal immunity with a single intra-nasal dose.
According to Open Orphan, it could be one of the first vaccines to provide long-term immunity from COVID-19.
“We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines,” added Sybil Tasker, Codagenix’ chief medical officer.
The study is expected to begin next month, with first data read outs expected in early Q2 2020.