V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.^[1][2][3]

A preclinical study in rhesus macaques was published in July 2021.^[4] The vaccine's ability to neutralize several variants of concern has also been tested in mice.^[5] Another study in mice tested V-01 as a booster after inactivated Covid vaccine, including neutralization of a range of variants of concern.^[6]

A phase I clinical trial to assess the safety and immune response was initiated in February 2021. It concluded that the vaccine was well-tolerated.^[7] A phase II trial with 880 participants concluded that the vaccine was immunogenic and well-tolerated.^[8] A second phase II trial tested V-01 and a bivalent version targeting Beta and Delta variants of concern as a booster after primary vaccination with inactivated vaccine.^[9]

A phase III trial using V-01 as a booster was undertaken during an Omicron wave with 10,218 participants in Malaysia and Pakistan to determine efficacy and safety.^[10] Participants had been previously vaccinated with two doses of inactivated vaccine, and were randomised to either V-01 or placebo as a booster.^{[citation needed]}