Vaccine description | |
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Target | SARS-CoV-2 |
Vaccine type | Protein subunit |
Clinical data | |
Routes of administration | Intramuscular |
Part ofa series on the |
COVID-19 pandemic |
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Medical response |
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V-01 is aprotein subunitCOVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.[1][2][3]
Apreclinical study inrhesus 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]
Aphase I clinical trial to assess the safety and immune response was initiated in February 2021. It concluded that the vaccine was well-tolerated.[7] Aphase II trial with 880 participants concluded that the vaccine wasimmunogenic and well-tolerated.[8] A second phase II trial tested V-01 and abivalent version targetingBeta andDelta variants of concern as a booster after primary vaccination with inactivated vaccine.[9]
Aphase III trial using V-01 as a booster was undertaken during anOmicron wave with 10,218 participants in Malaysia and Pakistan to determine efficacy and safety.[10] Participants had been previously vaccinated with two doses ofinactivated vaccine, and wererandomised to either V-01 orplacebo as abooster.[citation needed]
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