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]
Clinical studies
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]
^"评价重组新型冠状病毒融合蛋白疫苗在健康人群免疫原性和安全性随机、双盲、安慰剂对照的II期临床试验" [A randomized, double-blind, placebo-controlled phase II clinical trial evaluating the immunogenicity and safety of a recombinant novel coronavirus fusion protein vaccine in healthy people]. chictr.org.cn (in Chinese). Chinese Clinical Trial Registry. Retrieved 21 April 2021.
^"评价重组新型冠状病毒融合蛋白疫苗在健康人群安全性和免疫原性随机、双盲、安慰剂对照的I期临床试验" [A randomized, double-blind, placebo-controlled phase I clinical trial evaluating the safety and immunogenicity of a recombinant novel coronavirus fusion protein vaccine in healthy people]. chictr.org.cn (in Chinese). Chinese Clinical Trial Registry. Retrieved 21 April 2021.
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