V-01

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| target = SARS-CoV-2

| vaccine_type = protein

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| routes_of_administration = Intramuscular

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V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.{{cite news |title=China approves clinical trials for Livzon Pharma unit's COVID-19 vaccine |url=https://www.reuters.com/article/us-health-coronavirus-vaccine-livzon-idUSKBN2BF20A |access-date=21 April 2021 |publisher=Reuters |date=23 March 2021}}{{cite web |title=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 | trans-title = 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 | language = Chinese |url=http://www.chictr.org.cn/showproj.aspx?proj=124702 |website=chictr.org.cn |publisher=Chinese Clinical Trial Registry |access-date=21 April 2021 }}{{cite web |title=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 | trans-title = 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 | language = Chinese |url=http://www.chictr.org.cn/showproj.aspx?proj=124140 |website=chictr.org.cn |publisher=Chinese Clinical Trial Registry |access-date=21 April 2021 }}

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Preclinical studies

A preclinical study in rhesus macaques was published in July 2021.{{cite journal | vauthors = Sun S, Cai Y, Song TZ, Pu Y, Cheng L, Xu H, Sun J, Meng C, Lin Y, Huang H, Zhao F, Zhang S, Gao Y, Han JB, Feng XL, Yu DD, Zhu Y, Gao P, Tang H, Zhao J, Zhang Z, Yang J, Hu Z, Fu YX, Zheng YT, Peng H | display-authors = 6 | title = Interferon-armed RBD dimer enhances the immunogenicity of RBD for sterilizing immunity against SARS-CoV-2 | journal = Cell Research | volume = 31 | issue = 9 | pages = 1011–1023 | date = September 2021 | pmid = 34267349 | doi = 10.1038/s41422-021-00531-8 | pmc = 8280646 }} The vaccine's ability to neutralize several variants of concern has also been tested in mice.{{cite journal | vauthors = Sun S, Chen X, Lin J, Ai J, Yang J, Hu Z, Fu YX, Peng H | display-authors = 6 | title = Broad neutralization against SARS-CoV-2 variants induced by a next-generation protein vaccine V-01 | journal = Cell Discovery | volume = 7 | issue = 1 | pages = 114 | date = November 2021 | pmid = 34845195 | doi = 10.1038/s41421-021-00350-6 | pmc = 8630016 }} Another study in mice tested V-01 as a booster after inactivated Covid vaccine, including neutralization of a range of variants of concern.{{cite journal | vauthors = Song S, Zhou B, Cheng L, Liu W, Fan Q, Ge X, Peng H, Fu YX, Ju B, Zhang Z | display-authors = 6 | title = Sequential immunization with SARS-CoV-2 RBD vaccine induces potent and broad neutralization against variants in mice | journal = Virology Journal | volume = 19 | issue = 1 | pages = 2 | date = January 2022 | pmid = 34983583 | doi = 10.1186/s12985-021-01737-3 | pmc = 8724645 | doi-access = free }}

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.{{cite journal | vauthors = Zhang J, Hu Z, He J, Liao Y, Li Y, Pei R, Fang X, Zeng P, Fan R, Ou Z, Deng J, Zhou J, Guan W, Min Y, Deng F, Peng H, Zhang Z, Feng C, Xin B | display-authors = 6 | title = Safety and immunogenicity of a recombinant interferon-armed RBD dimer vaccine (V-01) for COVID-19 in healthy adults: a randomized, double-blind, placebo-controlled, Phase I trial | journal = Emerging Microbes & Infections | volume = 10 | issue = 1 | pages = 1589–1597 | date = December 2021 | pmid = 34197281 | doi = 10.1080/22221751.2021.1951126 | pmc = 8366678 }} A phase II trial with 880 participants concluded that the vaccine was immunogenic and well-tolerated.{{cite journal | vauthors = Shu YJ, He JF, Pei RJ, He P, Huang ZH, Chen SM, Ou ZQ, Deng JL, Zeng PY, Zhou J, Min YQ, Deng F, Peng H, Zhang Z, Wang B, Xu ZH, Guan WX, Hu ZY, Zhang JK | display-authors = 6 | title = Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial | journal = Chinese Medical Journal | volume = 134 | issue = 16 | pages = 1967–1976 | date = July 2021 | pmid = 34310400 | doi = 10.1097/CM9.0000000000001702 | pmc = 8382383 }} 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.{{cite journal | vauthors = Zhang Z, He Q, Zhao W, Li Y, Yang J, Hu Z, Chen X, Peng H, Fu YX, Chen L, Lu L | display-authors = 6 | title = A Heterologous V-01 or Variant-Matched Bivalent V-01D-351 Booster following Primary Series of Inactivated Vaccine Enhances the Neutralizing Capacity against SARS-CoV-2 Delta and Omicron Strains | journal = Journal of Clinical Medicine | volume = 11 | issue = 14 | pages = 4164 | date = July 2022 | pmid = 35887928 | doi = 10.3390/jcm11144164 | pmc = 9317108 | doi-access = free }}

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.{{cite journal | vauthors = Wang XY, Mahmood SF, Jin F, Cheah WK, Ahmad M, Sohail MA, Ahmad W, Suppan VK, Sayeed MA, Luxmi S, Teo AH, Lee LY, Qi YY, Pei RJ, Deng W, Xu ZH, Yang JM, Zhang Y, Guan WX, Yu X | display-authors = 6 | title = Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial | journal = Emerging Microbes & Infections | volume = 11 | issue = 1 | pages = 1910–1919 | date = December 2022 | pmid = 35686572 | doi = 10.1080/22221751.2022.2088406 | pmc = 9347473 }} Participants had been previously vaccinated with two doses of inactivated vaccine, and were randomised to either V-01 or placebo as a booster.{{cn|date=February 2023}}

References

Category:Clinical trials related to COVID-19

Category:Chinese COVID-19 vaccines

Category:Science and technology in China

Category:Protein subunit vaccines