V-01

V-01
Vaccine description
Target	SARS-CoV-2
Vaccine type	Protein subunit
Clinical data
Routes of; administration	Intramuscular

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

Preclinical studies

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]

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.

References

"China approves clinical trials for Livzon Pharma unit's COVID-19 vaccine". Reuters. 23 March 2021. 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.
Sun S, Cai Y, Song TZ, Pu Y, Cheng L, Xu H, et al. (September 2021). "Interferon-armed RBD dimer enhances the immunogenicity of RBD for sterilizing immunity against SARS-CoV-2". Cell Research. 31 (9): 1011–1023. doi:10.1038/s41422-021-00531-8. PMC 8280646. PMID 34267349.
Sun S, Chen X, Lin J, Ai J, Yang J, Hu Z, et al. (November 2021). "Broad neutralization against SARS-CoV-2 variants induced by a next-generation protein vaccine V-01". Cell Discovery. 7 (1): 114. doi:10.1038/s41421-021-00350-6. PMC 8630016. PMID 34845195.
Song S, Zhou B, Cheng L, Liu W, Fan Q, Ge X, et al. (January 2022). "Sequential immunization with SARS-CoV-2 RBD vaccine induces potent and broad neutralization against variants in mice". Virology Journal. 19 (1): 2. doi:10.1186/s12985-021-01737-3. PMC 8724645. PMID 34983583.
Zhang J, Hu Z, He J, Liao Y, Li Y, Pei R, et al. (December 2021). "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". Emerging Microbes & Infections. 10 (1): 1589–1597. doi:10.1080/22221751.2021.1951126. PMC 8366678. PMID 34197281.
Shu YJ, He JF, Pei RJ, He P, Huang ZH, Chen SM, et al. (July 2021). "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". Chinese Medical Journal. 134 (16): 1967–1976. doi:10.1097/CM9.0000000000001702. PMC 8382383. PMID 34310400.
Zhang Z, He Q, Zhao W, Li Y, Yang J, Hu Z, et al. (July 2022). "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 of Clinical Medicine. 11 (14): 4164. doi:10.3390/jcm11144164. PMC 9317108. PMID 35887928.
Wang XY, Mahmood SF, Jin F, Cheah WK, Ahmad M, Sohail MA, et al. (December 2022). "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". Emerging Microbes & Infections. 11 (1): 1910–1919. doi:10.1080/22221751.2022.2088406. PMC 9347473. PMID 35686572.

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[1] "China approves clinical trials for Livzon Pharma unit's COVID-19 vaccine". Reuters. 23 March 2021. Retrieved 21 April 2021.

[2] "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.

[3] "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.

[Macaques-4] Sun S, Cai Y, Song TZ, Pu Y, Cheng L, Xu H, et al. (September 2021). "Interferon-armed RBD dimer enhances the immunogenicity of RBD for sterilizing immunity against SARS-CoV-2". Cell Research. 31 (9): 1011–1023. doi:10.1038/s41422-021-00531-8. PMC 8280646. PMID 34267349.

[Preclinical_VOCs-5] Sun S, Chen X, Lin J, Ai J, Yang J, Hu Z, et al. (November 2021). "Broad neutralization against SARS-CoV-2 variants induced by a next-generation protein vaccine V-01". Cell Discovery. 7 (1): 114. doi:10.1038/s41421-021-00350-6. PMC 8630016. PMID 34845195.

[Mice_-_booster-6] Song S, Zhou B, Cheng L, Liu W, Fan Q, Ge X, et al. (January 2022). "Sequential immunization with SARS-CoV-2 RBD vaccine induces potent and broad neutralization against variants in mice". Virology Journal. 19 (1): 2. doi:10.1186/s12985-021-01737-3. PMC 8724645. PMID 34983583.

[Phase_1-7] Zhang J, Hu Z, He J, Liao Y, Li Y, Pei R, et al. (December 2021). "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". Emerging Microbes & Infections. 10 (1): 1589–1597. doi:10.1080/22221751.2021.1951126. PMC 8366678. PMID 34197281.

[Phase_2-8] Shu YJ, He JF, Pei RJ, He P, Huang ZH, Chen SM, et al. (July 2021). "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". Chinese Medical Journal. 134 (16): 1967–1976. doi:10.1097/CM9.0000000000001702. PMC 8382383. PMID 34310400.

[Phase_2_booster-9] Zhang Z, He Q, Zhao W, Li Y, Yang J, Hu Z, et al. (July 2022). "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 of Clinical Medicine. 11 (14): 4164. doi:10.3390/jcm11144164. PMC 9317108. PMID 35887928.

[Phase_3_booster-10] Wang XY, Mahmood SF, Jin F, Cheah WK, Ahmad M, Sohail MA, et al. (December 2022). "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". Emerging Microbes & Infections. 11 (1): 1910–1919. doi:10.1080/22221751.2022.2088406. PMC 9347473. PMID 35686572.