V-01

Vaccine candidate against COVID-19

V-01
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Routes of
administration
Intramuscular
Part of a series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
  • COVID-19 (disease)
  • SARS-CoV-2 (virus)
  • Cases
  • Deaths
virus icon COVID-19 portal
  • v
  • t
  • e

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.[citation needed]

References

  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.
  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.
  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.
  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.
  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.
  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.
  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.
  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.
Scholia has a profile for V-01 (Q106672009).
  • v
  • t
  • e
Pre-pandemic
2020
2021
2022
2023 and after
Africa
Northern
Eastern
Southern
Central
Western
Asia
Central/North
East
Mainland China
South
India
By location
Southeast
Malaysia
Philippines
West
Europe
United Kingdom
By location
Eastern
Western Balkans
European Union
EFTA countries
Microstates
North
America
Atlantic
Canada
Caribbean
Countries
British Overseas Territories
Caribbean Netherlands
French West Indies
US insular areas
Central America
United States
responses
By location
Oceania
Australia
New Zealand
South
America
Others
Culture and
entertainment
Arts and
cultural heritage
Education
By country
Sports
By country
By sport
Society
and rights
Social impact
Labor
Human rights
Legal
Minority
Religion
Economic
By country
By industry
Supply and trade
Financial markets
Information
Misinformation
Politics
Political impact
Protests
International relations
Language
Others
Health issues
Medical topics
Testing and
epidemiology
Apps
Prevention
Vaccines
Topics
Authorized
DNA
Inactivated
mRNA
Subunit
Viral vector
Virus-like particles
In trials
Attenuated
  • COVI-VAC (United States)
DNA
Inactivated
RNA
Subunit
Viral vector
Virus-like particles
Deployment
by location
Africa
Asia
Europe
North America
Oceania
South America
Others
Treatment
Monoclonal antibodies
Small molecule antivirals
Specific
General
Institutions
Hospitals and
medical clinics
Mainland China
Others
Organizations
Global
By location
Health
institutes
Pandemic
institutes
Relief funds
People
Medical
professionals
Researchers
Officials
WHO
  • Tedros Adhanom
  • (Director-General of the WHO)
  • Bruce Aylward
  • (Team lead of WHO-China COVID-19 mission)
  • Maria Van Kerkhove
  • (Technical Lead for COVID-19 response)
  • Michael J. Ryan
  • (Executive Director of the WHO Health Emergencies Programme)
By location
Others
Deaths
Data (templates)
Global
Africa
  • Algeria
  • Angola
  • Benin
  • Botswana
  • Burkina Faso
  • Burundi
  • Cameroon
  • Comoros
  • Egypt
  • Eswatini
  • Ethiopia
  • Ghana
    • cases chart
  • Ivory Coast
  • Kenya
  • Libya
  • Malawi
  • Mali
  • Mauritania
  • Mauritius
  • Morocco (including occupied Western Sahara)
  • Mozambique
  • Namibia
  • Nigera
    • cases chart
  • São Tomé and Príncipe
  • Senegal
  • Seychelles
  • Sierra Leone
  • South Africa
    • cases chart
  • South Sudan
  • Sudan
  • Tanzania
  • Togo
  • Tunisia
  • Uganda
  • Zambia
  • Zimbabwe
    • cases chart
Americas
  • Argentina
  • Bolivia
  • Brazil
  • Canada
    • by province
    • vaccinations by province
  • Chile
    • by commune
  • Colombia
  • Costa Rica
    • cases chart
  • Cuba
  • Dominican Republic
  • Ecuador
  • El Salvador
  • Guatemala
  • Haiti
  • Honduras
  • Mexico
    • cases chart
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • United States
    • by state
  • Uruguay
  • Venezuela
Asia
  • Afghanistan
  • Armenia
    • Artsakh
  • Azerbaijan
  • Bahrain
  • Bangladesh
    • by division
  • Bhutan
    • cases chart
  • Brunei
  • Cambodia
    • cases chart
    • summary
  • China
    • cases chart
    • confirmed per capita
    • lockdowns
    • by province
    • Hong Kong
    • Macau
  • Cyprus
  • East Timor
  • Egypt
  • Georgia
  • India
  • Indonesia
    • cases chart
  • Iran
    • cases chart
  • Iraq
  • Israel
    • cases chart
  • Japan
    • cases chart
  • Jordan
  • Kazakhstan
  • Kuwait
    • cases chart
  • Kyrgyzstan
  • Laos
  • Lebanon
  • Malaysia
    • cases chart
    • charts
  • Myanmar
    • cases chart
    • summary
  • Nepal
    • cases chart
  • Oman
    • cases chart
  • Pakistan
    • cases chart
  • Philippines
    • cases chart
    • areas of quarantine
    • vaccinations chart
  • Qatar
  • Russia
    • cases chart
    • by federal subject
    • North Asia
  • Saudi Arabia
  • Singapore
  • South Korea
    • cases chart
    • vaccinations charts
  • Sri Lanka
  • Syria
  • Taiwan
    • vaccination charts
  • Tajikistan
  • Thailand
    • cases chart
  • Turkey
    • cases chart
  • United Arab Emirates
    • cases chart
  • Uzbekistan
    • cases chart
  • Vietnam
    • statistics charts
  • Yemen
Europe
  • Albania
  • Austria
    • cases chart
  • Belarus
  • Belgium
    • cases chart
  • Bosnia and Herzegovina
  • Bulgaria
    • cases chart
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
    • cases chart
    • Faroe Islands
  • Estonia
    • cases chart
  • Finland
  • France
    • cases chart
  • Germany
    • cases chart
  • Greece
  • Hungary
  • Iceland
    • cases chart
  • Ireland
    • cases chart
  • Italy
    • cases chart
    • statistics charts
    • vaccinations chart
  • Kosovo
  • Latvia
  • cases chart
  • Lithuania
    • cases chart
  • Luxembourg
  • Malta
  • Moldova
  • Monaco
  • Montenegro
  • Netherlands
  • North Macedonia
  • Norway
    • cases chart
  • Poland
    • cases chart
    • by voivodeship
  • Portugal
    • cases chart
  • Romania
  • cases chart
  • Russia
    • cases chart
    • by federal subject
    • North Asia
  • San Marino
  • Serbia
  • Slovakia
    • cases chart
    • by region
  • Slovenia
    • cases chart
  • Spain
    • cases chart
  • Sweden
    • cases chart
  • Switzerland
    • cases chart
  • Turkey
    • cases chart
  • Ukraine
  • United Kingdom
    • Scotland
      • 2020
      • 2021
    • Gibraltar
    • vaccinations chart
      • daily
      • by nation
  • Vatican City
Oceania
  • Australia
    • by state/territory
  • Fiji
  • French Polynesia
  • New Caledonia
  • New Zealand
  • Papua New Guinea
  • Solomon Islands
Others
  • Cruise ships
    • Diamond Princess
  • v
  • t
  • e
Development
Classes
Administration
Vaccines
Bacterial
Viral
Protozoan
Helminthiasis
Other
Inventors/
researchers
Controversy
Related
  • v
  • t
  • e
Pre-pandemic
2020
2021
2022
2023 and after
Africa
Northern
Eastern
Southern
Central
Western
Asia
Central/North
East
Mainland China
South
India
By location
Southeast
Malaysia
Philippines
West
Europe
United Kingdom
By location
Eastern
Western Balkans
European Union
EFTA countries
Microstates
North
America
Atlantic
Canada
Caribbean
Countries
British Overseas Territories
Caribbean Netherlands
French West Indies
US insular areas
Central America
United States
responses
By location
Oceania
Australia
New Zealand
South
America
Others
Culture and
entertainment
Arts and
cultural heritage
Education
By country
Sports
By country
By sport
Society
and rights
Social impact
Labor
Human rights
Legal
Minority
Religion
Economic
By country
By industry
Supply and trade
Financial markets
Information
Misinformation
Politics
Political impact
Protests
International relations
Language
Others
Health issues
Medical topics
Testing and
epidemiology
Apps
Prevention
Vaccines
Topics
Authorized
DNA
Inactivated
mRNA
Subunit
Viral vector
Virus-like particles
In trials
Attenuated
  • COVI-VAC (United States)
DNA
Inactivated
RNA
Subunit
Viral vector
Virus-like particles
Deployment
by location
Africa
Asia
Europe
North America
Oceania
South America
Others
Treatment
Monoclonal antibodies
Small molecule antivirals
Specific
General
Institutions
Hospitals and
medical clinics
Mainland China
Others
Organizations
Global
By location
Health
institutes
Pandemic
institutes
Relief funds
People
Medical
professionals
Researchers
Officials
WHO
  • Tedros Adhanom
  • (Director-General of the WHO)
  • Bruce Aylward
  • (Team lead of WHO-China COVID-19 mission)
  • Maria Van Kerkhove
  • (Technical Lead for COVID-19 response)
  • Michael J. Ryan
  • (Executive Director of the WHO Health Emergencies Programme)
By location
Others
Deaths
Data (templates)
Global
Africa
  • Algeria
  • Angola
  • Benin
  • Botswana
  • Burkina Faso
  • Burundi
  • Cameroon
  • Comoros
  • Egypt
  • Eswatini
  • Ethiopia
  • Ghana
    • cases chart
  • Ivory Coast
  • Kenya
  • Libya
  • Malawi
  • Mali
  • Mauritania
  • Mauritius
  • Morocco (including occupied Western Sahara)
  • Mozambique
  • Namibia
  • Nigera
    • cases chart
  • São Tomé and Príncipe
  • Senegal
  • Seychelles
  • Sierra Leone
  • South Africa
    • cases chart
  • South Sudan
  • Sudan
  • Tanzania
  • Togo
  • Tunisia
  • Uganda
  • Zambia
  • Zimbabwe
    • cases chart
Americas
  • Argentina
  • Bolivia
  • Brazil
  • Canada
    • by province
    • vaccinations by province
  • Chile
    • by commune
  • Colombia
  • Costa Rica
    • cases chart
  • Cuba
  • Dominican Republic
  • Ecuador
  • El Salvador
  • Guatemala
  • Haiti
  • Honduras
  • Mexico
    • cases chart
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • United States
    • by state
  • Uruguay
  • Venezuela
Asia
  • Afghanistan
  • Armenia
    • Artsakh
  • Azerbaijan
  • Bahrain
  • Bangladesh
    • by division
  • Bhutan
    • cases chart
  • Brunei
  • Cambodia
    • cases chart
    • summary
  • China
    • cases chart
    • confirmed per capita
    • lockdowns
    • by province
    • Hong Kong
    • Macau
  • Cyprus
  • East Timor
  • Egypt
  • Georgia
  • India
  • Indonesia
    • cases chart
  • Iran
    • cases chart
  • Iraq
  • Israel
    • cases chart
  • Japan
    • cases chart
  • Jordan
  • Kazakhstan
  • Kuwait
    • cases chart
  • Kyrgyzstan
  • Laos
  • Lebanon
  • Malaysia
    • cases chart
    • charts
  • Myanmar
    • cases chart
    • summary
  • Nepal
    • cases chart
  • Oman
    • cases chart
  • Pakistan
    • cases chart
  • Philippines
    • cases chart
    • areas of quarantine
    • vaccinations chart
  • Qatar
  • Russia
    • cases chart
    • by federal subject
    • North Asia
  • Saudi Arabia
  • Singapore
  • South Korea
    • cases chart
    • vaccinations charts
  • Sri Lanka
  • Syria
  • Taiwan
    • vaccination charts
  • Tajikistan
  • Thailand
    • cases chart
  • Turkey
    • cases chart
  • United Arab Emirates
    • cases chart
  • Uzbekistan
    • cases chart
  • Vietnam
    • statistics charts
  • Yemen
Europe
  • Albania
  • Austria
    • cases chart
  • Belarus
  • Belgium
    • cases chart
  • Bosnia and Herzegovina
  • Bulgaria
    • cases chart
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
    • cases chart
    • Faroe Islands
  • Estonia
    • cases chart
  • Finland
  • France
    • cases chart
  • Germany
    • cases chart
  • Greece
  • Hungary
  • Iceland
    • cases chart
  • Ireland
    • cases chart
  • Italy
    • cases chart
    • statistics charts
    • vaccinations chart
  • Kosovo
  • Latvia
  • cases chart
  • Lithuania
    • cases chart
  • Luxembourg
  • Malta
  • Moldova
  • Monaco
  • Montenegro
  • Netherlands
  • North Macedonia
  • Norway
    • cases chart
  • Poland
    • cases chart
    • by voivodeship
  • Portugal
    • cases chart
  • Romania
  • cases chart
  • Russia
    • cases chart
    • by federal subject
    • North Asia
  • San Marino
  • Serbia
  • Slovakia
    • cases chart
    • by region
  • Slovenia
    • cases chart
  • Spain
    • cases chart
  • Sweden
    • cases chart
  • Switzerland
    • cases chart
  • Turkey
    • cases chart
  • Ukraine
  • United Kingdom
    • Scotland
      • 2020
      • 2021
    • Gibraltar
    • vaccinations chart
      • daily
      • by nation
  • Vatican City
Oceania
  • Australia
    • by state/territory
  • Fiji
  • French Polynesia
  • New Caledonia
  • New Zealand
  • Papua New Guinea
  • Solomon Islands
Others
  • Cruise ships
    • Diamond Princess
Portals:
  • icon Medicine
  • icon Viruses
  • virus icon COVID-19
Stub icon

This article about COVID-19 vaccines is a stub. You can help Wikipedia by expanding it.

  • v
  • t
  • e
Stub icon

This article about the COVID-19 pandemic is a stub. You can help Wikipedia by expanding it.

  • v
  • t
  • e
Stub icon

This article about vaccines or vaccination is a stub. You can help Wikipedia by expanding it.

  • v
  • t
  • e