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HGC019

From Wikipedia, the free encyclopedia
Vaccine hopeful against COVID-19

Pharmaceutical compound
HGC019
Vaccine description
TargetSARS-CoV-2
Vaccine typemRNA
Clinical data
Other namesHGCO19, Gemcovac, GEMCOVAC-19
Routes of
administration
Intramuscular
ATC code
  • None
Part ofa 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.
virus iconCOVID-19 portal

HGC019 is amRNA and Self-amplifying mRNA (saRNA) basedCOVID-19 vaccine candidate being developed by Gennova Biopharmaceuticals and HDT Bio Corp. with active support fromNIH under The Indo-US Vaccine Action Program (VAP) andDepartment of Biotechnology, India.[1]

Clinical trials

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The phase-I trials began in February 2021 after receiving permission fromDrugs Controller General of India (DGCI),[2][3] to evaluate the safety andimmunogenicity of the vaccine candidate in about 120 participants consisting of age group (18–70) years.[4]

The phase-II trials is planned to conduct with 500 participants from the age group (18–75) years.[4] On 24 August 2021, theDrugs Controller General of India gave a go for phase II/III trials after it was found to be safe, tolerable, and immunogenic in the phase I trial results.[5][6][7]

Economics

[edit]

The company has received a funding of ₹250 crore (around US$33.5 million) fromGovernment of India based on the clinical trials progress.[8]

References

[edit]
  1. ^"mRNA Vaccines – HGC019".Gennova Biopharmaceuticals Limited. Archived fromthe original on 3 May 2021. Retrieved13 January 2021.
  2. ^"Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller nod to initiate Human clinical trials" (Press release).Press Information Bureau. Retrieved13 January 2021.
  3. ^Raghavan P (15 December 2020)."Pune-based Gennova to begin human trials of its Covid vaccine 'soon'".The Indian Express.
  4. ^ab"Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants".ctri.nic.in. Clinical Trials Registry India. Retrieved5 June 2021.
  5. ^"DBT-BIRAC supported Nation's first mRNA-based vaccine found to be safe gets a nod from the Drugs Controller General of India DCG(I) to move into Phase II/III trial" (Press release).Press Information Bureau. Retrieved25 August 2021.
  6. ^"India's first mRNA vaccine found to be safe, given nod for Phase II/III trial".mint. 24 August 2021.
  7. ^Singh S (24 August 2021)."India approves further trials for first homegrown mRNA COVID-19 shot".Reuters.
  8. ^Geeta N (26 May 2021)."Trials of India's first mRNA Covid vaccine by Gennova on track".The Financial Express.

External links

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Scholia has a profile forHGC019(Q106370223).


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