HGC019

Last updated

HGC019
Vaccine description
Target SARS-CoV-2
Vaccine type mRNA
Clinical data
Other namesHGCO19
Routes of
administration
Intramuscular
ATC code
  • None

HGC019 is a mRNA based COVID-19 vaccine candidate being developed by Gennova Biopharmaceuticals and HDT Bio Corp. with active support from NIH under The Indo-US Vaccine Action Program (VAP) and Department of Biotechnology, India. [1]

Contents

Clinical trials

The phase-I trials began in February 2021 after receiving permission from Drugs Controller General of India (DGCI), [2] [3] to evaluate the safety and immunogenicity 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, the Drugs Controller General of India gave a go ahead for phase II/III trials after it was found to safe, tolerable, and immunogenic in the phase I trial results. [5] [6] [7]

Economics

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

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References

  1. "mRNA Vaccines – HGC019". Gennova Biopharmaceuticals Limited. Retrieved 13 January 2021.
  2. "Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller nod to initiate Human clinical trials" (Press release). Press Information Bureau . Retrieved 13 January 2021.
  3. Raghavan P (15 December 2020). "Pune-based Gennova to begin human trials of its Covid vaccine 'soon'". The Indian Express.
  4. 1 2 "Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants". ctri.nic.in. Clinical Trials Registry India. Retrieved 5 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 . Retrieved 25 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.