HGC019

Last updated

HGC019
Vaccine description
Target SARS-CoV-2
Vaccine type mRNA
Clinical data
Other namesHGCO19, Gemcovac, GEMCOVAC-19
Routes of
administration 		Intramuscular
ATC code
  • None

HGC019 is a mRNA and Self-amplifying mRNA (saRNA) 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 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

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]

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.


This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.