Medicine:HGC019
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | mrna |
| Clinical data | |
| Other names | HGCO19, Gemcovac, GEMCOVAC-19 |
| Routes of administration | Intramuscular |
| ATC code |
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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]
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]
References
- ↑ "mRNA Vaccines – HGC019". https://gennova.bio/mrna-vaccines/.
- ↑ "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.
- ↑ "Pune-based Gennova to begin human trials of its Covid vaccine 'soon'". The Indian Express. 15 December 2020. https://indianexpress.com/article/india/pune-based-gennova-to-begin-human-trials-of-its-covid-vaccine-soon-7105081/.
- ↑ 4.0 4.1 "Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants.". Clinical Trials Registry India. http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=54697&EncHid=&userName=HGCO199.
- ↑ "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.
- ↑ "India's first mRNA vaccine found to be safe, given nod for Phase II/III trial" (in en). mint. 24 August 2021. https://www.livemint.com/news/india/indias-first-mrna-based-covid-vaccine-found-to-be-safe-given-nod-for-phase-ii-iii-trial-11629798997685.html.
- ↑ "India approves further trials for first homegrown mRNA COVID-19 shot" (in en). Reuters. 24 August 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/indian-drug-regulators-say-gennovas-covid-19-vaccine-safe-early-trials-2021-08-24/.
- ↑ "Trials of India's first mRNA Covid vaccine by Gennova on track". The Financial Express. 26 May 2021. https://www.financialexpress.com/lifestyle/health/trials-of-indias-first-mrna-covid-vaccine-by-gennova-on-track/2258977/.
External links
- "India's mRNA vaccine candidate advances to human trial phase" (in en). Hindustan Times. https://www.hindustantimes.com/india-news/india-s-mrna-vaccine-candidate-advances-to-human-trial-phase/story-euXWYNfRxfLKT84B7ntmjL.html.
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