HGC019

HGC019
Vaccine description
Target	SARS-CoV-2
Vaccine type	mRNA
Clinical data
Other names	HGCO19, 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]

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

^ "mRNA Vaccines – HGC019". Gennova Biopharmaceuticals Limited. Archived from the original on 3 May 2021. Retrieved 13 January 2021.
^ "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.
^ Raghavan P (15 December 2020). "Pune-based Gennova to begin human trials of its Covid vaccine 'soon'". The Indian Express.
^ ^a ^b "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.
^ "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". mint. 24 August 2021.
^ Singh S (24 August 2021). "India approves further trials for first homegrown mRNA COVID-19 shot". Reuters.
^ Geeta N (26 May 2021). "Trials of India's first mRNA Covid vaccine by Gennova on track". The Financial Express.

External links

"India's mRNA vaccine candidate advances to human trial phase". Hindustan Times.

[1] "mRNA Vaccines – HGC019". Gennova Biopharmaceuticals Limited. Archived from the original on 3 May 2021. Retrieved 13 January 2021.

[HGC019-2] "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.

[CTRI/2021/04/032688-4] "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.

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