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]
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]
Economicsedit
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]
^"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.
^ ab"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.
hgc019, mrna, self, amplifying, mrna, sarna, based, covid, vaccine, candidate, being, developed, gennova, biopharmaceuticals, corp, with, active, support, from, under, indo, vaccine, action, program, department, biotechnology, india, vaccine, descriptiontarget. 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 HGC019Vaccine descriptionTargetSARS CoV 2Vaccine typemRNAClinical dataOther namesHGCO19 Gemcovac GEMCOVAC 19Routes ofadministrationIntramuscularATC codeNone Contents 1 Clinical trials 2 Economics 3 References 4 External linksClinical trials editThe 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 editThe 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 edit mRNA Vaccines HGC019 Gennova Biopharmaceuticals Limited 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 edit nbsp Scholia has a profile for HGC019 Q106370223 India s mRNA vaccine candidate advances to human trial phase Hindustan Times Portals nbsp Medicine nbsp Viruses nbsp COVID 19 nbsp This article about COVID 19 vaccines is a stub You can help Wikipedia by expanding it vte nbsp This article about vaccines or vaccination is a stub You can help Wikipedia by expanding it vte Retrieved from https en wikipedia org w index php title HGC019 amp oldid 1179057626, wikipedia, wiki, book, books, library,
