Clinical Trials on India's First mRNA Covid-19 Vaccine to Begin Soon
Published On Apr 15, 2021 12:00 AM By Yamini Sharma
According to latest reports, clinical trials for India’s first mRNA-based Covid-19 vaccine, HGCO19 are expected to begin soon. As of now, Emcure Group firm, Gennova Biopharmaceuticals, the developer of HGCO19 is planning to commence recruitment for phase 1 clinical trials in a week. Vikas Thapar, President- Corporate Development & Strategy, Emcure Group informed that the firm has received the final nod from the regulator last week to begin the phase 1 clinical trials. He furthermore confirmed that phase 1 would be conducted on about 150 people.
Reports suggest that for the first and second phase trials, Gennova Biopharmaceuticals will enroll about 620 participants. The safety, tolerability and immunogenicity of the vaccine in healthy adults between the age of 18 years to 70 years will be evaluated in the trials. HGCO19 has already demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent as well as non-human primate models. The neutralising antibody response of the novel coronavirus vaccine in mice and non-human primates was compared with the sera from the convalescent patients of COVID-19.
It must be noted that Gennova Biopharmaceuticals has developed the COVID-19mRNA vaccine - HGCO19 in collaboration with HDT Biotech Corporation, USA. Moreover, The Department of Biotechnology (DBT) in Ministry of Science & Technology approved additional funding towards clinical studies of HGCO19, the first mRNA-based coronavirus vaccine. The funding has been awarded under the ‘Mission Covid Suraksha- The Indian Covid-19 Vaccine Development Mission’.
As per the company’s claims, the vaccine is unique since it uses the most prominent mutant of spike protein (D614G) and is based on self-amplifying mRNA platform. It must be noted that the coronavirus vaccine is stable at 2 to 8 degrees Celsius, which could be a significant advantage for India, thereby allowing easier distribution and administration across the country.
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Disclaimer: This article is issued in the general public interest and meant for general information purposes only. Readers are advised not to rely on the contents of the article as conclusive in nature and should research further or consult an expert in this regard.