Gennova gets DCGI nod for Phase 2, 3 trials of its mRNA COVID vaccine
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New Delhi: India's first mRNA-based Covid-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for phase 2/3 clinical trials, the department of biotechnology (DBT) said on Tuesday.
The Pune-based biotechnology company had submitted the interim clinical data of the vaccine's phase 1 study to the central drugs standard control organisation, it said.
The vaccine subject expert committee reviewed the interim phase 1 data and found that the HGCO19 vaccine was safe, tolerable, and immunogenic in the participants of the study.
"Gennova submitted the proposed phase 2 and phase 3 study entitled 'A prospective, multicentre, randomised, active-controlled, observer-blind, phase 2 study seamlessly followed by a phase 3 study to evaluate the safety, tolerability, and immunogenicity of the candidate HGCO19 (Covid-19 vaccine) in healthy subjects' which was approved by the office of the DCGI, CDSCO," the DBT said.
The study will be conducted at approximately 10-15 sites in phase 2 and 22-27 sites in phase 3. Gennova plans to use the DBT-ICMR clinical trial network sites for this study, it said.
Gennova's mRNA-based Covid-19 vaccine development programme was partly funded by the DBT.
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