India’s first mRNA-based Covid-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been given approval for phase 2/3 clinical trials, informed the department of biotechnology (DBT) said on Tuesday.
It said, the interim clinical data of the vaccine’s phase 1 study had been submitted by the Pune-based biotechnology company to the central drugs standard control organization. The interim phase 1 data was reviewed by the vaccine subject expert committee which 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 DCG(I), CDSCO,” the DBT said.
At approximately 10-15 sites in phase 2 and 22-27 sites in phase 3 the study will be conducted. 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 partially funded by the DBT.
