Gennova Biopharmaceuticals, the Pune-based biotechnology company which is developing India's first mRNA-based COVID-19 vaccine HGCO19, on August 24 received approval from the Drug Controller General of India (DCGI) to conduct Phase 2 and Phase 3 clinical trials.
Gennova submitted the proposed Phase II and Phase III study titled 'A Prospective, Multicentre, Randomised, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III 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.
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study.
The company submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA).