The study will be conducted across approximately 10-15 sites in Phase II and 22-27 sites in Phase III
India’s first mRNA vaccine against coronavirus – developed by Pune-based Gennova Biopharmaceuticals Ltd (part of Emcure group of companies) – has been found to be safe and it has been given the go-ahead from the Drugs Controller General of India (DCGI) to move into Phase II and III of clinical trials.
The firm had submitted the interim clinical data of its Phase I trial to the Central Drugs Standard Control Organisation (CDSCO), the Government of India’s National Regulatory Authority.
“We had enrolled 82 participants across three trial sites (two in Pune and one in Kolhapur) in the Phase 1 trial (of the vaccine, HGCO190), which has been completed. Safety data was good enough and approval has been given for phase II and III trials that are now expected to begin in the next two weeks,” Dr Sanjay Singh, CEO of Gennova Biopharmaceuticals Ltd, told The Indian Express.
The vaccine Subject Expert Committee reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study.
Gennova submitted the proposed Phase II and Phase III study titled ‘A prospective, multi-centre, 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 in healthy subjects‘, which was approved by the office of the DCG(I), CDSCO.
The study will be conducted across approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the Department of Biotechnology-Indian Council of Medical Research clinical trial network sites for this study. “We hope to enroll 4,400 participants,” said Dr Singh.
“We are aiming to roll out the vaccine as early as possible – even by the year end – and initially it will be for adults before we work on one for children,” said Dr Singh. Gennova is investing in scaling up its manufacturing capacity to cater to the nation’s vaccine requirement, he added.
Gennova’s mRNA-based Covid-19 vaccine development programme was partly funded by the DBT under the Ind CEPI Mission, back in June 2020. The DBT further supported the programme under the Mission Covid Suraksha – the Indian Covid-19 Vaccine Development Mission, implemented by Biotechnology Industry Research Assistance Council (BIRAC).
In a statement, Dr Renu Swarup, secretary, DBT and chairperson, BIRAC, said, “It is a matter of great pride that the nation’s first mRNA-based vaccine was found to be safe and the Drugs Controller General of India has approved Phase II and III trials. We are confident that this will be an important vaccine for both India and the world. This is an important milestone in our indigenous vaccine development mission and positions India on the global map for novel vaccine development.”
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