Clinical trials for Russian COVID-19 vaccine candidate Sputnik V have commenced in India and are set to involve 1,600 volunteers at nine sites across the country. Dr. Reddy’s Laboratories and the Russian Direct Investment Fund, which partnered the drugmaker for the trials and distribution of the first 100 million doses in India, on Tuesday said the adaptive phase 2/3 trials had begun after receiving clearance from the Central Drugs Laboratory, Kasauli.
It will be a multicentre and randomised controlled study. The Clinical Trials Registry-India said the trials were planned to be conducted on 1,600 subjects — 100 in phase II and 1,500 in phase III.
Nine sites have been identified for the study, including two in Pune. The other sites are in Vellore, Puducherry, Lucknow, Kanpur, Belgaum, Mysuru and Jaipur, according to information on the CTRI website about the randomised, double-blind, placebo-controlled, parallel-group, multi-centre Phase II/III adaptive clinical trials. The estimated duration of the trial is seven months. Dr. Reddy’s CEO Erez Israeli had earlier said Phase III trials, depending on compilation of data from Phase-II and regulatory approvals, could be completed as early as March or even stretch up to May.
The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Dr. Reddy’s has partnered with the Department of Biotechnology’s Biotechnology Industry Research Assistance Council (BIRAC) for advisory support and to use the Council’s clinical trial centres for the vaccine.
The release said RDIF had recently announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose; and efficacy of more than 95%, 42 days from the first dose. It had said 40,000 volunteers (in other countries) were taking part in Phase III of Sputnik V clinical trials, out of which more than 22,000 had been vaccinated with the first dose of the vaccine and more than 19,000, with both the first and second doses of the vaccine.
Dr. Reddy’s co-chairman and MD G.V. Prasad described the launch of the clinical trials as a significant step “as we continue to collaborate with multiple entities along with government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.”
Last week, RDIF had announced a collaboration with Hetero Biopharma under which more than 100 million doses of Sputnik V in India are to be produced a year at the latter’s facility in Hyderabad, beginning early 2021.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, with the backing of RDIF, Sputnik V was registered by the Russian Ministry of Health in August and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.
Sputnik V will join a growing list of COVID-19 vaccine candidates whose trials are underway, including Bharat Biotech’s Covaxin and AstraZeneca and the Oxford Vaccine Group’s Covishield that is being tested in the country by the Serum Institute of India.
