In Phase III, St. George's Hospital has recruited 144 participants out of which 108 have been given Sputnik V vaccine and 36 a placebo.
The recruitment of 1,500 participants in India’s Phase-III human trials for Sputnik vaccine got over late last month with five hospital sites in Maharashtra completing their first shot. In Mumbai, St George’s Hospital is the only site conducting clinical trials for the Russian vaccine. Across India, 21 hospital sites are taking part in the trial.
St George’s recruited 18 participants in the Phase-II trial that ended in December. In Phase III, it has recruited 144 participants by January 30, of which 108 have been given the vaccine and 36 a placebo. Medical Superintendent Dr Akash Khobragade said they will be receiving a phased stock of 44 doses to conduct the trial.
Sputnik V uses two different vectors for two shots in the course of the vaccination. The latest efficacy data by Russian Direct Investment Fund (RDIF), published in Lancet, states that the vaccine is 91.6 per cent efficacious. In September 2020, Dr Reddy’s laboratories partnered with RDIF to undertake clinical trials of the vaccine and for its distribution rights in India. The Phase-II trials ended in December. It is undergoing a Phase-III trial to cover 1,500 participants to measure safety and immunogenicity of the human adenovirus vaccine.
In Mumbai, out of 144 participants aged above 18, one is aged between 55 and 60 but with no severe co-morbidities. The hospital site tried to rope in senior citizens but did not find volunteers in that age group. The first shot was administered to all participants and the second will be given after 21 days. Adverse event in Mumbai were noted to be limited to fever. Khobragade said no severe illness were noted.
At Aurangabad MGM Medical College and Hospital, 55 participants were recruited for the trial. A doctor from the hospital said they had enough stock to undertake the second dosage. He added that they had, so far, observed no severe adverse reaction. At Pune’s KEM hospital, the recruitment of all participants is over too. Other centres in the state are Noble Hospital and BJ Government Medical College, both in Pune.
An official from Dr Reddy’s said the recruitment of 1,500 participants was over and the second shot will be administered towards the end of this month. The hospital sites will observe participants for the next seven months, the official added.
The vaccine has, so far, been approved in 18 countries, including Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia and Mexico.
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