If all goes well, Phase-II clinical trials of Russian vaccine Sputnik V will commence at state government-run College of Medicine and Sagore Dutta Hospital by the end of this month, a senior official of the health department said on Tuesday. The necessary surveys – which include visiting the hospital to check its infrastructure and cold storage facilities – have been carried out by a site management organization before starting the process, he stated.
Snehendu Koner, the head of business development at site management organization CliniMed LifeSciences, said a report on survey findings has been sent to the Drug Control General of India (DCGI) for approval.
“We have visited the site, conducted checks on its infrastructure as well as facilities for storing vaccines and immunogenicity samples.
“We have also gone through the hospital’s records and found it has experiences of conducting clinical trials. Our findings are quite satisfactory, and we have sent it to the DCGI for approval,” Koner told PTI when contacted.
Once the DCGI gives green signal, the hospital’s ethics committee will issue a clearance to start the Phase-II clinical trials there, he said.
“We have also identified the principal investigator as well the co-investigator for the process,” he said.
The clinical trial of Sputnik V, scheduled to be held throughout the country, will be conducted by pharma company Dr Reddy’s Lab, which has joined hands with the Russian Direct Investment Fund (RDIF).
According to a health department official, the RDIF will be supplying 100 million doses of its potential COVID-19 vaccine to Dr Reddy’s Lab.
Hundred volunteers will be chosen all over the country, and out of them 75 will be administered the vaccine.
Twenty-five others will be given placebo – a substance or treatment which is designed to have no therapeutic value.