Second phase of trial: 14 in Tamil Nadu get vaccine shots

CHENNAI: The phase-2 human clinical trials of indigenous Covid-19 vaccine Covaxin began at SRM Medical College Hospital and Research Centre at Kattankulathur with 14 volunteers administered a shot of the vaccine on Tuesday. Doctors said they will have enough data before the year-end to decide if the vaccine could be officially launched. SRM was one of 12 institutions chosen by ICMR to conduct trials of the vaccine developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology, reports U Tejonmayam.
The phase-1 trials began on July 23 and around 30 volunteers were administered two doses, each 0.05ml, of the vaccine, which contains inactivated coronavirus to provoke immune response. After the volunteers showed no side effects and their blood samples were sent to ICMR, 14 were given shots under phase-2 trials. They will be given a second shot on day 28. In phase-2, parameters like immunogenicity or the vaccine’s ability to provoke an immune response, the antibody titer, which is a test to detect the presence and measure the amount of antibodies present in a person’s blood as well as the safety of the vaccine will be analysed.
“This is the dose selection phase. We had three formulations in phase-1 and we chose two of them for phase-2. Finally, one with better results in phase-2 will be chosen and given to volunteers in phase-3 trials,” said Dr Satyajit Mohapatra, principal investigator at the hospital. “Certainly, before the end of this year we will have results to see whether we can bring out the vaccine or not,” he added.
In phase-2, around 50 volunteers will be administered two doses on day one and 28. They will have to visit the hospital for a follow up on day 42, 56, third month and on the sixth month. Unlike phase-1 which involved 30 volunteers per testing site in the age group of 18 to 55 years, phase-2 will have around 50 volunteers per site in the age group of 12 to 65 years. “Based on the data and the analysis of blood samples in phase-2, phase-3 trial may be decided, which will have volunteers in the 1000s,” he said.
The state health department has, meanwhile, called for volunteers for the phase-2 human clinical trials of Covishield vaccine developed by Oxford University, which reached the city on September 3. The vaccine will be tested on volunteers at Rajiv Gandhi Government General Hospital and Sri Ramachandra Institute of Higher Education and Research, Porur, as part of a multi-centric study in India.
“This phase requires 110 to 150 volunteers,” said Dr TS Selvavinayagam, director of public health and principal investigator for the project.