Serum Institute gets DCGI nod to conduct phase 2, 3 human trials of Oxford vaccine in 1,600 healthy volunteers in India
Serum Institute has partnered with AstraZeneca to manufacture the vaccine, saying in a statement that it will make a billion doses once cleared by regulatory authorities.
The Drugs Controller General of India has given the Serum Institute of India a green light to conduct phase 2 and 3 human trials of the Oxford-AstraZeneca COVID-19 vaccine candidate in India.
The approval came from DCGI Dr V G Somani, who declared after a thorough evaluation and recommendations from the Subject Expert Committee (SEC) on COVID-19, that Serum Institute was permitted to carry out the trials. The committee, which met on Tuesday to deliberated on SII's application, had asked Serum Institute to revise its protocol for phase 2 and 3 clinical trials, besides seeking some additional information.
"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," an official told Press Trust of India.
Currently, the Oxford-AstraZeneca vaccine candidate (called AZD1222) is in the midst of phase 2 and 3 clinical trials in the United Kingdom, phase 3 trials in Brazil, and phase 1 and 2 clinical trials in South Africa. In data released from the phase 1/2 study in 1,077 healthy volunteers, AZD1222 was found to trigger two unique, important immune responses against COVID-19.
The CDSCO expert panel had also suggested that Serum Institute pick clinical trial sites distributed widely across India. As per Serum's revised proposal, 1,600 healthy volunteers over age 18 will be enrolled in trials conducted in 17 chosen sites – AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore, a PTI report says.
The phase 2 and 3 trials will be an observer-blind, randomized controlled study to determine the safety and immunogenicity of the Oxford vaccine, dubbed 'Covishield', on healthy Indian adults.
Serum Institute has partnered with AstraZeneca to manufacture the vaccine, declaring in a statement that it will manufacture a billion doses of the vaccine after clearance from regulatory authorities.
Serum Institute of India is also currently carrying out a randomized, double-blind study of a recombinant BCG vaccine (VPM1002) for severe cases of coronavirus infection. The vaccine is a further development of the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine that is still widely used to treat tuberculosis. In the ongoing Phase 3 trials in 5,946 volunteers, Serum Institute is testing whether the vaccine reduces the severity of COVID-19 in high-risk patients.
with inputs from wires
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