Serum Institute gets DCGI nod to start phase 2 and 3 trials of Oxford vaccine in IndiaAugust 3, 2020 0 By FM
The Serum Institute of India (SII) received the Drugs Controller General of India (DCGI) nod to conduct phase 2 and 3 clinical trials of COVID-19 vaccine candidate developed by Oxford University in partnership with AstraZeneca.
As per the study design, each subject will be administered two doses four weeks apart with the first dose on day one and a second dose on day 29. The safety and immunogenicity will be then assessed at predefined intervals.
The officials said that the SII had submitted a revised proposal to the DCGI on Wednesday.The expert panel, after deliberating the initial submission, had asked the Pune-based vaccine maker to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.
The clinical trial sites which have been proposed for the study are distributed across 17 different sites in India including AIIMS Delhi, AIIMS-Jodhpur, 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, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam, and JSS Academy of Higher Education and Research in Mysore.
The observer-blind, randomised controlled study of the experimental vaccine shall include 1,600 healthy participants aged above 18 years across India. The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB) to the Central Drugs Standard Control Organisation (CDSCO) before proceeding to phase 3 clinical trials, a senior health ministry official said.
Currently, the Oxford vaccine candidate is undergoing clinical trials in the UK, Brazil and South Africa.