The Drugs Controller General of India (DCGI) has given approval to Reliance Life Sciences to conduct a Phase I clinical trial of its Covid-19 vaccine with certain conditions.
This trial will evaluate the safety, tolerability and immunogenicity of Reliance’s vaccine against Covid-19 infection in healthy subjects.
The trial will also analyse the maximum tolerated dose of the two-dose vaccine, reported PTI.
The Phase I trial usually lasts for 58 days.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had recommended commencement of Phase I trials of the SARS-CoV-2 recombinant Covid vaccine candidate.
The DCGI conditions requires the firm to submit the updated clinical trial protocol for immunogenicity to be analysed on day 42, instead of 14.
Reliance will conduct the trial at eight centres in Maharashtra state.
Last year, the development of the firm’s recombinant protein-based vaccine reportedly commenced.
So far, the Indian regulatory authority granted emergency use authorisation to six Covid-19 vaccines.
These vaccines comprise Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V, Moderna’s vaccine and Johnson & Johnson’s vaccine.