Zydus Cadila gets DCGI nod to start Phase III ZyCoV-D trial

Zydus Cadila, a part of Cadila Healthcare (BOM: 532321), on Sunday announced that it will be starting Phase III clinical of ZyCoV-D, its plasmid DNA vaccine to prevent COVID-19, after having received permissions from the Drugs Controller General of India (DCGI).

The company will now be initiating Phase III clinical trial in around 30,000 volunteers. ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical t

The Phase II study of the vaccine ZyCoV-D had been conducted in over 1,000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomized, double-blind placebo-controlled study. The vaccine was found to be safe and elicit a strong immunogenic response. The trial has reviewed by an independent Data Safety Monitoring Board (DSMB) and reports were submitted to Central Drugs Standard Control Organization (CDSCO) regularly for the update on safety outcome.