Zydus Cadila begins enrolment for  Phase 3 vaccine trial: Reports

New Delhi, Jan 22: Zydus Cadila has started enrolling and dosing participants in India for the Phase 3 clinical trial of its three-dose COVID-19 vaccine ZyCoV-D, according to reports.

The trials are expected to take place across four cities - Surat, Nashik, Jaipur and Ahmedabad.

Zydus Cadila received DCGI's approval earlier this month to initiate Phase 3 trials in 26,000 Indian participants.

"We started enrolment and dosing of participants from Saturday. The enrolment and dosing happens between 9am and 5pm," the principal investigator at a trial site, one of the two people mentioned above, said on condition of anonymity.

Unlike Covaxin and Covishield which are two-dose vaccines given 28 days apart as an intramuscular injection, Zydus Cadila's ZyCoV-D requires three shots given intradermally. The second and third shots are given 28 and 56 days after the first.

The five sites are Zydus Hospitals and Healthcare Research Pvt. Ltd at Ahmedabad, BAPS Pramukh Swami Hospital at Surat, HCG Manavata Cancer Centre at Nashik, and Imperial Hospital & Research Center and Marudhar Hospital in Jaipur, according to the clinical trial registry.

People of 12 years and above will be eligible for recruitment if they did not have fever or any acute illness or infection four weeks prior to the enrolment and have not had laboratory-confirmed covid-19. Volunteers should also not have had hypersensitivity reaction or any serious adverse event after any vaccination.