Zydus Cadila begins enrolment for  Phase 3 vaccine trial: Reports

New Delhi: Zydus Cadila has begun enrolling and dosing participants for the phase 3 trial in India to determine the efficacy of its covid-19 vaccine ZyCov-D, two executives at the drugmaker said, in a step that could bring India closer to greater availability of vaccines.

“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.

Zydus Cadila plans to recruit 28,216 volunteers across five sites in four cities, according to information it provided on the government’s clinical trial registry. In contrast, Bharat Biotech enrolled 25,800 participants across 26 sites in 23 cities for its Phase 3 trial of Covaxin.

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. A company spokesperson was not immediately available for comment.

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.

As per the protocol for the trial, the vaccine will be tested to primarily see how effective it is in preventing confirmed symptomatic covid-19 cases as compared to placebo.

The first interim reading of efficacy of the vaccine will be determined two weeks after the third shot, as per the protocol.

Secondary outcomes of the trial include determining the efficacy of ZyCoV-D at preventing severe infection, death as well as persistence of immune response following the first dose.

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.