With no Aug 15 deadline, Covaxin clinical trial timelines get site-specific

Sites may end with varying timeline based on site initiation visit by Bharat Biotech

After the country's apex health research institute tried to allay concerns over setting a hurried deadline to find India's indigenous Covid-19 vaccine candidate, it is up to clinical sites to ensure that the trials happen swiftly, but by following due process. Sites that Business Standard spoke to say that each of them might take their own time, which will depend on getting logistics right before volunteer recruitment begin.

There are 12 sites in all across India in which both private and public hospitals that are conducting phase-1 and phase-2 human clinical trials for Bharat Biotech's Covaxin. 

Based on the earlier letter of Indian Council of Medical Research to the 12 sites, volunteer recruitment for clinical trials were to begin by July 7. However, at least three sites are yet to start the process. 

For instance, at Jeevan Rekha Hospital in Belgaum, one of the 12 clinical trial sites, the investigators are awaiting further communication from ICMR and Bharat Biotech with even volunteer screening, let alone recruitment, yet to begin anytime soon.Similarly, Institute of Medical Sciences and SUM Hospital in Bhubaneswar, Odisha, is awaiting a Site Initiation Visit (SIV) by the sponsor Bharat Biotech. Another site in South India said that they have not yet started screening patients and the site initiation process is awaited. 

"We will start recruiting within two to three days or so. We will follow a 28-day timeline for phase 1 . Once the phase 1 trials are completed and data duly analysed, we will start phase-2. The total process may take 180-days or so,"said a site lead who did not wish to be named. 

Meanwhile, Jaipur site said they are awaiting the vaccine samples. 

"The SIV is conducted to check whether all safety protocols for the clinical trials are being met or not. This is yet to happen and should be completed in a day or two. It is only after the SIV that the site can begin screening volunteers for recruitment for clinical trials or even receive vaccine samples from the sponsor. The timeline for clinical trials are now site specific," said Dr Ventaka Rao at Institute of Medical Sciences and SUM Hospital.

Before ICMR retracted the August 15 deadline, clinical trial sites were divided in their opinion on the timeline as well as the protocols to be followed for the clinical trials. Some even said phase 1 and 2 would be conducted together and trial can end within a month, while most other felt that it was impossible to stick to the deadline.

For instance, Dr Chandrasekhar Gillurkar of Gillukar Multispeciality Hospital in Nagpur, one of the 12 sites, had told Business Standard that after vaccine is given (counted as Day Zero), the site will wait for 14-days or so. The second dose will be given before the 14th day. After the second dose, these volunteers will be again checked after 14-days to see if they develop antibodies.

Phase-1 and 2 trials will be on 1,125 people, of which 375 volunteers will be in phase-1. Sources revealed that after the phase-2 ends, the country's drug regulator is likely to take a call on whether to launch the vaccine on compassionate use grounds, at least for healthcare workers.