Pune: Officials at the experimental location are set to test the Intranasal Bharat Biotech vaccine, BBV154, told TI on Tuesday that with an all-round Omicron outstanding, it would be a challenge to find volunteers who do not have covid.
Dr.
Aniket Joshi, the main researcher for the trial at Oyster & Pearl Hospitals, Pune, said participants at the trial must fulfill the two main criteria – they should not have a Covid medical history, and must be not vaccinated.
He said, “And Pune has become a very active city as far as covid and vaccination.
Many are vaccinated or have a virus.
It can make difficult task volunteers.” Officials said the phase 3 trial of the Intrasal vaccine had not yet begun, with most study sites awaiting approval from the Ethics Committee.
Dr.
Joshi said Pune, which has spread a vast Omicron, also reached 100% of the first dose coverage last year.
“So there might be a little bag in the city with a vaccine-naive group and people who haven’t arrested Omicron during the third wave,” he added.
An experimental site investigator said before Omicron, they would receive phone calls from people – all without a history of infection and willing to be part of the trial.
“But that might not happen now,” he said.
Dr.
Joshi, however, said that the approval of the Entry Ethics Committee, the hospital trial site hoped to recruit nearly 150 volunteers.
He said, “We will do everything we can to find volunteers, because this trial is very important.
Not only will it estimate blood serum antibodies after shots, but will also assess immunogenicity mediated by cells induced by vaccines and specific T-T-cells of antigens.
Response-B cells, which can be a relevant secondary result of this study.
“A official from a site in New Delhi said,” It might be very difficult to find volunteers because the rules of state volunteers should not be contracted by Covid, forever.
This is because of the quality of antibodies After a natural infection is better than after vaccination.
” Dr.
Savita Verma, investigators on the site in Pandit Bhagwat Dayal Sharma Institute of Medical Sciences, in Rohtak, Haryana, said rural areas were more likely to still have unvaccinated individuals.
He said, “Last year, when we finished recruiting to trial MRNA vaccines, we got several questions from rural areas, from people who qualified.” Even before the spread of Omicron, the experimental site for the MRNA vaccine, HGCO19, had difficulty finding volunteers who qualified, especially due to high vaccination.
“Sponsor the trial then let’s recruit people who have Covid antibodies in serum.
But one rule that lives is that 90 days must pass after an infection for someone who qualifies,” said an official of HgCo19.