Bharat Biotech has obtained permission from the Drugs Controller General of India (DCGI) to conduct a Phase III clinical trial of the booster doses of its intranasal Covid-19 vaccine.
Named BBV154, the vaccine is being developed by the company under a licencing agreement with Washington University School of Medicine in St Louis, US.
Only the vaccine batches certified by the Central Drugs Laboratory (CDL), Kasauli, will be utilised in the trial.
The trial will be carried out at nine study centres, including sites in All India Institute of Medical Sciences, New Delhi and Bihar.
A two-dose initial vaccine series, as well as the booster dose regimen of BBV154, will be analysed in the trial.
The booster shot will be analysed in people who already received the Covid-19 vaccines, Covishield and Covaxin, Livemint reported.
Bharat Biotech intends to enrol 5,000 participants with 50% inoculated with Covishield and 50% Covaxin.
An interval of six months will be maintained between the second vaccine dose and booster, sources added.
The multicentre, randomised, open-label study will analyse the safety and immunogenicity of the intranasal vaccine as a booster dose in subjects inoculated with Covid-19 shots approved for use under New Drugs & Clinical Trials Rules, 2019, PTI reported.
Earlier this month, the Subject Experts Committee (SEC) of the DCGI granted approval to the company to commence Phase III and heterologous trials of the Covid-19 intranasal vaccine booster.
Bharat Biotech sought DCGI approval to start the Phase III trial of BBV154 as a booster dose in December.