The All India Institute of Medical Sciences, Delhi (AIIMS) will start a booster dose trial of Indian firm Bharat Biotech’s intranasal Covid-19 vaccine from Friday.
The booster dose will be given to those who have received two vaccine shots of either Covaxin or the Covishield jab, at least five months ago. The Drugs Controller General of India (DCGI) had given permission to the firm in January to conduct a Phase-III randomised and multi-centric study of the intra-nasal jab as a booster.
News18 had a month ago reported on the trial, which, according to sources, will be conducted on more than 800 participants.
While Covaxin and Serum Institute of India’s Covishield are already being used in India’s vaccination drive against Covid-19, BBV154 intranasal vaccine is Bharat Biotech’s novel adenovirus vectored vaccine, which is needle-free and likely to prevent Covid-19 infection as well.
The objective of the trial — titled as ‘Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated with EUA Vaccines’ — is to understand the best combination of heterologous boosting.
The purpose of the study is to evaluate the immunogenicity and safety of three vaccines when administered as a booster dose in individuals previously vaccinated in India.
Post two months of vaccination, an interim report will be notified to the Central Drugs Standard Control Organization (CDSCO).
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